Open Angle Glaucoma
Conditions
Keywords
Progressing, Glaucoma
Brief 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.
Interventions
DRUGONL1204 Ophthalmic solution (Dose A)
Liquid formulation administered by intravitreal (IVT) injection
DRUGONL1204 Ophthalmic solution (Dose B)
Liquid formulation administered by intravitreal (IVT) injection
PROCEDURESham 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.
Sponsors
ONL Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females aged ≥18 years old 2. Able and willing to give informed consent and attend study visits 3. Controlled intraocular pressure (IOP) (≤21 mmHg) in both eyes for all previous 3 visits before Screening and at Screening in both eyes 4. Prior to screening, 3 or more Humphrey Visual Field (HVF) tests (with acceptable reliability standards) or 3 or more Optical Coherence Tomography (OCT) studies of the study eye on record 5. Open angle glaucoma that is progressing in the study eye 6. HVF 24-2 at Screening with acceptable reliability standards and MD scores
Exclusion criteria
Considerations for either eye 1. Best Corrected Visual Acuity (BCVA) at Screening of ≤64 letters (Snellen equivalent of worse than 20/50) 2. Severe open angle glaucoma 3. Glaucoma due to non-open angle causes 4. Worse than mild non-proliferative diabetic retinopathy Considerations for study eye: 5. Visual field results suggestive of another disease (eg, altitudinal field defect) 6. Evidence of macular edema based on OCT imaging and Investigator's judgement 7. Previous intravitreal (IVT) injections, history of retinal surgery, history of retinal laser 8. Cataract surgery within 3 months of Screening or yttrium-aluminum-garnet capsulotomy (YAG) within 4 weeks of Screening 9. Anticipated need for surgical or procedural intervention for glaucoma, cataract, posterior capsular opacity, refractive error, or retinal conditions during the study Other general
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of ONL1204 as assessed by AE reporting and clinical evaluations | up to 39 weeks | Adverse event reporting, ophthalmic examination to evaluate the anterior and posterior segments of the eye, best-corrected visual acuity, intraocular pressure, electroretinogram, vital signs, clinical laboratory evaluations, and ophthalmic imaging results |
Countries
Australia, New Zealand
Outcome results
None listed