The first patient has been enrolled in a pivotal phase 3 clinical trial evaluating the safety and efficacy of an epithelium-on (epi-on) corneal collagen cross-linking procedure to treat progressive keratoconus.
Avedro Inc has announced that the first patient in its pivotal phase 3 clinical trial that is evaluating the safety and efficacy of an epithelium-on (epi-on) corneal collagen cross-linking procedure to treat progressive keratoconus has been enrolled.
“The start of this study is exciting news for patients,” said Mary Prudden, program director at the National Keratoconus Foundation in a recent statement. “We are pleased to see continued innovation in corneal cross-linking technologies and are hopeful that this research will ultimately lead to a second US Food and Drug Administration (FDA)-approved option for patients living with this rare and sight-threatening condition.”
ACP-KXL-308, the multicenter, randomized, controlled phase 3 clinical trial, seeks to evaluate a novel corneal cross-linking procedure of 275 patients with progressive keratoconus—a non-inflammatory eye condition characterized by a round dome-shaped cornea that progressively thins and weakens—across approximately 20 sites in the United States.
The primary outcome measures will include the mean difference of at least 1 diopter in corneal curvature (Kmax) change from baseline between treatment groups as measured in the time frame of 6 months. Secondary outcome measures will include the change from baseline in Kmax between treatment groups as measured in the time frame of 12 months.
“As a practitioner who has treated many patients with progressive keratoconus in previous clinical studies, the commencement of this epi-on cross-linking study represents another important milestone. This procedure, designed to eliminate the need to remove the epithelium, has the potential to be of great value to patients and practices alike,” added Michael B. Raizman, MD, clinical investigator and practicing ophthalmologist at Ophthalmic Consultants of Boston.
The trial will consist of two arms; for the experimental arm, referred to as the epithelium-on corneal collagen cross-linking (CXL) Treatment Group, patients will be administered Paracel 1 (2 drops every 60 seconds for 4 minutes), Paracel 2 R0185 (2 drops every 30 seconds for 6 minutes) and irradiated using KXL High Power System 10 J (30 mW/cm2 for 11 minutes 6 seconds with an on/off cycle of 1 second UVA on/1 second UVA off (total UVA dose of 10 J/cm2).
The control arm, referred to as the Sham Treatment/Control Group, will be administered Paracel Placebo (2 drops of Paracel Placebo every 60 seconds for 4 minutes followed by two drops every 30 seconds for 6 minutes) and KXL High Power System 2 J (6 mW/cm2 for 11 minutes 6 seconds with an on/off cycle of 1 second UVA on/1 second UVA off (total UVA dose of 2 J/cm2).
Massachusetts, Ohio, Utah, Pennsylvania, and Virginia compose the current list of participating study sites. The anticipated completion date for the trial is June 30, 2020.