Infliximab for Diabetic Macular Edema Refractory to Laser Photocoagulation: a Randomized, Double-Blind, Placebo-Controlled, Crossover, 32 Weeks Study

  1. Panayiotis G. Theodossiadis, MD3
  1. 1First Department of Propaedeutic and Internal Medicine, Laiko General Hospital
  2. 2Ophthalmology Department, Henry Dynan Hospital
  3. 3Ophthalmology Department, Attikon Hospital, Athens University Medical School, Athens Greece


Objective. Since many patients with diabetic macular edema do not respond to focal/grid laser photocoagulation, the only currently approved treatment, alternatives are needed. Based on encouraging preliminary findings, we aimed to assess efficacy and safety of the anti-TNF monoclonal antibody infliximab in this condition.

Research Design and Methods. Single-center, double-blind, randomised, placebo-controlled, crossover study (www.clinicalTrials.govNCT00505947). Eleven patients with sight-threatening diabetic macular edema persisting after 2 sessions of laser photocoagulation received infliximab (5mg/kg) intravenously at weeks 0, 2, 6, and 14, followed by placebo at weeks 16, 18, 22, and 30, or vice versa. Blinding was maintained to week 32, when the final assessments were performed. Best corrected visual acuity evaluated by mixed models approach for imbalanced crossover design using the percentage difference as outcome variable was the primary study end-point. Data were analysed on intention to treat basis.

Results. EDTRS scores dropped from 31.6±5.1 (mean±SD letters read) at baseline to 28.8±11.6 at week 16 in 6 placebo-treated eyes and improved to 35.4±.11.2 after infliximab. In contrast, visual acuity improved from 23.5±10.3 at baseline to 30.4±13.4 letters at week 16 in 8 infliximab-treated eyes and was sustained at completion of placebo treatment (31.4±12.1). The excess visual acuity in infliximab-treated eyes was greater by 24.3% compared with placebo-treated eyes (95%CI:[4.8%-43.7%], P=0.017). Infliximab treatment was well tolerated.

Conclusions. The positive results of this small phase III study suggest that larger and longer term trials should assess the efficacy of systemic or intravitreal anti-TNF agent administration for primary treatment of diabetic macular edema .


    • Received December 29, 2009.
    • Accepted April 1, 2010.