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| ID | Type | Description | Link |
|---|---|---|---|
| CCLG561X2201 | Other Identifier | Novartis Institutes for BioMedical Research |
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| Name | Class |
|---|---|
| Novartis Institutes for BioMedical Research | OTHER |
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The purpose of this study is to evaluate the safety and efficacy of 12 (every 28 days) intravitreal (IVT) injections of CLG561 as a monotherapy and in combination with LFG316 as compared to sham in subjects with geographic atrophy.
This study consists of an up-to 30-day screening period, an approximately 336-day treatment period, and a follow-up period consisting of two visits occurring 4 and 16 weeks after the last administered injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLG561 | Experimental | CLG561 10 mg, one IVT injection every 28 days for a total of 12 injections |
|
| CLG561+LFG316 | Experimental | CLG561 5mg + LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections |
|
| Sham Injection | Sham Comparator | One sham injection every 28 days for total of 12 sham injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLG561 | Drug |
| ||
| LFG316 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug | A serious adverse event (SAE) was defined as any adverse experience that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All SAEs related to the study drug are reported. No statistical analysis was conducted. | Up to Day 421 |
| Mean Change From Baseline in Intraocular Pressure (IOP) | IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline is defined as the last measurement prior to first dose of treatment. A more negative change indicates a greater amount of improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted. | Baseline (Day 1), Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309 |
| Change in GA Lesion Size From Baseline to Day 337 as Measured by Fundus Autofluorescence (FAF) | Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis. | Baseline (Day 1), Day 337 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF | Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr Clinical Manager, Pharma, GCRA | Alcon Research | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37314061 | Derived | Tzoumas N, Riding G, Williams MA, Steel DH. Complement inhibitors for age-related macular degeneration. Cochrane Database Syst Rev. 2023 Jun 14;6(6):CD009300. doi: 10.1002/14651858.CD009300.pub3. |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
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This reporting group includes all randomized participants.
Subjects were recruited from 28 sites in the US and Puerto Rico.
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| ID | Title | Description |
|---|---|---|
| FG000 | CLG561 | CLG561 10 mg, one intravitreal (IVT) injection every 28 days for a total of 12 injections |
| FG001 | CLG561+LFG316 | CLG561 5 mg +LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections |
| FG002 | Sham Injection | One sham injection every 28 days for total of 12 sham injections |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set
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| ID | Title | Description |
|---|---|---|
| BG000 | CLG561 | CLG561 10 mg, one IVT injection every 28 days for a total of 12 injections |
| BG001 | CLG561+LFG316 | CLG561 5 mg + LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug | A serious adverse event (SAE) was defined as any adverse experience that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All SAEs related to the study drug are reported. No statistical analysis was conducted. | Safety Analysis Set | Posted | Number | subjects | Up to Day 421 |
|
Day 1 through study completion, an average of 336 days
Adverse Events (AEs) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. Safety Analysis Set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CLG561 | All subjects exposed to CLG561 10 mg | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior chamber cell | Eye disorders | MedDRA (18.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| WW Brand Medical Director Ophtha, GMA Ophthalmics | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 8, 2018 | Nov 5, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 20, 2016 | Nov 5, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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|
| Sham injection | Drug | Empty syringe (without a needle) placed against the eye |
|
| Baseline (Day 1), Day 85, Day 169, Day 253 |
| Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by FAF | Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis. Day 421 measurements were only summarized descriptively and did not include any statistical modeling. | Baseline (Day 1), Day 421 |
| Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | BCVA was assessed using ETDRS testing at 4 meters. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. | Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 30, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 |
| Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Low Luminance Visual Acuity (VA) was assessed using ETDRS testing at 4 meters with a neutral density filter to reduce chart luminance to 3 candelas/m2. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. | Baseline (Day 1), Day 2, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 |
| Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Low Luminance Visual Acuity (VA) was assessed using ETDRS testing at 4 meters with a neutral density filter to reduce chart luminance to 3 candelas/m2. A deficit in LLVA is defined as a loss in letters read from baseline. Baseline is defined as the last measurement prior to first dose of treatment. A negative change value indicates improvement (more letters read). One eye (study eye) contributed to the analysis. | Baseline (Day 1), Day 2, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 |
| Average Change in BCVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS | BCVA was assessed using ETDRS testing at 4 meters. Day 281, Day 309, and Day 337 were averaged and compared to baseline. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted. | Baseline (Day 1), Day 281, Day 309, Day 337 |
| Average Change in LLVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS | LLVA was assessed at 4 meters using a neutral density filter to reduce chart luminance to 3 candelas/m2. Baseline is defined as the last measurement prior to first dose of treatment. Day 281, Day 309, and Day 337 were averaged and compared to baseline. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted. | Baseline (Day 1), Day 281, Day 309, Day 337 |
| Average LLVA Deficit (Letters) Change From Baseline at Day 281 to Day 337 as Measured by ETDRS | LLVA was assessed at 4 meters using a neutral density filter to reduce chart luminance to 3 candelas/m2. A deficit in LLVA is defined as a loss in letters read from baseline. Baseline is defined as the last measurement prior to first dose of treatment. Day 281, Day 309, and Day 337 were averaged and compared to baseline. A negative change value indicates improvement (more letters read). One eye (study eye) contributed to the analysis. | Baseline (Day 1), Day 281, Day 309, Day 337 |
| Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | BCVA was assessed using ETDRS testing at 4 meters. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment and is reported categorically. One eye (study eye) contributed to the analysis. No statistical analysis was conducted. | Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 30, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 |
| Total CLG561 Serum Concentrations up to Day 421 | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. | Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 85, Day 169, Day 253, Day 309, Day 337, Day 421 |
| Total LFG316 Serum Concentration up to Day 421 | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. | Baseline (Day 1), Day 337, Day 421 |
| Percentage of Subjects With Anti-CLG561 Antibodies up to Day 421 | Samples were collected and assessed for anti-CLG561 antibodies. | Baseline (Day 1), up to Day 421 |
| Percentage of Subjects With Anti-LFG316 Antibodies up to Day 421 | Samples were collected and assessed for anti-LFG316 antibodies. | Baseline (Day 1), up to Day 421 |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG002 | Sham Injection | One sham injection every 28 days for total of 12 sham injections |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
CLG561 5 mg + LFG316 5 mg, one IVT injection every 28 days for a total of 12 injections |
| OG002 | Sham Injection | One sham injection every 28 days for total of 12 sham injections |
|
|
| Primary | Mean Change From Baseline in Intraocular Pressure (IOP) | IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry and reported in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). Baseline is defined as the last measurement prior to first dose of treatment. A more negative change indicates a greater amount of improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted. | Safety Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | Mean | Standard Deviation | mmHg | Baseline (Day 1), Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309 |
|
|
|
| Primary | Change in GA Lesion Size From Baseline to Day 337 as Measured by Fundus Autofluorescence (FAF) | Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis. | PPS. Only subjects with a value at both baseline and that time point are included. | Posted | Least Squares Mean | 80% Confidence Interval | square millimeters (mm2) | Baseline (Day 1), Day 337 |
|
|
|
|
| Secondary | Change in GA Lesion Size From Baseline to Day 85, 169, and 253 as Measured by FAF | Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis. | PPS. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | Least Squares Mean | 80% Confidence Interval | mm2 | Baseline (Day 1), Day 85, Day 169, Day 253 |
|
|
|
|
| Secondary | Mean Change in GA Lesion Size From Baseline to Day 421 as Measured by FAF | Geographic atrophy, also known as atrophic age-related macular degeneration (AMD) or advanced dry AMD, is an advanced form of age-related macular degeneration that can result in the progressive and irreversible loss of retina which can lead to a loss of visual function over time. Geographic atrophy (GA) lesion size was assessed by a Central Reading Center (CRC) using FAF. Baseline is defined as the last measurement prior to first dose of treatment. One eye (study eye) contributed to the analysis. Day 421 measurements were only summarized descriptively and did not include any statistical modeling. | PPS. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | Mean | Standard Deviation | mm2 | Baseline (Day 1), Day 421 |
|
|
|
| Secondary | Change in Best Corrected Visual Acuity (BCVA) From Baseline by Visit up to Day 337 as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) | BCVA was assessed using ETDRS testing at 4 meters. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. | FAS. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | Least Squares Mean | 80% Confidence Interval | letters | Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 30, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 |
|
|
|
|
| Secondary | Change in Low Luminance Visual Acuity (LLVA) From Baseline up to Day 337 as Measured by ETDRS | Low Luminance Visual Acuity (VA) was assessed using ETDRS testing at 4 meters with a neutral density filter to reduce chart luminance to 3 candelas/m2. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. | FAS. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | Least Squares Mean | 80% Confidence Interval | letters | Baseline (Day 1), Day 2, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 |
|
|
|
|
| Secondary | Change in LLVA Deficit From Baseline up to Day 337 as Measured by ETDRS | Low Luminance Visual Acuity (VA) was assessed using ETDRS testing at 4 meters with a neutral density filter to reduce chart luminance to 3 candelas/m2. A deficit in LLVA is defined as a loss in letters read from baseline. Baseline is defined as the last measurement prior to first dose of treatment. A negative change value indicates improvement (more letters read). One eye (study eye) contributed to the analysis. | FAS. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | Least Squares Mean | 80% Confidence Interval | letters | Baseline (Day 1), Day 2, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 |
|
|
|
|
| Secondary | Average Change in BCVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS | BCVA was assessed using ETDRS testing at 4 meters. Day 281, Day 309, and Day 337 were averaged and compared to baseline. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted. | PPS. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | Mean | Standard Deviation | letters | Baseline (Day 1), Day 281, Day 309, Day 337 |
|
|
|
| Secondary | Average Change in LLVA From Baseline to the Period Day 281 to Day 337 as Measured by ETDRS | LLVA was assessed at 4 meters using a neutral density filter to reduce chart luminance to 3 candelas/m2. Baseline is defined as the last measurement prior to first dose of treatment. Day 281, Day 309, and Day 337 were averaged and compared to baseline. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. No statistical analysis was conducted. | PPS. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | Mean | Standard Deviation | letters | Baseline (Day 1), Day 281, Day 309, Day 337 |
|
|
|
| Secondary | Average LLVA Deficit (Letters) Change From Baseline at Day 281 to Day 337 as Measured by ETDRS | LLVA was assessed at 4 meters using a neutral density filter to reduce chart luminance to 3 candelas/m2. A deficit in LLVA is defined as a loss in letters read from baseline. Baseline is defined as the last measurement prior to first dose of treatment. Day 281, Day 309, and Day 337 were averaged and compared to baseline. A negative change value indicates improvement (more letters read). One eye (study eye) contributed to the analysis. | PPS. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | Mean | Standard Deviation | letters | Baseline (Day 1), Day 281, Day 309, Day 337 |
|
|
|
| Secondary | Percentage of Subjects With Letter Change in BCVA From Baseline up to Day 337 as Measured by ETDRS | BCVA was assessed using ETDRS testing at 4 meters. Baseline is defined as the last measurement prior to first dose of treatment. BCVA change was defined as a change in letters read from the baseline assessment and is reported categorically. One eye (study eye) contributed to the analysis. No statistical analysis was conducted. | FAS. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | Number | percentage of subjects | Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 30, Day 57, Day 85, Day 113, Day 141, Day 169, Day 197, Day 225, Day 253, Day 281, Day 309, Day 337 |
|
|
|
| Secondary | Total CLG561 Serum Concentrations up to Day 421 | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. | PK Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | Mean | Standard Deviation | ng/mL | Baseline (Day 1), Day 2, Day 8, Day 15, Day 29, Day 85, Day 169, Day 253, Day 309, Day 337, Day 421 |
|
|
|
| Secondary | Total LFG316 Serum Concentration up to Day 421 | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. | PK Analysis Set. At each time point, only subjects with a value at both baseline and that time point are included. | Posted | Mean | Standard Deviation | ng/mL | Baseline (Day 1), Day 337, Day 421 |
|
|
|
| Secondary | Percentage of Subjects With Anti-CLG561 Antibodies up to Day 421 | Samples were collected and assessed for anti-CLG561 antibodies. | IG analysis set: All subjects in the safety analysis set with evaluable immunogenicity (IG) data and with no major protocol deviations that had an impact on the assessment of immunogenicity. | Posted | Number | percentage of subjects | Baseline (Day 1), up to Day 421 |
|
|
|
| Secondary | Percentage of Subjects With Anti-LFG316 Antibodies up to Day 421 | Samples were collected and assessed for anti-LFG316 antibodies. | IG analysis set: All subjects in the safety analysis set with evaluable immunogenicity (IG) data and with no major protocol deviations that had an impact on the assessment of immunogenicity. | Posted | Number | percentage of subjects | Baseline (Day 1), up to Day 421 |
|
|
|
| 36 |
| 5 |
| 36 |
| 27 |
| 36 |
| EG001 | CLG561+LFG316 | All subjects exposed to CLG561 5 mg + LFG316 5 mg | 0 | 39 | 5 | 39 | 31 | 39 |
| EG002 | Sham Injection | All subjects exposed to sham injection | 1 | 39 | 7 | 39 | 29 | 39 |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (18.0) | Systematic Assessment |
|
| Blindness | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Clostridium difficile colitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Endophthalmitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Cataract traumatic | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
|
| Ureteric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Mental status changes | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Anterior chamber flare | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Cataract nuclear | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Dry age-related macular degeneration | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Iridocyclitis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Metamorphopsia | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Photophobia | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Posterior capsule opacification | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Vitreal cells | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Vitreous opacities | Eye disorders | MedDRA (18.0) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (18.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (18.0) | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA (18.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (18.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA (18.0) | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA (18.0) | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA (18.0) | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA (18.0) | Systematic Assessment |
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| Prothrombin time prolonged | Investigations | MedDRA (18.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (18.0) | Systematic Assessment |
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| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA (18.0) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (18.0) | Systematic Assessment |
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| Renal cyst | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | MedDRA (18.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (18.0) | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| Change from BL at Day 29 |
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| Change from BL at Day 57 |
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| Change from BL at Day 85 |
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| Change from BL at Day 113 |
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| Change from BL at Day 141 |
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| Change from BL at Day 169 |
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| Change from BL at Day 197 |
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| Change from BL at Day 225 |
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| Change from BL at Day 253 |
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| Change from BL at Day 281 |
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| Change from BL at Day 309 |
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Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations. |
| ANCOVA |
| 0.1019 |
| Treatment Effect |
| -0.29 |
| 2-Sided |
| 80 |
| -0.59 |
| 0.00 |
| Superiority |
| Least squares mean for change from baseline from ANCOVA model with treatment, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal), baseline lesion size as covariates after multiple imputations. | ANCOVA | 0.5987 | Treatment Effect | 0.06 | 2-Sided | 80 | -0.24 | 0.35 | Superiority |
| Change from BL at Day 169 |
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| Change from BL at Day 253 |
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| Change from baseline at Day 85 | Mixed Models Analysis | 0.6820 | Treatment Effect | 0.04 | 2-Sided | 80 | -0.07 | 0.14 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 85 | Mixed Models Analysis | 0.6826 | Treatment Effect | 0.04 | 2-Sided | 80 | -0.07 | 0.14 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 169 | Mixed Models Analysis | 0.1545 | Treatment Effect | -0.12 | 2-Sided | 80 | -0.28 | 0.03 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 169 | Mixed Models Analysis | 0.1398 | Treatment Effect | -0.13 | 2-Sided | 80 | -0.29 | 0.02 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 169 | Mixed Models Analysis | 0.4717 | Treatment Effect | -0.01 | 2-Sided | 80 | -0.16 | 0.14 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 253 | Mixed Models Analysis | 0.0530 | Treatment Effect | -0.25 | 2-Sided | 80 | -0.45 | -0.05 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 253 | Mixed Models Analysis | 0.1386 | Treatment Effect | -0.17 | 2-Sided | 80 | -0.37 | 0.03 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 253 | Mixed Models Analysis | 0.7087 | Treatment Effect | 0.08 | 2-Sided | 80 | -0.11 | 0.27 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from Baseline at Day 421 |
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| Change from BL at Day 8 |
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| Change from BL at Day 15 |
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| Change from BL at Day 29 |
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| Change from BL at Day 30 |
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| Change from BL at Day 57 |
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| Change from BL at Day 85 |
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| Change from BL at Day 113 |
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| Change from BL at Day 141 |
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| Change from BL at Day 169 |
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| Change from BL at Day 197 |
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| Change from BL at Day 225 |
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| Change from BL at Day 253 |
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| Change from BL at Day 281 |
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| Change from BL at Day 309 |
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| Change from BL at Day 337 |
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| Change from baseline at Day 2 | Mixed Models Analysis | 0.3929 | Treatment Effect | 0.51 | 2-Sided | 80 | -1.89 | 2.91 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 2 | Mixed Models Analysis | 0.0418 | Treatment Effect | 3.23 | 2-Sided | 80 | 0.85 | 5.61 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 8 | Mixed Models Analysis | 0.5632 | Treatment Effect | -0.32 | 2-Sided | 80 | -2.91 | 2.27 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 8 | Mixed Models Analysis | 0.2575 | Treatment Effect | 1.29 | 2-Sided | 80 | -1.25 | 3.83 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 8 | Mixed Models Analysis | 0.2058 | Treatment Effect | 1.61 | 2-Sided | 80 | -0.91 | 4.12 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 15 | Mixed Models Analysis | 0.8392 | Treatment Effect | -1.94 | 2-Sided | 80 | -4.44 | 0.57 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 15 | Mixed Models Analysis | 0.5255 | Treatment Effecgt | -0.12 | 2-Sided | 80 | -2.59 | 2.35 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 15 | Mixed Models Analysis | 0.1685 | Treatment Effect | 1.81 | 2-Sided | 80 | -0.61 | 4.24 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 29 | Mixed Models Analysis | 0.8544 | Treatment | -2.01 | 2-Sided | 80 | -4.45 | 0.43 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 29 | Mixed Models Analysis | 0.1402 | Treatment Effect | 2.03 | 2-Sided | 80 | -0.38 | 4.44 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 29 | Mixed Models Analysis | 0.0150 | Treatment Effect | 4.03 | 2-Sided | 80 | 1.67 | 6.40 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 30 | Mixed Models Analysis | 0.4682 | Treatment Effect | 0.14 | 2-Sided | 80 | -2.11 | 2.39 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 30 | Mixed Models Analysis | 0.4125 | Treatment Effect | 0.38 | 2-Sided | 80 | -1.84 | 2.60 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 30 | Mixed Models Analysis | 0.4431 | Treatment Effect | 0.24 | 2-Sided | 80 | -1.94 | 2.42 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 57 | Mixed Models Analysis | 0.6924 | Treatment Effect | -1.04 | 2-Sided | 80 | -3.72 | 1.63 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 57 | Mixed Models Analysis | 0.6160 | Treatment Effect | -0.61 | 2-Sided | 80 | -3.26 | 2.04 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 57 | Mixed Models Analysis | 0.4149 | Treatment Effect | 0.44 | 2-Sided | 80 | -2.18 | 3.06 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 85 | Mixed Models Analysis | 0.2582 | Treatment Effect | 1.29 | 2-Sided | 80 | -1.27 | 3.85 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 85 | Mixed Models Analysis | 0.3402 | Treatment Effect | 0.81 | 2-Sided | 80 | -1.72 | 3.34 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 85 | Mixed Models Analysis | 0.5976 | Treatment Effect | -0.48 | 2-Sided | 80 | -2.99 | 2.03 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 113 | Mixed Models Analysis | 0.5916 | Treatment Effect | -0.50 | 2-Sided | 80 | -3.30 | 2.29 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 113 | Mixed Models Analysis | 0.5564 | Treatment Effect | -0.30 | 2-Sided | 80 | -3.05 | 2.45 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 113 | Mixed Models Analysis | 0.4625 | Treatment Effect | 0.20 | 2-Sided | 80 | -2.53 | 2.93 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 141 | Mixed Models Analysis | 0.8221 | Treatment Effect | -1.94 | 2-Sided | 80 | -4.64 | 0.76 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 141 | Mixed Models Analysis | 0.3179 | Treatment Effect | 0.98 | 2-Sided | 80 | -1.68 | 3.64 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 141 | Mixed Models Analysis | 0.0773 | Treatment Effect | 2.92 | 2-Sided | 80 | 0.29 | 5.55 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 169 | Mixed Models Analysis | 0.6708 | Treatment Effect | -0.95 | 2-Sided | 80 | -3.71 | 1.81 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 169 | Mixed Models Analysis | 0.6790 | Treatment Effect | -0.99 | 2-Sided | 80 | -3.71 | 1.74 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 169 | Mixed Models Analysis | 0.5070 | Treatment Effect | -0.04 | 2-Sided | 80 | -2.72 | 2.64 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 197 | Mixed Models Analysis | 0.5487 | Treatment Effect | -0.30 | 2-Sided | 80 | -3.44 | 2.84 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 197 | Mixed Models Analysis | 0.6973 | Treatment Effect | -1.25 | 2-Sided | 80 | -4.35 | 1.85 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 197 | Mixed Models Analysis | 0.6548 | Treatment Effect | -0.95 | 2-Sided | 80 | -4.00 | 2.11 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 225 | Mixed Models Analysis | 0.5533 | Treatment Effect | -0.35 | 2-Sided | 80 | -3.76 | 3.05 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 225 | Mixed Models Analysis | 0.3358 | Treatment Effect | 1.11 | 2-Sided | 80 | -2.25 | 4.46 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 225 | Mixed Models Analysis | 0.2850 | Treatment Effect | 1.46 | 2-Sided | 80 | -1.85 | 4.77 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 253 | Mixed Models Analysis | 0.5778 | Treatment Effect | -0.55 | 2-Sided | 80 | -4.14 | 3.04 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 253 | Mixed Models Analysis | 0.2018 | Treatment Effect | 2.30 | 2-Sided | 80 | -1.24 | 5.85 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 253 | Mixed Models Analysis | 0.1457 | Treatment Effect | 2.85 | 2-Sided | 80 | -0.62 | 6.32 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 281 | Mixed Models Analysis | 0.5758 | Treatment Effect | -0.56 | 2-Sided | 80 | -4.29 | 3.18 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 281 | Mixed Models Analysis | 0.3833 | Treatment Effect | 0.85 | 2-Sided | 80 | -2.84 | 4.55 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 281 | Mixed Models Analysis | 0.3083 | Treatment Effect | 1.41 | 2-Sided | 80 | -2.21 | 5.02 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 309 | Mixed Models Analysis | 0.7063 | Treatment Effect | -1.54 | 2-Sided | 80 | -5.19 | 2.11 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 309 | Mixed Models Analysis | 0.2227 | Treatment Effect | 2.14 | 2-Sided | 80 | -1.46 | 5.74 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 309 | Mixed Models Analysis | 0.0907 | Treatment Effect | 3.68 | 2-Sided | 80 | 0.15 | 7.21 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 337 | Mixed Models Analysis | 0.4799 | Treatment Effect | 0.17 | 2-Sided | 80 | -4.23 | 4.57 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 337 | Mixed Models Analysis | 0.5237 | Treatment Effect | -0.20 | 2-Sided | 80 | -4.54 | 4.14 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 337 | Mixed Models Analysis | 0.5451 | Treatment Effect | -0.37 | 2-Sided | 80 | -4.62 | 3.87 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from BL at Day 29 |
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| Change from BL at Day 57 |
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| Change from BL at Day 85 |
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| Change from BL at Day 113 |
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| Change from BL at Day 141 |
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| Change from BL at Day 169 |
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| Change from BL at Day 197 |
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| Change from BL at Day 225 |
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| Change from BL at Day 253 |
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| Change from BL at Day 281 |
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| Change from BL at Day 309 |
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| Change from BL at Day 337 |
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| Change from baseline at Day 2 | Mixed Models Analysis | 0.3771 | Treatment Effect | 0.46 | 2-Sided | 80 | -1.44 | 2.37 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 2 | Mixed Models Analysis | 0.4161 | Treatment Effect | 0.32 | 2-Sided | 80 | -1.60 | 2.24 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 29 | Mixed Models Analysis | 0.9385 | Treatment Effect | -2.88 | 2-Sided | 80 | -5.26 | -0.49 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 29 | Mixed Models Analysis | 0.5862 | Treatment Effect | -0.40 | 2-Sided | 80 | -2.76 | 1.96 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 29 | Mixed Models Analysis | 0.0875 | Treatment Effect | 2.48 | 2-Sided | 80 | 0.14 | 4.82 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 57 | Mixed Models Analysis | 0.4059 | Treatment Effect | 0.53 | 2-Sided | 80 | -2.32 | 3.37 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 57 | Mixed Models Analysis | 0.2860 | Treatment Effect | 1.24 | 2-Sided | 80 | -1.58 | 4.05 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 57 | Mixed Models Analysis | 0.3727 | Treatment Effect | 0.71 | 2-Sided | 80 | -2.10 | 3.52 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 85 | Mixed Models Analysis | 0.3360 | Treatment Effect | 0.91 | 2-Sided | 80 | -1.85 | 3.66 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 85 | Mixed Models Analysis | 0.0316 | Treatment Effect | 3.95 | 2-Sided | 80 | 1.24 | 6.66 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 85 | Mixed Models Analysis | 0.0762 | Treatment Effect | 3.04 | 2-Sided | 80 | 0.32 | 5.76 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 113 | Mixed Models Analysis | 0.0544 | Treatment Effect | 3.68 | 2-Sided | 80 | 0.75 | 6.61 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 113 | Mixed Models Analysis | 0.1955 | Treatment Effect | 1.91 | 2-Sided | 80 | -0.95 | 4.77 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 113 | Mixed Models Analysis | 0.7844 | Treatment Effect | -1.77 | 2-Sided | 80 | -4.65 | 1.12 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 141 | Mixed Models Analysis | 0.2973 | Treatment Effect | 1.49 | 2-Sided | 80 | -2.11 | 5.08 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 141 | Mixed Models Analysis | 0.3127 | Treatment Effect | 1.33 | 2-Sided | 80 | -2.18 | 4.84 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 141 | Mixed Models Analysis | 0.5227 | Treatment Effect | -0.16 | 2-Sided | 80 | -3.67 | 3.36 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 169 | Mixed Models Analysis | 0.7643 | Treatment Effect | -1.63 | 2-Sided | 80 | -4.54 | 1.28 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 169 | Mixed Models Analysis | 0.7331 | Treatment Effect | -1.38 | 2-Sided | 80 | -4.25 | 1.48 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 169 | Mixed Models Analysis | 0.4557 | Treatment Effect | 0.25 | 2-Sided | 80 | -2.59 | 3.09 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 197 | Mixed Models Analysis | 0.4549 | Treatment Effect | 0.29 | 2-Sided | 80 | -2.97 | 3.55 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 197 | Mixed Models Analysis | 0.3535 | Treatment Effect | 0.93 | 2-Sided | 80 | -2.26 | 4.13 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 197 | Mixed Models Analysis | 0.3970 | Treatment Effect | 0.65 | 2-Sided | 80 | -2.54 | 3.84 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 225 | Mixed Models Analysis | 0.2714 | Treatment Effect | 1.78 | 2-Sided | 80 | -1.99 | 5.55 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 225 | Mixed Models Analysis | 0.2741 | Treatment Effect | 1.72 | 2-Sided | 80 | -1.97 | 5.41 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 225 | Mixed Models Analysis | 0.5084 | Treatment Effect | -0.06 | 2-Sided | 80 | -3.74 | 3.62 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 253 | Mixed Models Analysis | 0.1537 | Treatment Effect | 2.82 | 2-Sided | 80 | -0.73 | 6.37 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 253 | Mixed Models Analysis | 0.2542 | Treatment Effect | 1.79 | 2-Sided | 80 | -1.69 | 5.27 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 253 | Mixed Models Analysis | 0.6504 | Treatment Effect | -1.03 | 2-Sided | 80 | -4.46 | 2.40 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 281 | Mixed Models Analysis | 0.3405 | Treatment Effect | 1.30 | 2-Sided | 80 | -2.78 | 5.38 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 281 | Mixed Models Analysis | 0.2194 | Treatment Effect | 2.41 | 2-Sided | 80 | -1.59 | 6.42 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 281 | Mixed Models Analysis | 0.3596 | Treatment Effect | 1.11 | 2-Sided | 80 | -2.87 | 5.09 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 309 | Mixed Models Analysis | 0.5086 | Treatment Effect | -0.07 | 2-Sided | 80 | -4.04 | 3.90 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 309 | Mixed Models Analysis | 0.2211 | Treatment Effect | 2.33 | 2-Sided | 80 | -1.57 | 6.23 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 309 | Mixed Models Analysis | 0.2126 | Treatment Effect | 2.40 | 2-Sided | 80 | -1.47 | 6.26 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 337 | Mixed Models Analysis | 0.2053 | Treatment Effect | 2.56 | 2-Sided | 80 | -1.44 | 6.55 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 337 | Mixed Models Analysis | 0.2353 | Treatment Effect | 2.20 | 2-Sided | 80 | -1.72 | 6.12 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 337 | Mixed Models Analysis | 0.5471 | Treatment Effect | -0.36 | 2-Sided | 80 | -4.24 | 3.53 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
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| Change from baseline at Day 2 | Mixed Models Analysis | 0.4454 | Treatment Effect | -0.28 | 2-Sided | 80 | -2.89 | 2.33 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 2 | Mixed Models Analysis | 0.8861 | Treatment Effect | 2.46 | 2-Sided | 80 | -0.16 | 5.08 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 29 | Mixed Models Analysis | 0.7130 | Treatment Effect | 1.16 | 2-Sided | 80 | -1.49 | 3.80 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 29 | Mixed Models Analysis | 0.8759 | Treatment Effect | 2.37 | 2-Sided | 80 | -0.26 | 5.01 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 29 | Mixed Models Analysis | 0.7256 | Treatment Effect | 1.22 | 2-Sided | 80 | -1.39 | 3.82 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 57 | Mixed Models Analysis | 0.3111 | Treatment Effect | -1.17 | 2-Sided | 80 | -4.22 | 1.88 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 57 | Mixed Models Analysis | 0.2360 | Treatment Effect | -1.70 | 2-Sided | 80 | -4.73 | 1.34 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 57 | Mixed Models Analysis | 0.4110 | Treatment Effect | -0.53 | 2-Sided | 80 | -3.55 | 2.49 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 85 | Mixed Models Analysis | 0.5247 | Treatment Effect | 0.13 | 2-Sided | 80 | -2.57 | 2.83 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 85 | Mixed Models Analysis | 0.0534 | Treatment Effect | -3.37 | 2-Sided | 80 | -6.04 | -0.70 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 85 | Mixed Models Analysis | 0.0475 | Treatment Effect | -3.50 | 2-Sided | 80 | -6.18 | -0.82 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 113 | Mixed Models Analysis | 0.0575 | Treatment Effect | -3.92 | 2-Sided | 80 | -7.11 | -0.74 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 113 | Mixed Models Analysis | 0.1876 | Treatment Effect | -2.16 | 2-Sided | 80 | -5.29 | 0.97 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 113 | Mixed Models Analysis | 0.7644 | Treatment Effect | 1.76 | 2-Sided | 80 | -1.38 | 4.91 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 141 | Mixed Models Analysis | 0.0838 | Treatment Effect | -3.85 | 2-Sided | 80 | -7.42 | -0.28 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 141 | Mixed Models Analysis | 0.4444 | Treatment Effect | -0.38 | 2-Sided | 80 | -3.89 | 3.13 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 141 | Mixed Models Analysis | 0.8977 | Treatment Effect | 3.47 | 2-Sided | 80 | -0.04 | 6.97 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 169 | Mixed Models Analysis | 0.4917 | Treatment Effect | -0.05 | 2-Sided | 80 | -2.92 | 2.82 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 169 | Mixed Models Analysis | 0.4909 | Treatment Effect | -0.05 | 2-Sided | 80 | -2.89 | 2.79 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 169 | Mixed Models Analysis | 0.4992 | Treatment Effect | -0.00 | 2-Sided | 80 | -2.82 | 2.81 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 197 | Mixed Models Analysis | 0.3285 | Treatment Effect | -1.09 | 2-Sided | 80 | -4.25 | 2.07 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 197 | Mixed Models Analysis | 0.1568 | Treatment Effect | -2.45 | 2-Sided | 80 | -5.57 | 0.67 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 197 | Mixed Models Analysis | 0.2867 | Treatment Effect | -1.36 | 2-Sided | 80 | -4.46 | 1.74 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 225 | Mixed Models Analysis | 0.0798 | Treatment Effect | -3.93 | 2-Sided | 80 | -7.51 | -0.35 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 225 | Mixed Models Analysis | 0.2962 | Treatment Effect | -1.47 | 2-Sided | 80 | -5.00 | 2.06 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 225 | Mixed Models Analysis | 0.8163 | Treatment Effect | 2.46 | 2-Sided | 80 | -1.05 | 5.98 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 253 | Mixed Models Analysis | 0.0708 | Treatment Effect | -3.64 | 2-Sided | 80 | -6.81 | -0.47 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 253 | Mixed Models Analysis | 0.5750 | Treatment Effect | 0.46 | 2-Sided | 80 | -2.67 | 3.59 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 253 | Mixed Models Analysis | 0.9560 | Treatment Effect | 4.10 | 2-Sided | 80 | 1.03 | 7.17 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 281 | Mixed Models Analysis | 0.1283 | Treatment Effect | -3.22 | 2-Sided | 80 | -6.86 | 0.42 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 281 | Mixed Models Analysis | 0.2085 | Treatment Effect | -2.28 | 2-Sided | 80 | -5.88 | 1.33 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 281 | Mixed Models Analysis | 0.6335 | Treatment Effect | 0.94 | 2-Sided | 80 | -2.61 | 4.49 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 309 | Mixed Models Analysis | 0.1778 | Treatment Effect | -2.64 | 2-Sided | 80 | -6.31 | 1.03 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 309 | Mixed Models Analysis | 0.4027 | Treatment Effect | -0.70 | 2-Sided | 80 | -4.33 | 2.94 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 309 | Mixed Models Analysis | 0.7570 | Treatment Effect | 1.94 | 2-Sided | 80 | -1.64 | 5.53 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 337 | Mixed Models Analysis | 0.1132 | Treatment Effect | -3.90 | 2-Sided | 80 | -8.03 | 0.23 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 337 | Mixed Models Analysis | 0.1965 | Treatment Effect | -2.71 | 2-Sided | 80 | -6.80 | 1.37 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
| Change from baseline at Day 337 | Mixed Models Analysis | 0.6471 | Treatment Effect | 1.18 | 2-Sided | 80 | -2.85 | 5.21 | Superiority | Least squares mean for change from baseline from repeated measures mixed effect model with treatment, visit and treatment*visit interaction, baseline lesion location (foveal vs. extrafoveal), baseline lesion type (unifocal vs. multifocal) and baseline value as fixed effects, and unstructured covariance for observations within the same subject. |
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