Comparison of nepafenac 0.1% and 0.3% eye drops in management of DME
Phase 3
- Conditions
- Health Condition 1: H30-H36- Disorders of choroid and retinaHealth Condition 2: H358- Other specified retinal disorders
- Registration Number
- CTRI/2021/11/038069
- Lead Sponsor
- JIPMER PONDICHERRY
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Patient age > 18 years
2.DME- macular thickness > 250 microns
3.BCVA â?? 6/12 or better, 20/40 letters of ETDRS chart.
Exclusion Criteria
1.Any ocular surgical procedure in past 3 months
2.Any laser/ intra-vitreal injection procedures in past 3 months.
3.Any patient who had undergone cataract surgery in the study eye in past 1 year.
4.Vision 6/18 or poor or 20/60 on ETDRS chart.
5.Uncontrolled sugar
6. Any previous history of allergy to nepafenac.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Reduction of Central sub-field (CSF) macu-lar thickness. <br/ ><br> <br/ ><br>2.No. of eyes with at least 5 letters decrease or increase from baseline in ETDRS chart. <br/ ><br>Timepoint: 1st, 4th, 6th months
- Secondary Outcome Measures
Name Time Method 1.Change in OCT central sub-foveal choroidal thickness from baseline.Timepoint: 1st, 4th, 6th months