A Study to Evaluate the Safety and Tolerability of ONL1204 in Patients With Macula-off, Rhegmatogenous Retinal Detachment
Status:
Recruiting
Trial end date:
2022-03-31
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the safety and tolerability of ONL1204 in
participants with Macula-off, Rhegmatogenous Retinal Detachment (RRD). RRD is an acute and
serious vision threatening condition in which a tear in the retina, typically resulting from
a vitreous detachment, allows liquid to accumulate under the retina, detaching the
photoreceptor (PR) layer of the retina from the retinal pigment epithelium (RPE). As the RPE
is the principal source of nutritional support for the PR layer, the photoreceptors begin a
cascade of inflammation and cell death. Photoreceptor cell death is the primary mechanism of
vision loss after retinal detachment.
ONL1204 is a first-in-class inhibitor of Fragment Apoptosis Stimulator receptor
(Fas)-mediated cell death. ONL1204 has demonstrated protection of multiple retinal cell types
in numerous preclinical models of acute ocular injury. This will be a first-in-human (FIH)
study to evaluate safety and tolerability of a single-dose of ONL1204 in participants with
macula-off RRD. The standard of care for surgical repair of macula-off RRD is reattachment
surgery within 7 days of the macula detaching. Participants in this study will receive a
single intravitreal injection upon diagnosis and enrollment in the study, followed by
standard of care surgery. The surgery includes vitrectomy, a procedure that removes the bulk
of drug remaining in the vitreous.