Τίτλος:
Infliximab for Diabetic Macular Edema Refractory to Laser
Photocoagulation A randomized, double-blind, placebo-controlled,
crossover, 32-week study
Περίληψη:
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 Ill 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.
Συγγραφείς:
Sfikakis, Petros P.
Grigoropoulos, Vlassis
Emfietzoglou, Ioannis
and Theodossiadis, George
Tentolouris, Nicholas
Delcha, Evi and
Katsiari, Christina
Alexiadou, Kleopatra
Hatziagelaki, Erifili
and Theodossiadis, Panayiotis G.
