NCT05160805

A Phase 1b Study of ONL1204 Ophthalmic Solution in Patients with Progressing Open Angle Glaucoma

A Phase 1b Multicenter, Randomized, Single-Masked, Sham-Controlled Study of the Safety and Tolerability of ONL1204 Ophthalmic Solution in Patients with Progressing Open Angle Glaucoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: ONL Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the safety and tolerability of ONL1204 Ophthalmic Solution in patients with progressing open angle glaucoma. ONL1204 Ophthalmic Solution is a first-in-class inhibitor of fragment apoptosis stimulator (Fas) receptor-mediated cell death that has demonstrated protection of multiple retinal cell types in numerous preclinical models of retinal disease. Apoptosis of retinal ganglion cells is associated with progressive glaucoma. Nonclinical data on ONL1204 Ophthalmic Solution suggest that ONL1204 Ophthalmic Solution may inhibit the cell death pathways in these cells.

Conditions

• Open Angle Glaucoma

Interventions

Type	Name	Description
DRUG	ONL1204 Ophthalmic solution (Dose A)	Liquid formulation administered by intravitreal (IVT) injection
DRUG	ONL1204 Ophthalmic solution (Dose B)	Liquid formulation administered by intravitreal (IVT) injection
PROCEDURE	Sham procedure	A sham procedure looks like a real injection into the eye but does not penetrate the eye and it does not have any study drug. The procedure is done by touching the eye surface with a syringe without a needle.

Timeline

• Start date: 2022-05-02
• Primary completion: 2024-04-09
• Completion: 2024-04-09
• First posted: 2021-12-16
• Last updated: 2024-10-29

Locations

11 sites across 2 countries: Australia, New Zealand