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)

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Neovascular Age-Related Macular Degeneration

Treatments: Drug: REGN910-3; Drug: Intravitreal Aflibercept Injection (IAI)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02713204

R910-3-AMD-1517

Details and patient eligibility

About

The primary objective of the study is to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).

Enrollment: 365 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. 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
2. BCVA ETDRS letter score of 73 to 24 (Snellen equivalent of 20/40 to 20/320) in the study eye.
3. Willing and able to comply with clinic visits and study-related procedures.
4. Provide signed informed consent.

Key Exclusion Criteria:

1. Evidence of CNV due to any cause other than AMD in either eye
2. Prior IVT anti-VEGF in the study eye
3. Evidence of DME or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients
4. Any history of macular hole of stage 2 and above in the study eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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365 participants in 3 patient groups

REGN910-3 (3 mg: 2 mg)

Experimental group

Description:

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.

Treatment:

Drug: REGN910-3

REGN910-3 (6 mg:2 mg)

Experimental group

Description:

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.

Treatment:

Drug: REGN910-3

Aflibercept (IAI) 2 mg

Experimental group

Description:

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.

Treatment:

Drug: Intravitreal Aflibercept Injection (IAI)

Drug: REGN910-3