A randomized, double-masked controlled clinical trial of Sandostatin long-acting release depot in patients with postsurgical cystoid macular edema

Retina. 2010 Jan;30(1):160-6. doi: 10.1097/IAE.0b013e3181bced93.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents, Hormonal / administration & dosage*
  • Chronic Disease
  • Delayed-Action Preparations
  • Double-Blind Method
  • Female
  • Fluorescein Angiography
  • Humans
  • Injections, Intramuscular
  • Macular Edema / drug therapy*
  • Macular Edema / etiology
  • Macular Edema / physiopathology
  • Male
  • Middle Aged
  • Octreotide / administration & dosage*
  • Postoperative Complications*
  • Prospective Studies
  • Retina / pathology
  • Treatment Outcome
  • Visual Acuity / physiology

Substances

  • Antineoplastic Agents, Hormonal
  • Delayed-Action Preparations
  • Octreotide