Study: Macugen as first-line treatment improves patients' vision

WAILEA, Hawaii — Using pegaptanib sodium as a first-line therapy in the treatment of age-related macular degeneration produced significantly better visual results than those reported in previous clinical trials, according to a presenter here.

Speaking at Retina 2006, held in conjunction with Hawaiian Eye 2006, Polly Quiram, MD, discussed the results of a retrospective study of patients who received Macugen (pegaptanib, Pfizer/OSI) as a first-line treatment.

The study included the first 90 patients with fresh lesions who had not been previously treated, Dr. Quiram said. Patients with lesions of all sizes and with all levels of visual acuity were included.

Average visual acuity at baseline was 20/80. After treatment with Macugen, visual acuity improved to about a mean 20/50, with some patients achieving 20/20 or 20/25.

“Our results were a surprise even to us,” Dr. Quiram said.

Of these previously untreated patients, 90% had stabilized or improved vision after Macugen treatment. Of that group, 20% experienced at least a three-line gain in VA and 70% had stabilized vision, she said.

Dr. Quiram contrasted these results to those of the VISION (VEGF Inhibition Study in Ocular Neovascularization) trial. In that trial, just 6% of patients demonstrated a three-line or more vision gain, and 30% had stabilized vision, she said.

Dr. Quiram said many of the patients treated as part of the VISION trial had undergone previous procedures and had poor visual function from the outset.

When Dr. Quiram began using Macugen as a first-line therapy, she noted that results were “substantially better” than she had expected based on results from the VISION trial.

“With our increased use of Macugen, we noticed a significant number of above-line gainers,” she said. “Our impression was that Macugen had better results than those recorded in the VISION trial; this was the impetus of our study.”

Follow-up in the retrospective study ranged from 3 to 11 months; the mean number of injections needed to reach a three-line or more gain was 3.5, she said.

Dr. Quiram said the study's limitations include its small size and a selection bias away from predominantly classic lesions.

“The importance to us is that it has validated our current treatment of Macugen, using it as a first-line treatment for occult and minimally classic lesions,” she said. “We hope that other centers similar to ours will retrospectively review their data so we can identify the more responsive subtypes and can better evaluate combination therapy.”