Clinical Trials Logo
  1. Home
  2. Geographic Atrophy
  3. NCT04744662

ONL1204 Ophthalmic Solution in Patients With Geographic Atrophy Associated With Age-related Macular Degeneration

Geographic Atrophy Clinical Trial

Official title:
A Phase 1b Multicenter, Randomized, Controlled, Single-dose Study of the Safety and Tolerability of ONL1204 Ophthalmic Solution in Patients With Geographic Atrophy (GA) Associated With Age-related Macular Degeneration (AMD

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of intravitreal injection of ONL1204 Ophthalmic Solution in patients with geographic atrophy associated with AMD. GA associated with AMD is one of the world's leading causes of visual disability. It is a progressive disease with no approved therapy to slow or arrest the process of continual photoreceptor and retinal epithelial (RPE) cell loss. A safe and effective therapy for GA will have vast societal benefits. ONL1204 is being developed for this purpose. ONL1204 is a first-in-class inhibitor of fragment apoptosis stimulator receptor-mediated cell death in development for to reduce rates of vision in patients with GA associated with AMD. ONL1204 has demonstrated protection of multiple retinal cell types in several preclinical models of acute ocular injury and the protection of RPE in AMD models. ONL1204 Ophthalmic Solution is currently in a Phase 1 clinical study in patients with macula-off retinal detachment to evaluate safety and tolerability of a single-dose of ONL1204 Ophthalmic Solution. The study is ongoing and uses the same doses and route of administration as this Phase 1b study in patients with GA.

Clinical Trial Description

In this study patients will be enrolled and followed for 24 weeks (natural history phase) at which point they will be randomized to 1 of 2 doses of ONL1204 Ophthalmic Solution or sham. Weeks 24 to 48 make up the Treatment Phase. Patients will be on study for a total of 48 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04744662
Study type Interventional
Source ONL Therapeutics
Contact
Status Completed
Phase Phase 1
Start date July 8, 2021
Completion date February 29, 2024
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT06161584 - A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Active, not recruiting NCT05536297 - Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy Phase 3
Completed NCT02515942 - CLG561 Proof-of-Concept Study as a Monotherapy and in Combination With LFG316 in Subjects With Geographic Atrophy (GA) Phase 2
Completed NCT02503332 - Study of Pegcetacoplan (APL-2) Therapy in Patients With Geographic Atrophy Phase 2
Recruiting NCT04339764 - Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration Phase 1/Phase 2
Completed NCT03295877 - Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) Phase 1
Completed NCT01445548 - Sirolimus for Advanced Age-Related Macular Degeneration Phase 1/Phase 2
Completed NCT00973011 - A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy Phase 1
Terminated NCT02247479 - A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration Phase 3
Active, not recruiting NCT06006585 - A Study to Test How Well Different Doses of BI 771716 Are Tolerated by People With an Advanced Form of Age-related Macular Degeneration (AMD) Called Geographic Atrophy Phase 1
Recruiting NCT05961332 - COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy N/A
Terminated NCT02247531 - A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration Phase 3
Completed NCT02332343 - Sparing of the Fovea in Geographic Atrophy Progression N/A
Completed NCT01002950 - Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects With Geographic Atrophy Phase 2
Completed NCT03777332 - Study to Evaluate the Safety of Intravitreal APL-2 in Patients Diagnosed With Geographic Atrophy Phase 1
Active, not recruiting NCT04676854 - Restoration of Central Vision With the PRIMA System in Patients With Atrophic AMD N/A
Recruiting NCT02372916 - Geographic Atrophy and Intravitreal Ranibizumab Injections N/A
Active, not recruiting NCT05380492 - Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration Phase 1/Phase 2
Terminated NCT04607148 - A Study Assessing the Long-Term Safety and Tolerability of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration Phase 2
Terminated NCT02087085 - A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration Phase 2