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TTT follow-up data mirrors earlier results

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MOUNTAIN VIEW, Calif. — Transpupillary thermotherapy was associated with a significant clinical benefit in a subgroup of patients with wet age-related macular degeneration in a clinical trial comparing the laser treatment to sham treatment, according to Elias Reichel, MD.

Preliminary results of the trial in 60 patients were released in February, Dr. Reichel said at the Association for Research in Vision and Ophthalmology meeting last week. He updated the results to include 305 patients who have reached the 18-month follow-up point. These results confirm the earlier ones, according to a press release from Iridex, the sponsor of the trial.

The TTT4CNV Clinical Trial compared treatment with transpupillary thermotherapy (TTT) with a sham placebo treatment. As in the earlier results, a subgroup of patients in the TTT4CNV trial with a baseline visual acuity of 20/100 or worse demonstrated a benefited from TTT as compared with placebo. About 41% of the patients enrolled in the trial had a baseline vision of 20/100 or worse, according to a press release from Iridex.

At 12 months following treatment, 23% of the eyes treated with TTT in this subgroup showed improvement of vision by one or more lines, and 14% of eyes treated with TTT showed improvement of vision by three or more lines. No eyes in the placebo group showed improvement.

At the 18 month follow-up, there was a two-line benefit in preserving vision in this subgroup compared with the placebo-treated eyes, according to Iridex. On average, eyes treated with TTT lost two lines of visual acuity while those on placebo lost four lines. These differences were statistically significant, according to the company.

“These less-than-or-equal-to-20/100 subgroup findings indicated that TTT is beneficial compared to natural history in eyes with subfoveal occult choroidal neovascularization and best-corrected visual acuity of 20/100 or worse,” Dr. Reichel said in the press release.