Phase 2
N=365
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
Neovascular Age-Related Macular Degeneration
Bottom Line
View on ClinicalTrials.gov: NCT02713204 ↗Enrolled (actual)
365
Serious AEs
16.3%
Results posted
May 2019
Primary outcome: Primary: Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 12 — 5.2; 5.6; 5.4 Letters correctly read — p=0.9894
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- REGN910-3 (Drug); Intravitreal Aflibercept Injection (IAI) (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 12 |
5.2; 5.6; 5.4 | 0.9894 |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 36 |
5.9; 6.0; 6.4; 6.9; 4.2; 2.9 | 0.4611 |
| SECONDARY Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 12 |
-182.2; -200.0; -178.6 | 0.4130 |
| SECONDARY Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 36 |
-174.6; -216.6; -181.3; -198.4; -169.7; -187.3 | 0.3833 |
| SECONDARY Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 12 |
-2.2; -3.5; -3.7 | 0.4889 |
| SECONDARY Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 36 |
-3.7; -4.1; -4.9; -4.3; -5.1; -5.3 | 0.4927 |
| SECONDARY Change From Baseline in Total Lesion Area at Week 12 |
-2.0; -3.5; -3.4 | 0.5065 |
| SECONDARY Change From Baseline in Total Lesion Area at Week 36 |
-3.0; -3.9; -4.7; -3.9; -4.7; -5.3 | 0.8383 |
Summary
The primary objective of the study is to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).
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
Data sourced from ClinicalTrials.gov (NCT02713204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.