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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Injection of study drug into the eye
vitreous and aqueous fluid collection by a tap and during vitrectomy
Save Sight Institute, Sydney Eye Hospital
Sydney, New South Wales, Australia
Royal Adelaide
Melbourne, Victoria, Australia
Queensland Eye Institute
Melbourne, Victoria, Australia
Center for Eye Rearch Australia
Melbourne, Victoria, Australia
Adverse Event (AE) Reporting
AEs restricted to treatment-emergent AEs (TEAEs) only. Ocular and non-ocular AEs reported separately. See AE Reporting Table for descriptive ocular and non-ocular AE findings.
Time frame: 24 weeks
BCVA (LogMAR) at Final Study Visit
BCVA was performed in the study eye using ETDRS methodology and letters read were converted to a logMAR value using the following equation: logMAR = -0.02 × ETDRS + 1.7.
Time frame: 24 weeks
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