Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)
CompletedPhase 3Results postedLast updated 30 July 2020
What this trial tests
Phase 3 trial testing Intravitreal aflibercept injection [IAI] in Nonproliferative Diabetic Retinopathy in 402 participants. Completed in 16 July 2019.
18 and older, any sex, with Nonproliferative Diabetic Retinopathy. 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.
Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8 GroupsPrimary· At Week 24
The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 24 from baseline.
Group
Value
95% CI
Sham Treatment
6.0
Intravitreal Aflibercept Injection (IAI) 2Q16
61.5
Intravitreal Aflibercept Injection (IAI) 2Q8
55.2
IAI 2 mg Groups Combined (2Q16 & 2Q8)
58.4
Percentage of Participants With a ≥ 2-step Change at Week 52 in Diabetic Retinopathy Severity Scale (DRSS) From BaselinePrimary· At Week 52
The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 52 from baseline.
Group
Value
95% CI
Sham Treatment
15.0
Intravitreal Aflibercept Injection (IAI) 2Q16
65.2
Intravitreal Aflibercept Injection (IAI) 2Q8
79.9
Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 52Secondary· At Week 52
Vision-threatening complications are defined as the composite outcome of proliferative diabetic retinopathy (PDR) (inclusive of participants who have vitreous hemorrhage or tractional retinal detachment believed to be due to PDR) and anterior segment neovascularization (ASNV) (participants with neovascularization of the iris \[at least 2 cumulative clock hours\], and/or definitive neovascularization of the iridocorneal angle).
Group
Value
95% CI
Sham Treatment
20.3
Intravitreal Aflibercept Injection (IAI) 2Q16
3.7
Intravitreal Aflibercept Injection (IAI) 2Q8
3.0
Percentage of Participants Who Developed Central Involved-Diabetic Macular Edema (CI-DME) at Week 52Secondary· At Week 52
The percentage of participants who developed CI-DME at week 52 were reported.
Group
Value
95% CI
Sham Treatment
25.6
Intravitreal Aflibercept Injection (IAI) 2Q16
6.7
Intravitreal Aflibercept Injection (IAI) 2Q8
8.2
Time to Development of Any Neovascular Vision Threatening Complication (PDR/ASNV) Through Week 52Secondary· Baseline through week 52 (day 365)
Vision-threatening complication (VTC) is defined as the composite outcome of proliferative diabetic retinopathy (PDR) (inclusive of participants who have vitreous hemorrhage or tractional retinal detachment believed to be due to PDR) and anterior segment neovascularization (ASNV) (participants with neovascularization of the iris \[at least 2 cumulative clock hours\], and/or definitive neovascularization of the iridocorneal angle). Vision Threatening Complications include PDR/ASNV identified by investigators and Diabetic Retinopathy Scale Score (DRSS) \>61.
Group
Value
95% CI
Sham Treatment
NA
371 – NA
Intravitreal Aflibercept Injection (IAI) 2Q16
NA
NA – NA
Intravitreal Aflibercept Injection (IAI) 2Q8
NA
NA – NA
Time to Development of Central Involved-Diabetic Macular Edema (CI-DME) Through Week 52Secondary· Baseline through week 52 (day 365)
Time to develop Central Involved-Diabetic Macular Edema (CI-DME) through week 52 reported.
Group
Value
95% CI
Sham Treatment
NA
333 – NA
Intravitreal Aflibercept Injection (IAI) 2Q16
NA
NA – NA
Intravitreal Aflibercept Injection (IAI) 2Q8
NA
NA – NA
Percentage of Participants Who Received Panretinal Photocoagulation (PRP), Inclusive of Participants Undergoing Vitrectomy With Endolaser, at Week 52Secondary· At Week 52
The percentage of participants who received panretinal photocoagulation (PRP), inclusive of participants undergoing vitrectomy with endolaser, at week 52 were reported.
Group
Value
95% CI
Sham Treatment
6.8
Intravitreal Aflibercept Injection (IAI) 2Q16
0.7
Intravitreal Aflibercept Injection (IAI) 2Q8
0.7
Area Under the Curve (AUC) for Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 52Secondary· At week 52
The area under the curve (AUC) is the area under the best corrected visual acuity (BCVA) versus time curve from baseline to week 52. Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best).
Group
Value
95% CI
Sham Treatment
0.5
± 3.01
Intravitreal Aflibercept Injection (IAI) 2Q16
1.7
± 3.50
Intravitreal Aflibercept Injection (IAI) 2Q8
1.3
± 3.49
Adverse events — posted to ClinicalTrials.gov
Time frame: All Adverse Events (AEs) were collected from signature of the informed consent form up to week 100 regardless of seriousness or relationship to investigational product.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The primary objective of the study is to assess the efficacy of intravitreal (IVT) aflibercept compared to sham treatment in the improvement of moderately severe to severe nonproliferative diabetic retinopathy (NPDR).
The secondary objectives of the study are:
* To characterize the safety of IVT aflibercept in patients with moderately severe to severe NPDR
* To determine if IVT aflibercept will prevent the worsening of diabetic retinopathy and reduce the incidence of DME
* To determine the anatomic effects of IVT aflibercept in patients with moderately severe to severe NPDR
Publications & conference data
8 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
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Sponsor: as reported to ClinicalTrials.gov by Regeneron Pharmaceuticals
Last refreshed: 30 July 2020
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/NCT02718326.