Preliminary assessment of celecoxib and microdiode pulse laser treatment of diabetic macular edema

Abstract

Purpose: Inflammation may play an important role in the pathogenesis of diabetic macular edema, a major cause of vision loss in persons with diabetes. The purpose of this study was to evaluate combined antiinflammatory therapy and laser approaches for treating patients with diabetic macular edema.

Methods: In this prospective, factorial, randomized, multicenter trial, we compared cyclo-oxygenase-2 inhibitor (celecoxib) with placebo and diode grid laser with standard Early Treatment Diabetic Retinopathy Study focal laser treatment in 86 participants with diabetic macular edema. The primary outcome is change in visual acuity of > or = 15 letters from baseline, and the secondary outcomes include a 50% reduction in the retinal thickening of diabetic macular edema measured by optical coherence tomography and a 50% reduction in leakage severity on fluorescein angiography.

Results: Visual acuity and retinal thickening data from >2 years of follow-up did not show evidence of differences between the medical and laser treatments. However, participants assigned to the celecoxib group were more likely to have a reduction in fluorescein leakage when compared with the placebo group (odds ratio = 3.6; P < 0.01).

Conclusion: This short-term study did not find large visual function benefits of treatment with celecoxib or diode laser compared with those of standard laser treatment. A suggestive effect of celecoxib in reducing fluorescein leakage was observed.

Fig. 1

The enrollment and randomization of the study participants.

Fig. 2

The mean change in visual acuity in participants assigned to celecoxib or placebo.

Fig. 3

Life table estimates of the time to progression in fluorescein leakage in participants assigned to celecoxib or placebo.

Fig. 4

At baseline (A), the clinically significant macular edema of this left study eye of a 31-year-old man with a 16-year history of diabetes had fluorescein leakage that was reduced significantly at 24 months. He did not receive laser photocoagulation during the course of the study (B).