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: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shahid Beheshti University of Medical Sciences
• Treatments: Bevacizumab; Ketorolac; Ketorolac Tromethamine; Lubricant Eye Drops

Criteria

Inclusion Criteria:

• BCVA≤20/40 and BCVA 20/400 and better

• History of at least 1 intra-viteral bevacizumab (IVB) in the last 2 months

• Requires 2 IVB in the next 12 weeks

• Macular thickness >300 μm

• NO Other eye diseases

• Media clarity , pupillary dilation, and subject cooperation sufficient for adequate fundus photographs

Exclusion Criteria:

• hgb A1c> 8

• high risk PDR

• Macular edema due to a cause other than diabetic retinopathy

• Any other ocular condition that visual acuity would not improve from resolution of edema (eg.foveal atrophy)

• Prior treatment with intravitreal or peribulbar corticosteroid injection during last 3months

• History of macular photocoagulation during the last 6 months

• intraocular surgery(except cataract surgery)

• Cataract extractionin less than 6 months ago

• Uveitis ,NVG ,exudative AMD, HR PDR.

• Uncontrolled glaucoma

• Vitreomacular traction or epiretinal membrane