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Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)

NCT02718326 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 402

Last updated 2020-07-30

Study results available
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Summary

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

Conditions

  • Nonproliferative Diabetic Retinopathy

Interventions

DRUG

Intravitreal aflibercept injection [IAI]

DRUG

Sham

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-29
Primary Completion
2018-08-06
Completion
2019-07-16
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Hungary
  • Japan
  • Puerto Rico
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02718326 on ClinicalTrials.gov