This trial has been terminated.

Condition neovascular age-related macular degeneration
Treatments regn2176-3, intravitreal aflibercept injection (iai)
Phase phase 2
Sponsor Regeneron Pharmaceuticals
Start date April 2015
End date August 2016
Trial size 505 participants
Trial identifier NCT02418754, NCT02603484, R2176-3-AMD-1417


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking participant, investigator, outcomes assessor
Group 1 will receive REGN2176-3 dosing regimen 1
Group 2 will receive REGN2176-3 dosing regimen 2
Group 3 will receive Intravitreal Aflibercept Injection (IAI) monotherapy
intravitreal aflibercept injection (iai) Eylea®

Primary Outcomes

Change in Best corrected visual acuity (BCVA)
time frame: Baseline at week 12

Secondary Outcomes

Change in central retinal lesion thickness as measured by 0ptical coherence tomography (OCT)
time frame: Baseline at week 12
Proportion of patients with complete resolution of intraretinal and subretinal fluid as measured by OCT
time frame: Baseline at week 12
Change in choroidal neovascularization (CNV) area as measured by Fluorescein angiography (FA)
time frame: Baseline at week 12
Change in lesion size as measured by Optical coherence tomography (OCT)
time frame: Baseline at week 12
Proportion of patients who gain ≥15 letters in BCVA as measured by 4-meter Early Treatment Diabetic Retinopathy Scale (ETDRS)
time frame: Baseline at week 12
Change in subretinal hyperreflectivity material (SHM) as measured by OCT
time frame: Baseline at week 12
Incidence of Treatment-emergent adverse event (TEAEs)
time frame: Baseline to week 12

Eligibility Criteria

All participants at least 50 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Regeneron Pharmaceuticals.