NCT04119921

Short-term Additive Effect of Topical Ketorolac on the Management of Diabetic Macular Edema With Intravitreal Bevacizumab

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 30 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Purpose: To evaluate the short-term effect of adding topical ketorolac to the management of diabetic macular edema (DME) with intravitreal bevacizumab (IVB). Setting: Ophthalmology department of Imam Hossein and Torfe Medical Centers. Ophthalmic Epidemiology Research Center of Shahid Beheshti University of Medical Sciences Methods: In a randomized double-masked placebo-controlled crossover clinical trial, all eyes with DME with best-corrected visual acuity (BCVA) between 20/40 and 20/400 were included. They should have had at least one intravitreal anti-VEGF injection in the past 2 months. They were randomized into two groups. Both groups received two IVB injections with 6-week interval. One group received topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval. The other group received the opposite medications. Best-corrected visual acuity (BCVA) and central macular thickness (CMT) evaluations were repeated at the termination of each treatment period i.e. at 6 and 12 weeks. The main outcome measure was BCVA changes in logMAR and the second outcome was CMT changes. The interim analysis of this study is presented in this report.

Conditions

• DME

Interventions

Type	Name	Description
DRUG	prescription topical ketorolac in group 1	topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.
DRUG	prescription artificial tear in group 2	artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.
DRUG	prescription topical ketorolac in group 2	artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.
DRUG	prescription artificial tear in group1	topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-06-01
• Completion: 2020-06-20
• First posted: 2019-10-09
• Last updated: 2021-02-23

Locations

1 site across 1 country: Iran