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Study: Pegaptanib shows continued efficacy at 2 years

Study shows patients who continued pegaptanib treatments for a second year were more likely to gain or maintain visual acuity.

ByAndy Moskowitz

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A recent study found that pegaptanib continued to show beneficial effects on vision at 2-year follow-up in patients with exudative age-related macular degeneration. According to the study, published in Ophthalmology, patients taking the drug for a second year were less likely to lose vision than those not taking the drug.

Investigators in the VISION (VEGF inhibition study in ocular neovascularization) trial analyzed data from two concurrent, prospective, randomized, multicenter, double-masked, controlled studies comparing 0.3 mg, 1 mg and 3 mg intravitreous doses of Macugen (pegaptanib sodium, OSI/Pfizer) to sham treatments and usual care. After a 54-week initial efficacy trial, the researchers sought to determine whether a second year of Macugen treatment provided a benefit beyond the first year.

At the start of the initial trial, researchers had randomly assigned patients to receive treatment either with one of the three pegaptanib dosages or sham injections every 6 weeks. At 54 weeks’ follow-up, 1,053 of 1,190 patients (88%) who had received at least one dose were re-randomized to either continue or discontinue pegaptanib treatment. Sham-treated patients were re-randomized to continue sham treatments, discontinue treatments or begin treatment with one of the three pegaptanib dosages every 6 weeks.

Stable visual acuity

At 102 weeks’ follow-up, researchers found that mean visual acuity remained stable in patients who continued treatment with 0.3 mg pegaptanib. Mean VA decreased for patients who discontinued treatment and for those reassigned to receive usual care. Patients who continuously received usual care from baseline had the poorest visual outcomes, the study authors noted.

Researchers found that 10% of patients who continued treatment gained three or more letters of VA and only 7% lost 15 or more letters from baseline. Additionally, only 1% of patients lost vision to the point of legal blindness while continuing pegaptanib treatment.

In contrast, 14% of patients in the discontinuation or usual care groups lost 15 or more letters of VA, and 14% of patients who discontinued treatment and 12% of usual care patients lost vision to the point of legal blindness, according to the study.

Fundus imaging revealed that the expansion of lesion and choroidal neovascularization areas was more rapid during the first year than the second year for all treatment groups. Pegaptanib-treated patients exhibited smaller lesions than those receiving usual care, and patients assigned to discontinue pegaptanib showed a greater mean increase in lesion area than patients who continued treatment, according to the study.

“These data are consistent with the continuing action of VEGF throughout the period of active lesion evolution, as would be anticipated from its importance in promoting choroidal neovascularization and from its unique role as an extremely potent vascular permeability factor in mediating the leakage that is one of the hallmarks of exudative AMD,” the study authors said.

Researchers further found that patients discontinued from pegaptanib were more likely to resume therapy than patients who discontinued from sham. Of 28 pegaptanib-rescued patients, 15 avoided a 15-letter loss from baseline at week 102, compared to two of eight sham-rescued patients, according to the study.

Three percent of patients experienced serious complications, including endophthalmitis, retinal hemorrhage, vitreous hemorrhage and retinal detachment. More common adverse events were anterior chamber inflammation, eye pain, increased IOP, punctate keratitis, vitreous floaters and vitreous opacities, according to a Pfizer press release.

The safety and efficacy of Macugen beyond 2 years have not been demonstrated, company officials said in the release.

For more information:

• Usha Chakravarthy, MD, the corresponding author of this study, can be reached at Centre for Vision Sciences, The Queens University of Belfast and The Royal Victoria Hospital, Belfast BT12 6BA, Northern Ireland, United Kingdom; e-mail: u.chakravarthy@qub.ac.uk.

Reference:

• VISION Clinical Trial Group. Year 2 efficacy results of two randomized controlled clinical trials of pegaptanib for neovascular age-related macular degeneration. Ophthalmology. 2006;113(9):15081521.

• Andy Moskowitz is an OSN Staff Writer who covers all aspect of ophthalmology. He also writes daily updates for OSNSuperSite.com.