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Evaluation of the Retina in Patients With Non-proliferative Diabetic Retinopathy After Aflibercept Injection in the Eye

NCT04702048 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2021-05-05

No results posted yet for this study

Summary

The purpose of this study is to specifically assess the effect of intravitreal aflibercept injections on the health of cells and the flow of blood through the retinal blood vessels by using advanced technology called adaptive optics.

Conditions

  • Retinopathy, Diabetic

Interventions

DRUG

Aflibercept Injection

Patients randomized to Arm A will receive 2 mg IVT aflibercept injections every 4 weeks (Q4W) to Week 20, followed by 2-mg aflibercept injections Q8W to Week 52.

DRUG

Sham injection

Patients randomized to Arm B will receive sham intravitreal injections every 4 weeks (Q4W) to Week 20, followed by sham intravitreal injections Q8W to Week 52. Sham means eye will be numbed and a syringe with no needle will be touched to the eye.

Sponsors & Collaborators

  • University of Rochester

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2024-02-01
Completion
2024-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT04702048 on ClinicalTrials.gov