A Randomised Trial of Intravitreal Triamcinolone verses Macular Laser Therapy for Persistent Clinically Significant Diabetic Macular Oedema

Abstract

Purpose: : To determine whether repeated intravitreal triamcinolone (IVTA) improved best corrected visual acuity (BCVA) compared to adjunctive conventional laser therapy in diabetic patients with persistent clinically significant macula edema (CSME)

Methods: : Eighty eight patients with persistent CSME after at least one macular laser therapy and visual acuity between 20/40 and 20/400 were randomised to IVTA (4mg) or further macular laser therapy. Both were repeated at 4 and 8 months if CSME persisted. Patients with macular ischemia, defined as a foveal avascular zone diameter greater than 1000um or severe perifoveal capillary dropout were excluded. The primary endpoint was best corrected visual acuity (BCVA) letter score at one year, secondary endpoints were OCTIII macular thickness and volume at 1 year.

Results: : Forty three patients (mean age 62.3yrs) and forty five patients (mean age 64.8) years were enrolled in the IVTA and laser arms respectively. 35 patients in the IVTA and 39 in the laser group were pseudophakic, 8 patients in both groups had proliferative diabetic retinopathy, the remainder had NDPR. At baseline BCVA was 55 (IVTA) vs 53 letters (laser groups) (p=0.59). At one year, BCVA letter score was 53 and 56 letters respectively (p=0.49), mean retinal thickness was 320um (IVTA) vs 333um (laser group) (p=0.78) and macular volume was 8.3 ul (IVTA) vs 8.8ul (laser) (p=0.43). In the IVTA goup one patient developed infective endophthalmitis and 19/43 required topical medication for raised intraocular pressure although none required surgery

Conclusions: : The data does not suggest that repeated intravitreal triamcinolone causes sustained improvemen in visual acuity in patients with persistent clinically significant diabetic macular edema.

Keywords: diabetic retinopathy • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • macula/fovea