Neovascular Wet Age-related Macular Degeneration (AMD)
Conditions
Brief summary
The primary objective of the study is to investigate the safety of intravitreal (IVT) REGN2176-3 in patients with neovascular wet age-related macular degeneration (AMD).
Interventions
DRUGREGN2176-3
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Criteria: Men or women greater than or equal to 50 years of age who provide informed consent and have active subfoveal choroidal neovascularization (CNV) secondary to wet AMD.
Exclusion criteria
1. Any prior treatment with an inhibitor of PDGF (platelet-derived growth factor) or PDGFR (platelet-derived growth factor receptor) 2. Active neovascular AMD in the fellow eye requiring treatment 3. Scar, fibrosis, or atrophy in the study eye involving the center of the fovea 4. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye 5. Prior vitrectomy in the study eye 6. Any history of macular hole of stage 2 and above in the study eye 7. Any intraocular or periocular surgery within 3 months of day 1 in the study eye, except lid surgery 8. History of corneal transplant in the study eye 9. Positive serum human chorionic gonadotropin (hCG)/ urine pregnancy test at the screening or baseline visit The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial and not all inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | day 1 through week 24 | The primary endpoint in the study is the incidence of treatment emergent adverse events (TEAEs) from day 1 through week 24 in patients treated with IVT REGN2176-3. |
Countries
United States
Outcome results
None listed