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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002626-23 | EudraCT Number |
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This study was designed to evaluate the efficacy and safety of two different regimens of 0.5 mg ranibizumab given as intravitreal injection in patients with neovascular age-related macular degeneration
This was a 12-month, phase IIIb, randomized, Visual Acuity assessor-masked, multi-center, interventional study assessing the efficacy and safety of the TER vs monthly regimens of 0.5 mg ranibizumab intravitreal (IVT) injections in patients with newly diagnosed nAMD. Patients will be randomized 1:1 into one of two treatment arms, Treat and Extend or monthly regimens.
There will be 3 periods in this study: Screening period (up to 14days), treatment period (11 months), follow-up period (1 month). At randomization visit patients will be randomized into one of the 2 treatment groups Group I ranibizumab 0.5 mg based on monthly treatment or Group II ranibizumab 0.5 mg based on TER (randomization ratio of 1:1) and will receive the first dose of Investigational treatment. Patients in Group I the following visits will perform on monthly intervals. For patients in Group II the investigator will evaluate disease activity (i.e., signs of exudation) based on SD-OCT, and in case of absence of disease activity every next visit will be 2 weeks), with a maximum of a 12-week interval.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I ranibizumab 0.5 mg monthly | Active Comparator | Ranibizumab 0.5 mg/0.05 mL (Monthly regimen) up to month 11 |
|
| Group II ranibizumab 0.5 mg TER | Active Comparator | Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen up to month 11 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab 0.5mg | Drug | 0.5 mg ranibizumab (intravitreal injections) prefilled syringe) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement | Baseline to month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Visits Scheduled | The number of visits scheduled according to the treat and extend regimen after treatment initiation | From Month1 to Month 11 |
| Change in BCVA From Baseline to Month 12 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Antwerp | 2020 | Belgium | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34934034 | Derived | Pawloff M, Bogunovic H, Gruber A, Michl M, Riedl S, Schmidt-Erfurth U. SYSTEMATIC CORRELATION OF CENTRAL SUBFIELD THICKNESS WITH RETINAL FLUID VOLUMES QUANTIFIED BY DEEP LEARNING IN THE MAJOR EXUDATIVE MACULAR DISEASES. Retina. 2022 May 1;42(5):831-841. doi: 10.1097/IAE.0000000000003385. | |
| 32374423 | Derived |
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Patients were randomized 1:1 into one of two treatment arms, Treat and Extend or monthly regimens.
Safety set: One patient was randomized but did not receive at least one study treatment and did not record at least one post-baseline safety assessment
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I Ranibizumab 0.5 mg TER | Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen |
| FG001 | Group II Ranibizumab 0.5 mg Monthly | Ranibizumab 0.5 mg/0.05 mL (Monthly regimen) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Ranibizumab 0.5mg | Drug | 0.5 mg ranibizumab (intravitreal injections) prefilled syringe) |
|
|
Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters
| Baseline to Month 12 |
| Average BCVA Change From Baseline to Month 12 | Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from Baseline to Month 12 | Baseline and every month for 12 months |
| Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and compare to Baseline | Baseline and every month for 12 months |
| Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 12 as compared with baseline | Baseline and every month for 12 months |
| Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. | Baseline and every month for 12 months |
| Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 12 indicates a positive outcome | Baseline and every month for 12 months |
| The Mean Number of Treatment Frequency | The number of injections received | Month 12 |
| The Average Number of Days Between Injections | The average dosing interval was measured as the average number of days between injections | Month 12 |
| Percentage of Participants With Fluid Free Macula Over Time up to Month 12 | OCT (optical coherence tomography) was used to assess intra-retinal fluid as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography). Fluid free macula refers to absence of macular edema (as assessed by the reading center). The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the macular edema (center involvement) at study completion. These total counts are used as the denominator for the percentages | Month 12 |
| Change in Central Subfield Retinal Thickness (CSFT) Over Time | OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center. The Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit | Month 12 |
| Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at | To evaluate presence of active CNV leakage on fluorescein angiography (FA) by reading center over time up to Month 12. The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the presence of leakage at study completion. These total counts are used as the denominator for the percentages. | Month 12 |
| Change From Baseline in Composite Score of the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) | The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicates the best possible response. The composite score and score of each of each construct also ranged from 0 to 100 as they are calculated as total scores divided by the number of questions. The higher the values of total scores represent better outcome | Baseline, Month 12 |
| Ottignies |
| 1340 |
| Belgium |
| Novartis Investigative Site | Zottegem | 9620 | Belgium |
| Novartis Investigative Site | Santiago | 7650018 | Chile |
| Novartis Investigative Site | Zagreb | Croatia | 10000 | Croatia |
| Novartis Investigative Site | Glostrup Municipality | 2600 | Denmark |
| Novartis Investigative Site | Roskilde | 4000 | Denmark |
| Novartis Investigative Site | Cairo | Abbassia | Egypt |
| Novartis Investigative Site | Cairo | Egypt |
| Novartis Investigative Site | Leipzig | Germany | 04103 | Germany |
| Novartis Investigative Site | Ahaus | 48683 | Germany |
| Novartis Investigative Site | Augsburg | 86156 | Germany |
| Novartis Investigative Site | Chemnitz | 09113 | Germany |
| Novartis Investigative Site | Cologne | 50935 | Germany |
| Novartis Investigative Site | Darmstadt | 64297 | Germany |
| Novartis Investigative Site | Göttingen | 37075 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Karlsruhe | 76199 | Germany |
| Novartis Investigative Site | Ludwigshafen | 67063 | Germany |
| Novartis Investigative Site | Magdeburg | 39120 | Germany |
| Novartis Investigative Site | Münster | 48145 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| Novartis Investigative Site | Siegburg | 53721 | Germany |
| Novartis Investigative Site | Stuttgart | 70174 | Germany |
| Novartis Investigative Site | Sulzbach | 66280 | Germany |
| Novartis Investigative Site | Budapest | 1076 | Hungary |
| Novartis Investigative Site | Budapest | 1083 | Hungary |
| Novartis Investigative Site | Budapest | 1106 | Hungary |
| Novartis Investigative Site | Budapest | 1133 | Hungary |
| Novartis Investigative Site | Budapest | 1145 | Hungary |
| Novartis Investigative Site | Budapest | H-1115 | Hungary |
| Novartis Investigative Site | Debrecen | 4012 | Hungary |
| Novartis Investigative Site | Pécs | 7624 | Hungary |
| Novartis Investigative Site | Szeged | H-6725 | Hungary |
| Novartis Investigative Site | Zalaegerszeg | 8900 | Hungary |
| Novartis Investigative Site | Bangalore | Karnataka | 560010 | India |
| Novartis Investigative Site | Chennai | Tamil Nadu | 600 006 | India |
| Novartis Investigative Site | Vanchiyoor | Thiruvanantapuram | 695035 | India |
| Novartis Investigative Site | Haifa | 3525408 | Israel |
| Novartis Investigative Site | Jerusalem | 9112001 | Israel |
| Novartis Investigative Site | Petah Tikva | 49100 | Israel |
| Novartis Investigative Site | Rehovot | 76100 | Israel |
| Novartis Investigative Site | Tel Aviv | 6423906 | Israel |
| Novartis Investigative Site | Florence | FI | 50134 | Italy |
| Novartis Investigative Site | Milan | MI | 20100 | Italy |
| Novartis Investigative Site | Milan | MI | 20132 | Italy |
| Novartis Investigative Site | Padova | PD | 35128 | Italy |
| Novartis Investigative Site | Pisa | PI | 56124 | Italy |
| Novartis Investigative Site | Roma | RM | 00198 | Italy |
| Novartis Investigative Site | Sassari | SS | 07100 | Italy |
| Novartis Investigative Site | Udine | UD | 33100 | Italy |
| Novartis Investigative Site | Coimbra | Portugal | 3000-354 | Portugal |
| Novartis Investigative Site | Coimbra | Portugal | 3030-163 | Portugal |
| Novartis Investigative Site | Lisbon | Portugal | 1150-314 | Portugal |
| Novartis Investigative Site | Porto | Portugal | 4099-001 | Portugal |
| Novartis Investigative Site | Vila Franca de Xira | Portugal | 2600-009 | Portugal |
| Novartis Investigative Site | Kazan' | 420012 | Russia |
| Novartis Investigative Site | Moscow | 119021 | Russia |
| Novartis Investigative Site | Moscow | 127486 | Russia |
| Novartis Investigative Site | Novosibirsk | 630071 | Russia |
| Novartis Investigative Site | Samara | 443068 | Russia |
| Novartis Investigative Site | Banská Bystrica | Slovakia | 97517 | Slovakia |
| Novartis Investigative Site | Nové Zámky | Slovakia | 94001 | Slovakia |
| Novartis Investigative Site | Poprad | Slovakia | 05845 | Slovakia |
| Novartis Investigative Site | Žilina | Slovakia | 01207 | Slovakia |
| Novartis Investigative Site | Bratislava | 82606 | Slovakia |
| Novartis Investigative Site | Ljubljana | Slovenia | 1000 | Slovenia |
| Novartis Investigative Site | Busan | Busan | 49241 | South Korea |
| Novartis Investigative Site | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 03080 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 06591 | South Korea |
| Novartis Investigative Site | Barcelona | Barcelona | 08025 | Spain |
| Novartis Investigative Site | Valladolid | Castille and León | 47011 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08022 | Spain |
| Novartis Investigative Site | Sant Cugat del Vallès | Catalonia | 08190 | Spain |
| Novartis Investigative Site | Oviedo | Principality of Asturias | 33012 | Spain |
| Novartis Investigative Site | Zaragoza | Zaragoza | 50009 | Spain |
| Novartis Investigative Site | Bern | 3010 | Switzerland |
| Novartis Investigative Site | Bern | 3012 | Switzerland |
| Novartis Investigative Site | Lausanne | 1007 | Switzerland |
| Novartis Investigative Site | Zurich | 8063 | Switzerland |
| Novartis Investigative Site | Ankara | Turkey | 06490 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Uxbridge | London | UB8 3NN | United Kingdom |
| Novartis Investigative Site | Frimley | Surrey | GU16 7UJ | United Kingdom |
| Novartis Investigative Site | Belfast | BT12 6BA | United Kingdom |
| Novartis Investigative Site | Bristol | BS1 2LX | United Kingdom |
| Novartis Investigative Site | Guildford, Surrey | GU2 5XX | United Kingdom |
| Novartis Investigative Site | London | EC1V 2PD | United Kingdom |
| Novartis Investigative Site | Manchester | M13 9WL | United Kingdom |
| Novartis Investigative Site | Sunderland | SR2 9HP | United Kingdom |
| Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2. |
| 31563866 | Derived | Waldstein SM, Coulibaly L, Riedl S, Sadeghipour A, Gerendas BS, Schmidt-Erfurth UM. Effect of posterior vitreous detachment on treat-and-extend versus monthly ranibizumab for neovascular age-related macular degeneration. Br J Ophthalmol. 2020 Jul;104(7):899-903. doi: 10.1136/bjophthalmol-2019-314661. Epub 2019 Sep 28. |
| Safety Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group I Ranibizumab 0.5 mg TER | Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen |
| BG001 | Group II Ranibizumab 0.5 mg Monthly | Ranibizumab 0.5 mg/0.05 mL (Monthly regimen) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement | The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and study completion after last observational carried forward (LOCF) were included in this analysis. LOCF was used as an imputation of missing data. | Posted | Least Squares Mean | Standard Error | Letters (EDTRS) | Baseline to month 12 |
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| Secondary | Number of Visits Scheduled | The number of visits scheduled according to the treat and extend regimen after treatment initiation | The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was analyzed. | Posted | Mean | Standard Deviation | Number of visits | From Month1 to Month 11 |
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| Secondary | Change in BCVA From Baseline to Month 12 | Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters | The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and study completion after last observational carried forward (LOCF) were included in this analysis. LOCF was used as an imputation of missing data. | Posted | Mean | Standard Deviation | Letters (EDTRS) | Baseline to Month 12 |
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| Secondary | Average BCVA Change From Baseline to Month 12 | Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from Baseline to Month 12 | The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and average visual acuity (VA) from month 1 to study completion were included in this analysis. | Posted | Mean | Standard Deviation | Letters (EDTRS) | Baseline and every month for 12 months |
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| Secondary | Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 | Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) -like charts while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. For the mean change of best corrected visual acuity at Month 12 and compare to Baseline | The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit. | Posted | Mean | Standard Deviation | Letters (EDTRS) | Baseline and every month for 12 months |
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| Secondary | Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 | BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters of visual acuity at Month 12 as compared with baseline | The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis. | Posted | Number | Number of participants | Baseline and every month for 12 months |
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| Secondary | Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit | Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. | The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis. | Posted | Number | Number of participants | Baseline and every month for 12 months |
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| Secondary | Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 | Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at Month 12 indicates a positive outcome | The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis. | Posted | Number | Number of participants | Baseline and every month for 12 months |
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| Secondary | The Mean Number of Treatment Frequency | The number of injections received | Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization | Posted | Mean | Standard Deviation | Number of injections | Month 12 |
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| Secondary | The Average Number of Days Between Injections | The average dosing interval was measured as the average number of days between injections | Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization | Posted | Mean | Standard Deviation | days | Month 12 |
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| Secondary | Percentage of Participants With Fluid Free Macula Over Time up to Month 12 | OCT (optical coherence tomography) was used to assess intra-retinal fluid as Measured by SD-OCT (Spectral Domain-Optical Coherence Tomography). Fluid free macula refers to absence of macular edema (as assessed by the reading center). The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the macular edema (center involvement) at study completion. These total counts are used as the denominator for the percentages | Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization | Posted | Number | Percentage of participants | Month 12 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Central Subfield Retinal Thickness (CSFT) Over Time | OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center. The Ns in the rows is the number of patients with a value for both baseline and the specific post-baseline visit | The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and the specific post-baseline visit were included for this analysis. | Posted | Mean | Standard Deviation | microns | Month 12 |
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| Secondary | Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at | To evaluate presence of active CNV leakage on fluorescein angiography (FA) by reading center over time up to Month 12. The full analysis set was used for this evaluation but the count presented are the counts of patients in the specific treatment group who have a value for the presence of leakage at study completion. These total counts are used as the denominator for the percentages. | Full Analysis Set (FAS) comprised all patients to whom treatment regimen had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment regimen they were assigned to at randomization. | Posted | Number | Percentage of participants | Month 12 |
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| Secondary | Change From Baseline in Composite Score of the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) | The survey consisted of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranged from 0 (worst) to 100 which indicates the best possible response. The composite score and score of each of each construct also ranged from 0 to 100 as they are calculated as total scores divided by the number of questions. The higher the values of total scores represent better outcome | The Full Analysis Set (FAS), comprised of all patients to whom treatment regimen had been assigned, was considered for the analysis. Only patients with the value for both Baseline and post-baseline value at the specific visit were included for this analysis | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Month 12 |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I Ranibizumab 0.5 mg TER | Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen | 39 | 323 | 164 | 323 | ||
| EG001 | Group II Ranibizumab 0.5 mg Monthly | Ranibizumab 0.5 mg/0.05 mL (Monthly regimen) | 42 | 326 | 166 | 326 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cataract (Fellow eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Corneal erosion (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Corneal infiltrates (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dacryostenosis acquired (Fellow eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dacryostenosis acquired (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Macular hole (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Retinal detachment (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Retinal haemorrhage (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Retinal tear (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vitreous haemorrhage (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis chronic | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatic cirrhosis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Endophthalmitis (Fellow eye) | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Endophthalmitis (Study eye) | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways disease | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Intraocular pressure increased (Fellow eye) | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Intraocular pressure increased (Study eye) | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypercreatininaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Gastrointestinal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Non-small cell lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Carotid artery thrombosis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| VIth nerve paresis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bladder prolapse | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Age-related macular degeneration (Fellow eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Blepharitis (Fellow eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Blepharitis (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cataract (Fellow eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cataract (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Choroidal neovascularisation (Fellow eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Detachment of retinal pigment epithelium (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dry eye (Fellow eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dry eye (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Eye pain (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neovascular age-related macular degeneration (Fellow eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ocular hypertension (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Punctate keratitis (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Retinal haemorrhage (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Retinal pigment epithelial tear (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Visual acuity reduced (Fellow eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Visual acuity reduced (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vitreous floaters (Study eye) | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Conjunctivitis (Fellow eye) | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Conjunctivitis (Study eye) | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Intraocular pressure increased (Fellow eye) | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Intraocular pressure increased (Study eye) | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | trialandresults.registries@novartis.com |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
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| Units | Counts |
|---|---|
| Participants |
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