Study of Intravitreal REGN2176-3 in Patients With Neovascular ("Wet") Age-Related Macular Degeneration (AMD)



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:4/21/2016
Start Date:April 2015
End Date:April 2017
Contact:Clinical Trials Administrator
Email:clinicaltrials@regeneron.com

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A Phase 2, Double-Masked, Randomized, Controlled, Multiple-Dose, Regimen-Ranging Study of the Efficacy and Safety of Intravitreal REGN2176-3 in Patients With Neovascular Age-Related Macular Degeneration

The primary objective of the study is to explore the effect of REGN2176-3 on the Early
Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in patients
with neovascular age-related macular degeneration (AMD), compared to intravitreal
aflibercept injection (IAI) monotherapy.


Key Inclusion Criteria:

1. Men or women ≥50 years of age

2. Active subfoveal CNV secondary to AMD as evidenced by FA in the study eye, as
determined by the reading center, including juxtafoveal lesions that affect the fovea

3. BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye at the
screening visit

4. Provide signed informed consent

Key Exclusion Criteria:

1. Any prior treatment with anti-VEGF treatment in the study eye

2. Any prior treatment (ie, systemic or ocular treatment) with PDGF or PDGFR inhibitors

3. Dense fibrotic scar 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. Evidence of diabetic retinopathy or diabetic macular edema in either eye

10. Positive serum human chorionic gonadotropin/urine pregnancy test at the screening or
baseline visit
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