Anti-angiOpoeitin 2 Plus Anti-vascular eNdothelial Growth Factor as a therapY for Neovascular Age Related Macular Degeneration: Evaluation of a fiXed Combination Intravitreal Injection (ONYX)
Neovascular Age-Related Macular Degeneration
About this trial
This is an interventional treatment trial for Neovascular Age-Related Macular Degeneration
Eligibility Criteria
Key Inclusion Criteria:
- Men or women ≥50 years of age with active subfoveal CNV secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye as assessed by a central reading center
- BCVA ETDRS letter score of 73 to 24 (Snellen equivalent of 20/40 to 20/320) in the study eye.
- Willing and able to comply with clinic visits and study-related procedures.
- Provide signed informed consent.
Key Exclusion Criteria:
- Evidence of CNV due to any cause other than AMD in either eye
- Prior IVT anti-VEGF in the study eye
- Evidence of DME or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients
- Any history of macular hole of stage 2 and above in the study eye
Sites / Locations
- Regeneron Investigational Site
- Regeneron Investigational Site 1
- Regeneron Investigational Site 2
- Regeneron Investigational Site 3
- Regeneron Investigational Site 1
- Regeneron Investigational Site 2
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site 1
- Regeneron Investigational Site 2
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site 1
- Regeneron Investigational Site 2
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site 1
- Regeneron Investigational Site 2
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site 1
- Regeneron Investigational Site 2
- Regeneron Investigational Site
- Regeneron Investigational Site 1
- Regeneron Investigational Site 2
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site 1
- Regeneron Investigational Site 2
- Regeneron Investigational Site
- Regeneron Investigational Site 1
- Regeneron Investigational Site 2
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
- Regeneron Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
REGN910-3 (3 mg: 2 mg)
REGN910-3 (6 mg:2 mg)
Aflibercept (IAI) 2 mg
Participants were administered intravitreal injection of REGN910-3 (3 milligram [mg]:2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 up to Week 32.
Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) Q8 or Q12 (beginning at Week 16 or Week 20) through Week 32.
Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI Q8 or Q12 (beginning at Week 16 or 20) or REGN910-3 (6 mg:2 mg) Q8 beginning at Week 16 through Week 32.