Intravitreal TNF Inhibitors in the Treatment of Refractory Diabetic Macular Edema: A Pilot Study From the Pan American Collaborative Retina Study Group

Abstract

Purpose: : 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).

Methods: : 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.

Results: : 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.

Conclusions: : 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.

Keywords: diabetic retinopathy • edema • injection