The prospective randomised Phase 2 trial enrolled 184 patients who were randomised to receive three dose levels of PF-04523655 (0.4mg, 1mg, and 3mg) or laser photocoagulation control – the current standard of care.
The endpoint of the study was defined as mean visual acuity improvements over baseline at 24 months.
Interim results at 12 months revealed that there were no drug related Serious Adverse Events (SAEs).
After 12 months of treatment with PF-04523655, a dose dependent improvement in visual acuity was observed with the best results achieved at the 3mg dose level.
The study was terminated at 12 months based on the interim analysis which suggested that higher doses would be necessary to produce a therapeutic effect sufficiently superior to the current standard of care.
Based on these results, Quark and Pfizer have agreed that Quark will test higher doses of PF-04523655 and determine the optimal dose for pivotal Phase 3 studies.
The Phase 2b study will be a randomised, dose ranging comparator study that will evaluate the safety and efficacy of PF-04523655 (RTP801I-14) versus Lucentis.
The study will enroll 225 patients with diabetic macular edema.