Anti-VEGF Therapy Versus Dexamethasone Implant for DME

• Status: Not yet recruiting
• Trial end date: 2023-06-24
• Target enrollment: 0
• Participant gender: All

Summary

We look at a randomized comparative study of 2 FDA approved anti-VEGF agents(aflibercept and ranibizumab) and see how they compare against the dexamethasone implant for phakic as well as pseudophakic eyes with treatment naive diabetic macular edema in terms of efficacy and safety over two years.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sudhalkar Eye Hospital
• Treatments: Aflibercept; BB 1101; Bevacizumab; Dexamethasone; Dexamethasone acetate; Ranibizumab

Criteria

Inclusion Criteria:

• Well controlled diabetes(HbA1c<7%) and co-morbidities. Central Subfield Thickness of 300 microns or greater BCVA < or equal to 6/12.

Exclusion Criteria:

• Contraindications to the aforementioned drugs Confounding Ocular co-morbidities that can affect visual assessment(except Cataract Grade II or less as per the LOCS III classification) Macular ischemia or proliferative Disease Refusal for enrolment