Neovascular Age-related Macular Degeneration
Conditions
Interventions
investigational material(s)
Generic name etc : ABP 938
INN of investigational material : -
Therapeutic category code : 131 Agents for ophthalmic use
Dosage and Administration for Investigational mater
Sponsors
Amgen, Inc. (ICCC: PAREXEL International)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must sign an Institutional Review Board/Independent Ethics Committee approved informed consent form before any study-specific procedures 2. Men or women >= 50 years old 3. Subjects must be diagnosed with neovascular (wet) AMD in the study eye (confirmed by central imaging vendor before randomization) 4. Active treatment naive CNV lesions secondary to neovascular (wet) AMD as confirmed with SD-OCT, FA and FP in the study eye (confirmed by central imaging vendor before randomization) 5. BCVA between 73 and 34 letters, inclusive, in the study eye using ETDRS test AND >34 letters in the fellow eye. 6. Presence of intra and/or subretinal fluid as identified by SD-OCT attributable to active CNV in the study eye (confirmed by central imaging vendor before randomization) 7. Central retinal thickness of >= 300 microm in the study eye as determined by SD-OCT at screening (confirmed by central imaging vendor before randomization)
Exclusion criteria
Exclusion criteria: Eye Related Subjects are excluded if they meet any of the following criteria in the study eye: 1. Total lesion size > 9 disc areas (22.86mm2, including blood, scars, and neovascularization) in the study eye (confirmed by central imaging vendor before randomization) 2. Active CNV area (classic plus occult components) that is = 25 mmHg despite treatment with antiglaucoma medication) in the study eye 14. Aphakia or pseudophakia with complete absence of posterior capsule (unless it occurred as a result of a yttrium aluminum garnet [YAG] posterior capsulotomy) in the study eye 15. Previous therapeutic radiation in the region of the study eye 16. History of corneal transplant or corneal dystrophy in the study eye 17. Significant media opacities, including cataract, which might interfere with visual acuity or assessment of safety, in the study eye 18. Any concurrent intraocular condition other than neovascular (wet) AMD in the study eye that, in the opinion of the investigator, requires planned medical or surgical intervention during the study or increases the risk to the subject beyond what is expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety Subjects are excluded if they meet any of the following criteria in either eye: 19. History or clinical evidence of uveitis, diabetic retinopathy, diabetic macular edema, or any other vascular disease affecting the retina, other than neovascular (wet) AMD (confirmed by central imaging vendor before randomization) 20. Active intraocular inflammation or active or suspected ocular or periocular infection, within 2 weeks before randomization 21. Active scleritis or episcleritis or presence of scleromalacia Other Med
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Change from baseline in best corrected visual acuity (BCVA) as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy -Proportion of subjects who maintained vision at week 52, where a subject was classified as maintaining vision if he/she lost fewer than 15 letters in ETDRS letter score compared to baseline -Change from baseline in BCVA as measured by ETDRS letter score over the study duration -Proportion of subjects who gained at least 10 letters of vision at week 8 and proportion of subjects who gained at least 15 letters of vision at week 52 as compared to baseline -Change from baseline in choroidal neovascularization (CNV) area and central subfield thickness (CST) as measured by fluorescein angiography (FA) and spectral domain optical coherence tomography (SD-OCT) over the study duration -Treatment-emergent adverse events, adverse events of interest (EOIs), and serious adverse events -Incidence of antidrug antibodies (ADA) | — |
Countries
Asia except Japan, Europe, Japan, North America
Outcome results
None listed