Phase 2
N=302
Anti-vasculaR Endothelial Growth Factor plUs Anti-angiopoietin 2 in Fixed comBination therapY: Evaluation for the Treatment of Diabetic Macular Edema
Diabetic Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT02712008 ↗Enrolled (actual)
302
Serious AEs
18.2%
Results posted
Oct 2018
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 — 6.8; 8.5; 8.8 Letters correctly read — p=0.1368
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- REGN910-3 (Drug); Intravitreal Aflibercept Injection (IAI) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Jul 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 |
6.8; 8.5; 8.8 | 0.1368 |
| PRIMARY Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 36 |
9.8; 10.3; 8.5; 8.7; 10.0; 11.9 | 0.1665 |
| SECONDARY Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 12 |
-169.4; -184.0; -174.6 | 0.1105 |
| SECONDARY Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 36 |
-210.4; -223.4; -193.7; -161.9; -210.6; -203.7 | 0.0040 sig |
| SECONDARY Percentage of Participants With a ≥ 2-step Improvement at Week 12 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline |
13.3; 21.3; 15.2 | 0.7617 |
| SECONDARY Percentage of Participants With a ≥ 2-step Improvement at Week 36 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline |
26.7; 34.1; 34.0; 26.1; 25.5; 35.4 | 0.8896 |
Summary
The primary objective of the study was to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI) in improving best corrected visual acuity (BCVA) in participants with diabetic macular edema (DME).
Eligibility Criteria
Key Inclusion Criteria
- Men or women ≥18 years of age with type 1 or type 2 diabetes mellitus who have clinically significant DME with central involvement in the study eye
- 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 macular edema due to any cause other than diabetes mellitus in either eye
- IVT anti-VEGF in the study eye within 12 weeks of the screening visit
- Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
Note: Other inclusion/ exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT02712008). 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.