[Pegaptanib sodium one-year treatment study for neovascular age-related macular degeneration]

Abstract

Purpose: To evaluate the safety and efficacy of intravitreal administration of pegaptanib sodium in Japanese patients with age-related macular degeneration associated with subfoveal choroidal neovascularization.

Methods: Ninety-five male and female patients (mean age 72.5 years.) were assigned randomly in a double-masked manner to receive 0.3 or 1 mg of pegaptanib sodium every 6 weeks over a 48-week period. Efficacy was assessed by visual acuity change from baseline as the proportion of patients who lost fewer than 15 letters at week 54 using the Early Treatment Diabetic Retinopathy Study chart.

Results: The group that received 0.3 mg pegaptanib experienced a mean loss of 3.8 letters; 78.7% (37/47) of patients lost fewer than 15 letters. The 1 mg group had a change of -4.3 letters and the proportion that lost 15 letters was 72.9% (35/48). The proportion of patients whose visual acuity was unchanged or improved was 46.8% (22/47) and 43.8% (21/48) in the 0.3 and 1 mg groups, respectively. The majority of adverse events with possible, probable, or unknown relationship to pegaptanib were related to the intravitreal injection, such as mild conjunctival hemorrhage (0.3 mg: 76.6%, 1 mg: 77.1%) and superficial punctuate keratitis by sterilization (0.3 mg: 29.8%, 1 mg: 39.6%) at the injection site. Compliance with the study treatment of 9 intravitre al injections was as high as 87.2% and 85.4% for patients receiving 0.3 and 1 mg, respectively.

Conclusion: Intravitreal injection of sodium pegaptanib every 6 weeks produced clinically significant stabilization of visual acuity for one year in more than 70% of patients with age-related macular degeneration, with good treatment compliance.