Study of intravitreal Aflibercept in patients with diabetic eye disease

A Phase 3, Double-Masked, Randomized Study of the Efficacy and Safety of Intravitreal Aflibercept Injection in Patients with Moderately Severe to Severe Nonproliferative Diabetic Retinopathy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002639-14-DE

Enrollment

360

Registered

2016-11-28

Start date

2017-02-24

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NonProliferative Diabetic Retinopathy MedDRA version: 20.1 Level: LLT Classification code 10054109 Term: Non-proliferative diabetic retinopathy System Organ Class: 100000004853

Interventions

Trade Name: Eylea Product Name: Eylea Pharmaceutical Form: Solution for injection INN or Proposed INN: AFLIBERCEPT CAS Number: 862111-32

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Men or women =18 years of age with type 1 or 2 diabetes mellitus who have moderately severe to severe NPDR (DRSS levels 47 or 53), confirmed by the central reading center, in whom PRP can be safely deferred for at least 6 months per the investigator 2. BCVA ETDRS letter score in the study eye of =69 letters (approximate Snellen equivalent of 20/40 or better) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 304 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 56

Exclusion criteria

Exclusion criteria: 1.Presence of DME threatening the center of the macula in the study eye 2.Evidence of retinal neovascularization on clinical examination or Fluorescein Angiography (FA) 3.Any prior focal or grid laser photocoagulation or any prior PRP in the study eye 4.Any prior systemic anti-VEGF treatment or IVT anti-VEGF treatment in the study eye 5.Any prior intraocular steroid injection in the study eye 6.Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye

Design outcomes

Primary

Measure	Time frame
Main Objective: 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).; Secondary Objective: 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 diabetic macular edema (DME) To determine the anatomic effects of IVT aflibercept in patients with moderately severe to severe NPDR. ; Primary end point(s): Proportion of patients who have improved by =2 steps from baseline on the Diabetic Retinopathy Severity Scale (DRSS) score at week 24 Proportion of patients who have improved by =2 steps from baseline on the DRSS score at week 52 ; Timepoint(s) of evaluation of this end point: 24 weeks 52 weeks	—

Measure

Time frame

Main Objective: 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).; Secondary Objective: 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 diabetic macular edema (DME) To determine the anatomic effects of IVT aflibercept in patients with moderately severe to severe NPDR. ; Primary end point(s): Proportion of patients who have improved by =2 steps from baseline on the Diabetic Retinopathy Severity Scale (DRSS) score at week 24 Proportion of patients who have improved by =2 steps from baseline on the DRSS score at week 52 ; Timepoint(s) of evaluation of this end point: 24 weeks 52 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Proportion of patients developing a vision-threatening complication due to diabetic retinopathy Proportion of patients who develop CI-DME Time to development of a vision-threatening complication Time to development of CI-DME Proportion of patients who receive PRP, inclusive of patients undergoing vitrectomy with endolaser Area under the curve (AUC) for change in BCVA from baseline ; Timepoint(s) of evaluation of this end point: Week 52 Week 100 (exploratory manner)	—

Measure

Time frame

Secondary end point(s): Proportion of patients developing a vision-threatening complication due to diabetic retinopathy Proportion of patients who develop CI-DME Time to development of a vision-threatening complication Time to development of CI-DME Proportion of patients who receive PRP, inclusive of patients undergoing vitrectomy with endolaser Area under the curve (AUC) for change in BCVA from baseline ; Timepoint(s) of evaluation of this end point: Week 52 Week 100 (exploratory manner)

—

Countries

Germany, Hungary, Japan, United Kingdom, United States

Contacts

Public ContactClinical Trial Management

Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026