Infliximab for Diabetic Macular Edema Refractory to Laser Photocoagulation
| Autor: | Evi Delicha, Petros P. Sfikakis, Panayiotis G. Theodossiadis, Kleopatra Alexiadou, Ioannis Emfietzoglou, Vlassis G. Grigoropoulos, George Theodossiadis, Christina G. Katsiari, Erifili Hatziagelaki, Nicholas Tentolouris |
|---|---|
| Rok vydání: | 2010 |
| Předmět: |
Adult
Male medicine.medical_specialty Visual acuity Randomization genetic structures Emerging Treatments and Technologies Endocrinology Diabetes and Metabolism medicine.medical_treatment Anti-Inflammatory Agents Visual Acuity Placebo Macular Edema Placebos Double-Blind Method Ophthalmology Internal Medicine medicine Humans Macular edema Original Research Aged Advanced and Specialized Nursing Cross-Over Studies Diabetic Retinopathy Laser Coagulation Tumor Necrosis Factor-alpha business.industry Antibodies Monoclonal Diabetic retinopathy Middle Aged medicine.disease Crossover study Infliximab Surgery Treatment Outcome Female medicine.symptom business Laser coagulation medicine.drug |
| Zdroj: | Diabetes Care |
| ISSN: | 1935-5548 0149-5992 |
| DOI: | 10.2337/dc09-2372 |
| Popis: | OBJECTIVE Because many patients with diabetic macular edema (DME) 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–tumor necrosis factor (TNF) monoclonal antibody infliximab in this condition. RESEARCH DESIGN AND METHODS This was a single-center, double-blind, randomized, placebo-controlled, crossover study. Eleven patients with sight-threatening DME persisting after two sessions of laser photocoagulation received infliximab (5 mg/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 a mixed-models approach for imbalanced crossover design using the percentage difference as the outcome variable was the primary study end point. Data were analyzed on an intention-to-treat basis. RESULTS Early Treatment of Diabetic Retinopathy Study (ETDRS) scores dropped from 31.6 ± 5.1 (mean ± SD) letters read at baseline to 28.8 ± 11.6 letters read at week 16 in six placebo-treated eyes and improved to 35.4 ± 11.2 letters read after infliximab. In contrast, visual acuity improved from 23.5 ± 10.3 at baseline to 30.4 ± 13.4 letters read at week 16 in eight infliximab-treated eyes and was sustained at completion of placebo treatment (31.4 ± 12.1 letters read). The excess visual acuity in infliximab-treated eyes was greater by 24.3% compared with that in 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 be conducted to assess the efficacy of systemic or intravitreal anti-TNF agent administration for primary treatment of DME. |
| Databáze: | OpenAIRE |
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