Comparison of Treatments in Diabetic Macular Edema

PHASE4CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

October 31, 2015

Study Completion Date

October 31, 2015

Conditions
Diabetic Macular Edema
Interventions
PROCEDURE

laser photocoagulation

"Laser Parameters of grid photocoagulation Diffuse diabetic macular edema is treated by a grid pattern of laser. The grid is applied to areas of retinal thickening with diffuse leakage or capillary non-perfusion.~Spot size: 50-100 micron is utilized. The burn intensity for grid laser: barely visible (light grey). Power of laser burn is between 80-100 mw depending on the condition of the laser, the opacities in the media and background pigmentation.~Laser burns should be placed at least one burn width apart, wider if thickening is less severe. If necessary, the grid can extend up to 2 disc diameters superiorly, inferiorly, and temporally from the centre of the macula. One should avoid treating within 500 microns of the disc margin or the centre of the macula.~Duration of about 0.05-0.1 sec is used Number of spots- 100-500"

DRUG

eye drop bromfenac 0.09%

twice daily e/d bromfenac 0.09% for 6 weeks

DRUG

Placebo

Observation group. No intervention done. Only eye drop carboxymethyl cellulose 0.5% to be instilled thrice a day for 6 weeks.

All Listed Sponsors
lead

Babasaheb Ambedkar Memorial Hospital

OTHER_GOV

NCT05715385 - Comparison of Treatments in Diabetic Macular Edema | Biotech Hunter | Biotech Hunter