NCT04411693

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-04-10
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2020-06-02
• Last updated: 2024-06-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study