Ampio Pharmaceuticals announced it will halt enrollment to the OptimEyes Study with fewer participants than originally intended, citing early positive responses to ultra–low-dose danazol for the treatment of diabetic macular edema, according to a company press release.
The Transplant and Ophthalmology Division of the U.S. Food and Drug Administration has been notified of the changes, which will reduce enrollment from 450 patients powered at 95% to the present enrollment of more than 355 patients, providing a power of 88%, according to the press release.
“The decision to reduce the sample size of the trial took into consideration requests from … site investigators, asking to extend the open-label enrollment portion (where all patients receive active drug dose) of the trial beyond the 12 weeks allowed for in the protocol,” Vaughan Clift, chief medical officer of Ampio, said in the press release. “These clinicians believed that their patients were improving while on the active drug and subsequently regressed quickly once they completed the open-label phase.”
Enrollment in the open-label extension phase was much higher than expected, Clift stated. As a result, the company felt it was in patients’ best interest to analyze the data as soon as possible to confirm any observed benefits.
As a result of the reduced patient sample size, data are expected by the fourth quarter of this year, according to the release.
For more information:
ClinicalTrials.gov identifier: NCT01821677.