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The purpose of this study is to evaluate the safety, tolerability, and serum pharmacokinetics of CLG561 in subjects with advanced age-related macular degeneration (AMD).
Subjects were divided into 5 cohorts, with the subjects in each cohort being administered a single IVT dose of CLG561 in 1 of 5 concentration levels A-E, where A=lowest and E=highest. All subjects received active CLG561. Progress from one cohort to the next was time-lagged to allow for safety review. Dosing was also time-lagged within each cohort. Only one eye (designated as the study eye) was dosed per subject. Post-dose safety assessments and ocular examination occurred immediately after the IVT injection and continued throughout the outpatient visits at pre-determined timepoints. Collection of post-injection blood samples began after the IVT injection at pre-determined timepoints. Subjects were followed for up to 84 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLG561, Concentration Level A | Experimental | Single 50 μL intravitreal injection of CLG561, Dose Level A |
|
| CLG561, Concentration Level B | Experimental | Single 50 μL intravitreal injection of CLG561, Dose Level B |
|
| CLG561, Concentration Level C | Experimental | Single 50 μL intravitreal injection of CLG561, Dose Level C |
|
| CLG561, Concentration Level D | Experimental | Single 50 μL intravitreal injection of CLG561, Dose Level D |
|
| CLG561, Concentration Level E | Experimental | Single 100 μL intravitreal injection of CLG561, Dose Level E |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLG561 | Drug | Administered by intravitreal injection, Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye | BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis. | Baseline, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85 |
| Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye | IOP was measured by Goldmann applanation tonometry or tonopen, at the discretion of the Investigator, and reported in mmHg (millimeters of mercury). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. | Baseline, Day 1, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85 |
| Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment | A dilated fundus examination was performed to evaluate the health of the retina, macula, choroid, and optic nerve. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication. | Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85 |
| Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment | A slit-lamp biomicroscopy examination was performed to evaluate the anterior segment of the eye. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Serum Concentration-time Curve (AUC) From Time Zero to All [AUC(0-all)] | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method. | Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Head of Clinical Sciences, CA CSI NS/Opth | Alcon Research | Study Director |
Not provided
Of the 50 enrolled,19 subjects were exited as screen failures prior to randomization. This reporting group includes all assigned subjects (31).
Subjects were recruited from 4 investigational centers located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | CLG561, Level A | Single 50 μL intravitreal injection of CLG561, Dose Level A |
| FG001 | CLG561, Level B | Single 50 μL intravitreal injection of CLG561, Dose Level B |
| FG002 | CLG561, Level C | Single 50 μL intravitreal injection of CLG561, Dose Level C |
| FG003 | CLG561, Level D | Single 50 μL intravitreal injection of CLG561, Dose Level D |
| FG004 | CLG561, Level E | Single 100 μL intravitreal injection of CLG561, Dose Level E |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This analysis population includes all enrolled subjects who received CLG561.
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| ID | Title | Description |
|---|---|---|
| BG000 | CLG561, Level A | Single 50 μL intravitreal injection of CLG561, Dose Level A |
| BG001 | CLG561, Level B | Single 50 μL intravitreal injection of CLG561, Dose Level B |
| 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 | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye | BCVA (with spectacles or other visual corrective devices) using Early Treatment Diabetic Retinopathy Study (ETDRS) testing was reported in letters read correctly. Improvement of BCVA was defined as an increase (gain) in letters read from the baseline assessment. One eye (study eye) contributed to the analysis. | This analysis population includes all enrolled subjects who received investigational product. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively. | Posted | Mean | Standard Deviation | letters | Baseline, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85 |
|
Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 84 days). Ocular AEs are presented for both study eye and non-study eye. AEs were obtained as solicited comments and observations by the Investigator.
An AE was defined as any untoward medical occurrence in a subject exposed to study drug or any unfavorable and unintended sign, symptom, or disease temporally associated with use of study drug, or untoward medical occurrence at any time prior to administration of first dose of study drug. AEs were reported as pre-treatment and treatment-emergent.
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 | CLG561, Level A | Reported subsequent to the initiation of treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blindness Transient | Eye disorders | MedDRA (15.0) | Systematic Assessment | Study Eye.Transient blindness was due to transient rise in intraocular pressure. Visual acuity returned to pre-injection levels after a paracentesis was performed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Translational Medicine Expert, Ophthalmology | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057092 | Geographic Atrophy |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
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| Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85 |
| Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)] | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method. | Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85 |
| Time to Reach the Maximum Serum Concentration After Drug Administration (Tmax) | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method. | Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85 |
| Dose Normalized Observed Maximum Serum Concentration Following Drug Administration (Cmax/D) | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method. | Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85 |
| Dose-normalized Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)/D] | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method. | Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85 |
| Area Under the Serum Concentration-time Curve From Time Zero to Time "t" Where t is a Defined Time Point After Administration [AUC(0-t)] | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. | Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85 |
| Terminal Elimination Half-life (T½) | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. | Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85 |
| The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. | Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85 |
| Apparent Systemic (or Total Body) Clearance From Serum Following Extravascular Administration (CL/F) | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. | Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85 |
| BG002 | CLG561, Level C | Single 50 μL intravitreal injection of CLG561, Dose Level C |
| BG003 | CLG561, Level D | Single 50 μL intravitreal injection of CLG561, Dose Level D |
| BG004 | CLG561, Level E | Single 100 μL intravitreal injection of CLG561, Dose Level E |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Primary Diagnosis | Geographic atrophy was classified as atrophic lesions in the macula related to AMD as assessed by Fundus autofluorescence. Exudative (wet) macular degeneration was classified as patients suffering from neovascular (wet) AMD, as assessed by fluorescein angiography, who were not likely to require anti-VEGF (vascular endothelial growth factor) therapy during the study period. | Number | participants |
|
| OG001 |
| CLG561, Level B |
Single 50 μL intravitreal injection of CLG561, Dose Level B |
| OG002 | CLG561, Level C | Single 50 μL intravitreal injection of CLG561, Dose Level C |
| OG003 | CLG561, Level D | Single 50 μL intravitreal injection of CLG561, Dose Level D |
| OG004 | CLG561, Level E | Single 100 μL intravitreal injection of CLG561, Dose Level E |
|
|
| Primary | Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye | IOP was measured by Goldmann applanation tonometry or tonopen, at the discretion of the Investigator, and reported in mmHg (millimeters of mercury). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye (study eye) contributed to the analysis. | This analysis population includes all enrolled subjects who received investigational product. Here, "n" is the number of subjects with non-missing values at the specific time point for each arm group, respectively. | Posted | Mean | Standard Deviation | mmHg | Baseline, Day 1, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85 |
|
|
|
| Primary | Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment | A dilated fundus examination was performed to evaluate the health of the retina, macula, choroid, and optic nerve. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication. | This analysis population includes all enrolled subjects who received investigational product. | Posted | Number | participants | Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85 |
|
|
|
| Primary | Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment | A slit-lamp biomicroscopy examination was performed to evaluate the anterior segment of the eye. Subjects having a normal baseline evaluation were examined at subsequent visits, and any change from normal to abnormal was recorded. Criteria for reclassifying from normal to abnormal were left to the opinion of the investigators. One eye (study eye) contributed to the analysis. None of the abnormalities were deemed related to the study medication. | This analysis population includes all enrolled subjects who received investigational product. | Posted | Number | participants | Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85 |
|
|
|
| Secondary | Area Under the Serum Concentration-time Curve (AUC) From Time Zero to All [AUC(0-all)] | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method. | This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred. | Posted | Mean | Standard Deviation | hr*ng/mL | Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85 |
|
|
|
| Secondary | Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)] | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method. | This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred. | Posted | Mean | Standard Deviation | hr*ng/mL | Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85 |
|
|
|
| Secondary | Time to Reach the Maximum Serum Concentration After Drug Administration (Tmax) | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method. | This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred. | Posted | Mean | Standard Deviation | hours | Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85 |
|
|
|
| Secondary | Dose Normalized Observed Maximum Serum Concentration Following Drug Administration (Cmax/D) | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method. | This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred. | Posted | Mean | Standard Deviation | ng/mL/mg | Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85 |
|
|
|
| Secondary | Dose-normalized Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-last)/D] | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental PK method. | This analysis population includes all subjects who received investigational product, completed at least 1 post-injection study visit and for whom serum concentration-time data is available, provided no collection or analytical deviations which would affect the integrity of the data occurred. | Posted | Mean | Standard Deviation | hr*ng/mL/mg | Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85 |
|
|
|
| Secondary | Area Under the Serum Concentration-time Curve From Time Zero to Time "t" Where t is a Defined Time Point After Administration [AUC(0-t)] | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. | This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561. | Posted | Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85 |
|
|
| Secondary | Terminal Elimination Half-life (T½) | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. | This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561. | Posted | Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85 |
|
|
| Secondary | The Apparent Volume of Distribution During the Terminal Elimination Phase Following Extravascular Administration (Vz/F) | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. | This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561. | Posted | Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85 |
|
|
| Secondary | Apparent Systemic (or Total Body) Clearance From Serum Following Extravascular Administration (CL/F) | Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. | This parameter was not calculated as AUClast and AUCall were considered sufficient to characterize the systemic exposure to CLG561. | Posted | Day 1 pre-injection, 2h, 6h, Day 2, Day 4, Day 6, Day 8, Day 11, Day 15, Day 29, Day 57, Day 85 |
|
|
| 1 |
| 6 |
| 5 |
| 6 |
| EG001 | CLG561, Level B | Reported subsequent to the initiation of treatment | 0 | 6 | 3 | 6 |
| EG002 | CLG561, Level C | Reported subsequent to the initiation of treatment | 1 | 7 | 6 | 7 |
| EG003 | CLG561, Level D | Reported subsequent to the initiation of treatment | 0 | 6 | 2 | 6 |
| EG004 | CLG561, Level E | Reported subsequent to the initiation of treatment | 0 | 6 | 3 | 6 |
| EG005 | Pretreatment | Reported prior to the initiation of study treatment | 0 | 50 | 0 | 50 |
|
| Angina pectoris | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Heart valve incompetence | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (15.0) | Systematic Assessment |
|
| Arcus lipoides | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Conjunctivochalasis | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Erythema of eyelid | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Eye discharge | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Eyelid cyst | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Eyelid margin crusting | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Foreign body sensation in eyes | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Lacrimal disorder | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Optic atrophy | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Optic disc disorder | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vitreal cells | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vitreous degeneration | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vitreous floaters | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Vitreous opacities | Eye disorders | MedDRA (15.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (15.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (15.0) | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Crystal urine present | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA (15.0) | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (15.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
|
| Cutis laxa | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Madarosis | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Seborrhoea | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (15.0) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
| D014603 |
| Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Day 1, n=6,6,7,6,6 |
|
| Day 2, n=6,6,7,6,6 |
|
| Day 4, n=6,6,7,6,6 |
|
| Day 15, n=6,6,6,6,6 |
|
| Day 29, n=6,5,6,6,6 |
|
| Day 57, n=6,5,6,6,6 |
|
| Day 85, n=6,6,6,6,6 |
|
| Retina: Change from Normal to Abnormal |
|
| Macula: Baseline Normal |
|
| Macula: Change from Normal to Abnormal |
|
| Choroid: Baseline Normal |
|
| Choroid: Change from Normal to Abnormal |
|
| Optic Nerve: Baseline Normal |
|
| Optic Nerve: Change from Normal to Abnormal |
|
| Lids/Lashes: Change from Normal to Abnormal |
|
| Conjunctiva: Baseline Normal |
|
| Conjunctiva: Change from Normal to Abnormal |
|
| Cornea: Baseline Normal |
|
| Cornea: Change from Normal to Abnormal |
|
| Iris: Baseline Normal |
|
| Iris: Change from Normal to Abnormal |
|