A randomized, double-masked controlled clinical trial of Sandostatin long-acting release depot in patients with postsurgical cystoid macular edema.
Publication/Presentation Date
1-1-2010
Abstract
PURPOSE: The purpose of this study was to evaluate the safety and efficacy of octreotide, a somatostatin analog, for treatment of postsurgical cystoid macular edema.
METHODS: Twenty-one patients with chronic, refractory postsurgical cystoid macular edema and Early Treatment Diabetic Retinopathy Study best-corrected visual acuity of 20/25 to 20/400 were randomized 2:1 to 30 mg monthly intramuscular octreotide or placebo. Outcome measures were visual acuity (primary) and macular thickness and fluorescein angiographic leakage (secondary).
RESULTS: Fourteen eyes received octreotide and seven eyes received placebo. Mean duration of cystoid macular edema was 2.65 and 1.99 years for Sandostatin long-acting release and placebo groups, respectively. Visual acuity at 6 months improved > or =2 lines in 7 of 14 eyes (50%) in the treatment group and 0 of 7 eyes in the placebo group (P = 0.046). Improvement in retinal thickening and angiographic leakage occurred in 3 of 13 eyes (23.1%) and 3 of 14 eyes (21.4%) of the treatment group, respectively, and in 1 of 7 eyes (14.3%) (P = 1.0 compared with the treatment group) and 0 of 7 eyes in the placebo group (P = 0.52 compared with the treatment group). The three eyes that improved in all parameters were treated with octreotide.
CONCLUSION: Although there were no statistically significant differences between both groups in retinal thickening or angiographic leakage, octreotide-treated patients were more likely to experience a > or =2-line improvement in visual acuity. However, this observation cannot be generalized because of the small sample size.
Volume
30
Issue
1
First Page
160
Last Page
166
ISSN
1539-2864
Published In/Presented At
Shah, S. M., Nguyen, Q. D., Mir, H. S., Polito, A., Hafiz, G., Tatlipinar, S., Do, D. V., Vitale, S., & Haller, J. A. (2010). A randomized, double-masked controlled clinical trial of Sandostatin long-acting release depot in patients with postsurgical cystoid macular edema. Retina (Philadelphia, Pa.), 30(1), 160–166. https://doi.org/10.1097/IAE.0b013e3181bced93
Disciplines
Business Administration, Management, and Operations | Health and Medical Administration | Management Sciences and Quantitative Methods
PubMedID
20061906
Department(s)
Administration and Leadership
Document Type
Article