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


CONCLUSIONS
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.
Chew
Emily Y
EY
Clinical Trials Branch, Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, MD 20892-1204, USA. echew@nei.nih.gov
Kim
Jonghyeon
J
Coleman
Hanna R
HR
Aiello
Lloyd Paul
LP
Fish
Gary
G
Ip
Michael
M
Haller
Julia A
JA
Figueroa
Maria
M
Martin
Daniel
D
Callanan
David
D
Avery
Robert
R
Hammel
Keri
K
Thompson
Darby J S
DJ
Ferris
Frederick L
FL
D000284:Administration, Oral; D002199:Capillary Permeability; D000068579:Celecoxib; D003131:Combined Modality Therapy; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D003930:Diabetic Retinopathy / Q000503:physiopathology / Q000628:therapy*; D005260:Female; D005451:Fluorescein Angiography; D005500:Follow-Up Studies; D006801:Humans; D053844:Lasers, Solid-State / Q000627:therapeutic use*; D008269:Macular Edema / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D011720:Pyrazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D012160:Retina / Q000473:pathology; D013449:Sulfonamides / Q000008:administration & dosage / Q000627:therapeutic use*; D041623:Tomography, Optical Coherence; D014792:Visual Acuity / Q000502:physiology
D052246:Cyclooxygenase 2 Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib