Phase 2 Completed N=302 Randomized Quadruple-blind Treatment

Anti-vasculaR Endothelial Growth Factor plUs Anti-angiopoietin 2 in Fixed comBination therapY: Evaluation for the Treatment of Diabetic Macular Edema

Diabetic Macular Edema

Source: ClinicalTrials.gov NCT02712008 ↗

Enrolled (actual)

302

Serious AEs

18.2%

Results posted

Oct 2018

Primary outcomePrimary: 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

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).

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.