A RANDOMIZED, DOUBLE-MASKED CONTROLLED CLINICAL TRIAL OF SANDOSTATIN LONG-ACTING RELEASE DEPOT IN PATIENTS WITH POSTSURGICAL CYSTOID MACULAR EDEMA

作者：Shah Syed Mahmood Ali; Nguyen Quan Dong; Syyida Hafsa; Polito Antonio; Hafiz Gulnar; Tatlipinar Sinan; Do Diana V; Vitale Susan; Haller Julia A^*

来源：Retina-The Journal of Retinal and Vitreous Diseases, 2010, 30(1): 160-166.

DOI：10.1097/IAE.0b013e3181bced93

• macular edema
• cystoid macular edema
• growth hormone
• IGF-1
• insulin-like growth factor
• octreotide
• optical coherence tomography
• postsurgical cystoid macular edema
• Sandostatin
• Irvine-Gass syndrome

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 >= 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 >= 2-line improvement in visual acuity. However, this observation cannot be generalized because of the small sample size. RETINA 30:160-166,2010

• 出版日期2010-1