Short-term additive effect of topical ketorolac on the management of diabetic macular edema with intravitreal bevacizumab; Interim analysis of a randomized double-masked placebo-controlled crossover clinical trial
Alireza Ramezani1 *
- Hossein Molazem
Abstract: 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: 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.
Results: Results: A total of 24 eyes of 15 patients with DME enrolled in the study. Statistical analysis disclosed that the carryover effect and the period effect were not significant in both BCVA (P=0.245 and P=0.556, respectively) and CMT (P=0.666 and P=0.642, respectively). BCVA change was 0.02±0.13 logMAR in the periods of receiving topical ketorolac and 0.02±0.16 logMAR in the periods of placebo treatment, respectively. Corresponding changes in CMT was 16±80 and 5±78 microns in the treatment and placebo periods, respectively. The treatment effect was not significant regarding both BCVA and CMT changes (P=0.726 and P=0.432, respectively).
Conclusion: Conclusion: This crossover clinical trial demonstrated that in the course of DME treatment with IVB injections, topical ketorolac did not have any additive beneficial effect at least in short term. However, this report represents the result of an interim analysis and more subjects are still needed to confirm this conclusion.
