No difference between Macugen and triamcinolone

June 14, 2007

A study, which was halted before the completion of enrolment, failed to demonstrate any difference in the visual outcomes or safety concerns in patients with neovascularization secondary to age-related macular degeneration (AMD) who were treated with photodynamic therapy (PDT) in combination with either intravitreal injections of Macugen (pegaptanib sodium) or triamcinolone

A study, which was halted before the completion of enrolment, failed to demonstrate any difference in the visual outcomes or safety concerns in patients with neovascularization secondary to age-related macular degeneration (AMD) who were treated with photodynamic therapy (PDT) in combination with either intravitreal injections of Macugen (pegaptanib sodium) or triamcinolone, according to a presentation at this year's meeting of the Association for Research in Vision and Ophthalmology (ARVO).

Peter Kaiser from the Cole Eye Institute, Ohio, USA presented the findings of the study in which patients were randomized to receive either PDT plus pegaptanib sodium 0.3 mg (n=38), PDT plus triamcinolone 1 mg (n=32) or triamcinolone 4 mg (n=41). The study was halted early, with only 111 patients of the intended 339 taking part.

After six-months follow-up there were no significant differences between groups in terms of the primary endpoint - a loss of 15 letters on the visual acuity test. All percentages were much lower than had been expected (PDT plus pegaptanib sodium 73.7%; PDT plus triamcinolone 81.3%; triamcinolone 73.2%). There was also no significant difference in the area of neovascularization between the two steroid groups and the pegaptanib sodium group. All groups demonstrated a significant reduction in central retinal thickness.

In terms of safety, 14% of patients receiving triamcinolone had significant spikes in their intraocular pressure, although it did not result in any acute losses in visual acuity. Overall the safety was considered to be reasonably good in each group.

Despite the early termination of enrolment, patients will continue treatment until the 12-month endpoint.