Pegaptanib Appears Safe, Effective as Maintenance Therapy in Age-Related Macular Degeneration

 

May 01, 2008

May 1, 2008 (Fort Lauderdale) — Pegaptanib can maintain or improve visual acuity in patients with neovascular age-related macular degeneration (AMD), according to a study presented here at the Association for Research in Vision and Ophthalmology 2008 Annual Meeting.

AMD is a chronic, progressive disease that may require ongoing management. This analysis evaluated the safety and efficacy of pegaptanib (Macugen, (OSI) Eyetech and Pfizer) as a maintenance treatment, particularly in light of the fact that the drug may be a good maintenance treatment for those at risk for myocardial infarction and stroke.

Using data from the Evaluation of Efficacy and Safety in Maintaining Visual Acuity With Sequential Treatment of Neovascular AMD study, which explored the safety and efficacy of pegaptanib as a maintenance therapy for patients who showed improvement after induction for AMD, this new research looked at 211 patients, aged 50 years or older, who had subfoveal AMD and visual acuity ranging from 20/20 to 20/400. Pegaptanib was administered every 6 weeks for 48 weeks, with booster treatments using other agents allowed at the investigator's discretion for deteriorating AMD.

Induction therapies were bevacizumab (39%), ranibizumab (32%), multiple agents (22%), and others (7%). During induction, mean visual acuity improved from 50.3 to 65.8 letters and generally stayed the same during the maintenance phase (36-week mean, 62.5 letters). Of the 211 patients, 41% gained 3 lines of vision or more, 71% gained at least some vision (≥0), and 88% lost fewer than 3 lines.

"The use of boosters was a major issue we looked at in the study," lead author Thomas R. Friberg, professor of ophthalmology and bioengineering at the University of Pittsburgh, Pennsylvania, told attendees during his presentation. "There were not many boosters given, but there were some," he added.

Booster treatment was administered in 59% of subjects; 60% received 1 booster, and the mean time to first booster was 125 days after the start of maintenance therapy.

At 36 weeks, the rate of adverse events was similar to those in the VEGF Inhibition Study in Ocular Neovascularization (VISION), and no new ocular or systemic safety signals were seen.

Subjects maintained relative visual and anatomical stability during the maintenance period. The researchers also noted that pegaptanib maintenance provides an alternative to nonselective anti–vascular endothelial growth factor (VEGF) agents, which may be important for these older patients who are more likely to be at risk for cardiovascular events, including myocardial infarction and stroke.

"The visual results of this strategy were really rather good, with a high percentage of patients maintaining 2- and 3-line gains of acuity over the year, and 41% had 3 lines of acuity gain from their preinduction vision," Dr. Friberg told Medscape Ophthalmology. "As pegaptanib is an alternative to nonselective anti-VEGF agents, this paradigm may be particularly valuable in patients at higher risk of thromboembolism or cardiovascular events," he added.

"To try and figure out maintenance using a nonselective anti-VEGF agent is a very interesting concept," said Joan W. Miller, MD, chief and chair of ophthalmology at Harvard Medical School Massachusetts Eye and Ear Infirmary in Boston, one of the session moderators. "It would be interesting to see the subgroup analysis comparing the different inductions to try and find out if the agent used affected the final outcome," added Dr. Miller, who was not involved in the study.

The study was supported by Pfizer Inc. Dr. Friberg disclosed a commercial relationship with Pfizer Inc.

Association for Research in Vision and Ophthalmology 2008 Annual Meeting: Abstract 2886. Presented April 29, 2008.

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