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COMPLETED
NCT04411693
PHASE4

Comparative Study of Dexamethasone Implant to Intravitreal Aflibercept in Subjects With Diabetic Macular Edema

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

Summary

This study is an interventional, prospective randomized study comparing the dexamethasone implant to intravitreal aflibercept. Subjects will have an initial single injection of aflibercept and will be randomized if diabetic macular edema persists. Each subject will be evaluated for 6 months following randomization. Thus, the study duration will be 12 months plus the recruitment period. Subjects will be evaluated every month for safety, efficacy as measured by SDOCT and best corrected visual acuity (BCVA) using the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) protocol. In addition, ultra-widefield angiography will be performed at run-in visit, baseline, month 3, and month 6.

Official title: Prospective Randomized Comparative Trial for Combination Dexamethasone Implant With PRN Anti-VEGF Therapy to Anti-VEGF Therapy Alone in Treatment Resistant DME: Informing the Role for Imaging Biomarkers

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

23

Start Date

2020-04-10

Completion Date

2025-05-14

Last Updated

2026-07-29

Healthy Volunteers

Yes

Interventions

DRUG

Dexamethasone implant

A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.

DRUG

Aflibercept

A single dose, 2mg, drug administered by intravitreal injection.

Locations (1)

Retina Consultants of Houston

Houston, Texas, United States