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Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease

NCT04429503 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2025-08-08

Study results available
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Summary

The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks.

The secondary objectives of the study are as follows:

* To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response
* To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept

Conditions

Interventions

DRUG

aflibercept

Intravitreally (IVT) administered as a liquid formulation in a vial

DRUG

High-dose aflibercept

Intravitreally (IVT) administered as a liquid formulation in a vial

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
2020-06-29
Primary Completion
2022-05-30
Completion
2024-06-18
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT04429503 on ClinicalTrials.gov