Short-term Additive Effect of Topical Ketorolac on the Management of Diabetic Macular Edema With Intravitreal Bevacizumab
Status:
Completed
Trial end date:
2020-06-20
Target enrollment:
Participant gender:
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.