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

Syed Mahmood Ali Shah, Quan Dong Nguyen, Hafsa Syyida Mir, Antonio Polito, Gulnar Hafiz, Sinan Tatlipinar, Diana V. Do, Susan Vitale, Julia A. Haller

Research output: Contribution to journalArticle

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 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.

Original languageEnglish (US)
Pages (from-to)160-166
Number of pages7
JournalRetina
Volume30
Issue number1
DOIs
StatePublished - Jan 2010

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Octreotide
Macular Edema
Controlled Clinical Trials
Placebos
Visual Acuity
Therapeutics
Diabetic Retinopathy
Somatostatin
Fluorescein
Sample Size
Outcome Assessment (Health Care)
Safety

ASJC Scopus subject areas

  • Ophthalmology

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A randomized, double-masked controlled clinical trial of sandostatin long-acting release depot in patients with postsurgical cystoid macular edema. / Shah, Syed Mahmood Ali; Nguyen, Quan Dong; Mir, Hafsa Syyida; Polito, Antonio; Hafiz, Gulnar; Tatlipinar, Sinan; Do, Diana V.; Vitale, Susan; Haller, Julia A.

In: Retina, Vol. 30, No. 1, 01.2010, p. 160-166.

Research output: Contribution to journalArticle

Shah, Syed Mahmood Ali ; Nguyen, Quan Dong ; Mir, Hafsa Syyida ; Polito, Antonio ; Hafiz, Gulnar ; Tatlipinar, Sinan ; Do, Diana V. ; Vitale, Susan ; Haller, Julia A. / A randomized, double-masked controlled clinical trial of sandostatin long-acting release depot in patients with postsurgical cystoid macular edema. In: Retina. 2010 ; Vol. 30, No. 1. pp. 160-166.
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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 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.",
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AU - Polito, Antonio

AU - Hafiz, Gulnar

AU - Tatlipinar, Sinan

AU - Do, Diana V.

AU - Vitale, Susan

AU - Haller, Julia A.

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N2 - 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.

AB - 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.

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