Anecortave acetate comparable to PDT in comparison trial

Anecortave acetate was comparable to photodynamic therapy for maintaining vision in patients with predominantly classic choroidal neovascularization, a multicenter study found.

According to the study’s authors, the benefits of anecortave acetate for the treatment of CNV in patients with age-related macular degeneration outweighed the risks associated with the drug and its administration.

Jason S. Slakter, MD, and colleagues randomly assigned 530 patients with predominantly classic subfoveal CNV secondary to AMD to either juxtascleral deposition of anecortave acetate 15 mg or to verteporfin PDT.

Each group received its respective treatment for 12 months, with PDT administered every 3 months and anecortave acetate every 6 months. There were no significant demographic differences between the two groups. The average age of the patients was 76.6 years, and 98% were white.

The study examined the safety of anecortave acetate in comparison to PDT. The researchers said the most frequent adverse event in both groups was a loss of visual acuity of more than four lines.

“The difference in incidence of decreased visual acuity between the two groups is not clinically relevant and, along with the review of the characteristics of the adverse events, does not represent a safety concern for anecortave acetate 15 mg utilized as primary therapy,” the researchers said.

One patient discontinued participation in the study due to an effect possibly linked to the study drug, researchers said. That patient experienced a retinal artery occlusion. All other adverse effects were said to be unrelated to the drug.

The researchers said patients who received treatment within their 6-month window had better visual acuity results than those who received treatment outside of that window. Additionally, they said, visual acuity outcomes for patients showing no observable reflux were better than for those whose procedures involved reflux.

Of 75 patients who received their treatment within the 6-month window and had no observable reflux, 43 patients (57.3%) were considered responders, with a loss of visual acuity of less than three lines. For patients who either missed the 6-month window or had reflux, only 38.1% responded as well.

The researchers found that lesion size, extent of disease and presence or absence of various lesion components play large roles in the results of the study.

Anecortave acetate has been recommended for regulatory approval in the United States. It is being developed by Alcon with the brand name Retaane.

The study is published in the January issue of Archives of Ophthalmology.