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L. Wu, E. Hernandez-Bogantes, J. A. Roca, J. F. Arevalo, K. Barraza, A. F. Lasave, Pan American Collaborative Retina Study Group; Intravitreal TNF Inhibitors in the Treatment of Refractory Diabetic Macular Edema: A Pilot Study From the Pan American Collaborative Retina Study Group. Invest. Ophthalmol. Vis. Sci. 2010;51(13):4247.
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To report the short term visual and anatomic outcomes following intravitreal injections of 2 different tissue necrosis factor (TNF) inhibitors in eyes with refractory diabetic macular edema (DME).
An interventional, retrospective, multicenter study of 39 eyes with refractory DME that were injected with adalimumab (n=5 for 2 mg) or infliximab (n=14 for 1 mg; n=20 for 2 mg). The main outcome measures were the best corrected visual acuity (BCVA) and the central macular thickness (CMT) at 3 months of follow-up.
There were 39 eyes included in the study. 51.2% of patients were male. The mean age was 63.7 yrs. The mean HbA1C at baseline was 7.9%. The average duration of diabetes mellitus was 15.7 yrs. The baseline logMAR visual acuity was 1.16 ± 0.68. At 1 month, the logMAR visual acuity was 1.22 ± 0.77 (p=0.4332) and at 3 months worsened to 1.27 ± 0.74 (p=0.0052). The baseline CMT was 416 ± 122 µm. At 1 month, the CMT was 401 ± 168 µm (p=0.6151), at 3 months the CMT was 380 ± 175 µm (p=0.0076). There were no systemic side effects. None of the eyes injected with 1 mg of infliximab had ocular adverse events. 8 eyes injected with 2 mg of infliximab developed a severe uveitis. Three of these eyes (37.5%) required pars plana vitrectomy. The uveitis in the remaining 5 eyes resolved with topical steroid therapy.
Both intravitreal adalimumab and infliximab do not appear to benefit eyes with refractory DME. The BCVA at 3 months appear to have worsened with a paradoxical decrease in CMT. Intravitreal injections of infliximab may elicit a severe intraocular inflammatory reaction that appears to be dose related.
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