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Does Niprisanฎ Retard the Evolution of Sickle Cell Retinopathy?
Abstract
Objective: To investigate the efficacy of Niprisan®, an antisickling agent, in the management of sickle cell retinopathy.
Methods: The study was designed as a phase IIb double-blind, placebo-controlled crossover trial. Eighty-eight patients aged between 5 and 36 years (mean 15.3 years) were randomized into 2 treatment groups. One group received Niprisan® at a dose of 12mg/kg per os per day and the other group a placebo in a similarly encapsulated form, for an initial period of six months. After a crossover without interval washout, the treatment was continued for a further six months. Ocular signs, including jaundice and corkscrew/comma sign in the anterior segment, and signs of non-proliferative, pre-proliferative and proliferative retinopathy in the posterior segment, were assessed with a view to identifying deteriorations within these parameters.
Results: A within-person analysis provided no evidence that Niprisan® reduced the risk of anterior segment deterioration (odds ratio = 0.91; 95% c.i. 0.35, 2.36; p=1.00). Thirteen individuals contributed to the posterior segment analysis, 3 of whom experienced deterioration whilst receiving Niprisan® (odds ratio = 0.30, 95% c.i. 0.05-1.17; p=0.09; Mcnemar chi2 = 3.17, p=0.05).
Conclusion: This study provides evidence that Niprisan® may reduce substantially the risk of posterior segment deterioration.
[Nig. J. Ophthalmology Vol.11(1) 2003: 34-41]
Methods: The study was designed as a phase IIb double-blind, placebo-controlled crossover trial. Eighty-eight patients aged between 5 and 36 years (mean 15.3 years) were randomized into 2 treatment groups. One group received Niprisan® at a dose of 12mg/kg per os per day and the other group a placebo in a similarly encapsulated form, for an initial period of six months. After a crossover without interval washout, the treatment was continued for a further six months. Ocular signs, including jaundice and corkscrew/comma sign in the anterior segment, and signs of non-proliferative, pre-proliferative and proliferative retinopathy in the posterior segment, were assessed with a view to identifying deteriorations within these parameters.
Results: A within-person analysis provided no evidence that Niprisan® reduced the risk of anterior segment deterioration (odds ratio = 0.91; 95% c.i. 0.35, 2.36; p=1.00). Thirteen individuals contributed to the posterior segment analysis, 3 of whom experienced deterioration whilst receiving Niprisan® (odds ratio = 0.30, 95% c.i. 0.05-1.17; p=0.09; Mcnemar chi2 = 3.17, p=0.05).
Conclusion: This study provides evidence that Niprisan® may reduce substantially the risk of posterior segment deterioration.
[Nig. J. Ophthalmology Vol.11(1) 2003: 34-41]
