Comparison of nepafenac 0.1% and 0.3% eye drops in management of DME

Comparison of 0.1% Nepafenac and 0.3% Nepafenac eye drops in reduction of macular thickness and improvement of visaul acuity in patient with diabetic macular edema - a randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/11/038069

Enrollment

Registered

2021-11-16

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H30-H36- Disorders of choroid and retina Health Condition 2: H358- Other specified retinal disorders

Interventions

Intervention1: NEPAFENAC 0.3 % EYE DROPS: Nepafenac (Alcon Research, Ltd., Fort Worth, TX), is a topical NSAID which rapidly permeates through the cornea and gains intra-ocular entry. It is then con

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1. Reduction of Central sub-field (CSF) macu-lar thickness. 2. No. of eyes with at least 5 letters decrease or increase from baseline in ETDRS chart. Timepoint: 1st, 4th, 6th months	—

Secondary

Measure	Time frame
1. Change in OCT central sub-foveal choroidal thickness from baseline.Timepoint: 1st, 4th, 6th months	—

Countries

India

Contacts

Public ContactDr Amit kumar Deb

JAWAHARLAL INSTITUTE OF POSTGRADUATE AND MEDICAL EDUCATION AND RESEARCH

amitjipmer@yahoo.co.in9843126534

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026