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
CompletedPhase 2Results postedLast updated 7 May 2019
What this trial tests
Phase 2 trial testing REGN910-3 in Neovascular Age-Related Macular Degeneration in 365 participants. Completed in 3 October 2017.
50 and older, any sex, with Neovascular Age-Related Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 12Primary· At Week 12
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. Best Corrected Visual Acuity (BCVA) score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracti
Group
Value
95% CI
REGN910-3 (3 mg:2 mg)
5.2
± 10.51
REGN910-3 (6 mg:2 mg)
5.6
± 10.59
Aflibercept (IAI) 2 mg
5.4
± 9.85
Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 36Primary· At Week 36
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. BCVA score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed
Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 12Secondary· At Week 12
Central Sub-field Retinal Thickness (CST) was assessed using Spectral Domain Optical Coherence Tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from last observation carried forward (LOCF) post-baseline value at Week 12.
Group
Value
95% CI
REGN910-3 (3 mg:2 mg)
-182.2
± 172.73
REGN910-3 (6 mg:2 mg)
-200.0
± 152.82
Aflibercept (IAI) 2 mg
-178.6
± 138.85
Change From Baseline in Central Sub-field Retinal Thickness (CST) Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) at Week 36Secondary· At Week 36
CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from LOCF post-baseline value at Week 36.
Change From Baseline in Total Lesion Area at Week 12Secondary· At Week 12
Total lesion area was evaluated using fluorescein angiography (FA). Lesion area values measured in square millimeters (mm\^2); lower values represent better outcomes.
Group
Value
95% CI
REGN910-3 (3 mg:2 mg)
-2.0
± 6.10
REGN910-3 (6 mg:2 mg)
-3.5
± 5.45
Aflibercept (IAI) 2 mg
-3.4
± 6.48
Change From Baseline in Total Lesion Area at Week 36Secondary· At Week 36
Total lesion area was evaluated using fluorescein angiography (FA). Lesion area values measured in square millimeters (mm\^2); lower values represent better outcomes.
Proportion of Participants With No Retinal and/or Subretinal Fluid at Week 12Secondary· At Week 12
Retinal and/or subretinal fluid was assessed using intraretinal fluid (IRF) cystoid edema and subretinal fluid (SRF) in the center subfield on optical coherence tomography (OCT). If answers were "no" to both measurements, there was no retinal and/or subretinal fluid (Dry); if "yes" to any of the 2 measurements, there was retinal and/or subretinal fluid (Not Dry); other than the previous 2 cases, retinal and/or subretinal fluid was undetermined.
Group
Value
95% CI
REGN910-3 (3 mg:2 mg)
0.49
REGN910-3 (6 mg:2 mg)
0.51
Aflibercept (IAI) 2 mg
0.44
Proportion of Participants With No Retinal and/or Subretinal Fluid From Baseline Through Week 36Secondary· Baseline through Week 36
Retinal and/or subretinal fluid was assessed using intraretinal fluid (IRF) cystoid edema and subretinal fluid (SRF) in the center subfield on OCT. If answers were "no" to both measurements, there was no retinal and/or subretinal fluid (Dry); if "yes" to any of the 2 measurements, there was retinal and/or subretinal fluid (Not Dry); other than the previous 2 cases, retinal and/or subretinal fluid was undetermined.
Time to No Retinal and/or Subretinal Fluid Through Week 36Secondary· Baseline through Week 36
Kaplan-Meier estimated time to no retinal and/or subretinal fluid through week 36 (days). Retinal and/or subretinal fluid was assessed using intraretinal fluid (IRF) cystoid edema and subretinal fluid (SRF). If answers were "no" to both measurements, there was no retinal and/or subretinal fluid (Dry); if "yes" to any of the 2 measurements, there was retinal and/or subretinal fluid (Not Dry); other than the previous 2 cases, retinal and/or subretinal fluid was undetermined.
Time frame: Timeframe for AE reporting.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
REGN910-3 3 mg:2 mg
Serious: 11/60 (18%)
Deaths: 1/60
REGN910-3 6 mg:2 mg
Serious: 20/122 (16%)
Deaths: 2/122
IAI 2 mg
Serious: 30/183 (16%)
Deaths: 7/183
IAI 2mg to REGN910-3
Serious: 8/58 (14%)
Deaths: 3/58
Serious adverse events (64 terms)
Reaction
System
REGN910-3 3 mg:2 mg
REGN910-3 6 mg:2 mg
IAI 2 mg
IAI 2mg to REGN910-3
Pneumonia
Infections and infestations
—
—
—
—
Acute myocardial infarction
Cardiac disorders
—
—
—
—
Cellulitis
Infections and infestations
—
—
—
—
Sepsis
Infections and infestations
—
—
—
—
Fall
Injury, poisoning and procedural complications
—
—
—
—
Hip fracture
Injury, poisoning and procedural complications
—
—
—
—
Rib fracture
Injury, poisoning and procedural complications
—
—
—
—
Metastases to bone
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The primary objective of the study is to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Regeneron Pharmaceuticals
Last refreshed: 7 May 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02713204.