Comparison of Treatments in Diabetic Macular Edema

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Prospective or cohort study to compare the effects of grid macular laser, topical bromfenac 0.09% and placebo (carboxymethyl cellulose 0.5%) medication in diabetic macular edema.

60 eyes with macular edema of two types i.e. cystoid macular edema (CME) and clinically significant macular edema (CSME) were divided into three groups with 20 patients in each group. One group was treated with grid laser photocoagulation, the second group was treated with topical bromfenac 0.09% drops two times a day and the third group was treated with topical carboxy methyl cellulose 0.5% three times a day (placebo treatment).

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

Details

• Lead Sponsor: Babasaheb Ambedkar Memorial Hospital
• Treatments: Bromfenac; Ophthalmic Solutions

Criteria

Inclusion Criteria:

i. Patient with type 1 or type 2 diabetes. ii. The study eye met the following:

1. OCT thickness of the macula upto 400 microns.

2. On clinical examination, definite retinal thickening due to diabetic macular edema within 3000 μm of the center of the macula.

iii. Patient with well controlled blood sugar levels i.e. fasting blood sugar level < 110mg% and post prandial blood sugar level < 126 mg%. Also HbA1c level less than 7%.

iv. Able and willing to provide informed consent. v. Media clarity, pupillary dilation, and study participant cooperation sufficient for adequate OCT and fundus photographs.

vi. Normal optic disc.

Exclusion Criteria:

1. Use of systemic corticosteroids for any other systemic condition or previous anti-Vascular endothelial growth factor (VEGF) therapy.

2. Current use of prescription systemic NSAIDs.

3. Known allergy to bromfenac.

4. History of use of NSAID eye drops within the last 30 days or anticipated need for such drops during the study due to other ocular conditions.

5. Any ocular condition, coexisting with diabetic macular edema, which might affect visual acuity.