Overview

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