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

Diabetic Macular Edema Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04411693
Study type Interventional
Source The Cleveland Clinic
Contact
Status Completed
Phase Phase 4
Start date April 10, 2020
Completion date January 31, 2024
View Details
See also
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