A Phase 1b Study of ONL1204 Ophthalmic Solution in Patients with Progressing Open Angle Glaucoma
NCT ID: NCT05160805
Last Updated: 2024-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2022-05-02
2024-04-09
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Treatment Group A
ONL1204 Ophthalmic solution (Dose A) administered by intravitreal injection
ONL1204 Ophthalmic solution (Dose A)
Liquid formulation administered by intravitreal (IVT) injection
Treatment Group B
ONL1204 Ophthalmic solution (Dose B) administered by intravitreal injection
ONL1204 Ophthalmic solution (Dose B)
Liquid formulation administered by intravitreal (IVT) injection
Treatment Group C
Sham procedure without penetrating the eye
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.
Interventions
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ONL1204 Ophthalmic solution (Dose A)
Liquid formulation administered by intravitreal (IVT) injection
ONL1204 Ophthalmic solution (Dose B)
Liquid formulation administered by intravitreal (IVT) injection
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.
Eligibility Criteria
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Inclusion Criteria
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
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
10. The requirement for oral carbonic anhydrase inhibitors to control intraocular pressure
11. Severe, unstable, or uncontrolled cardiovascular, diabetic, renal, or pulmonary disease, based on Investigator's judgement
12. Systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg
13. Women who are pregnant, breastfeeding, or contemplating pregnancy during the study period and men who are contemplating contributing sperm for a biologic child during the study period
14. Participation in other ophthalmic clinical trials or use of any other investigational drugs or devices in either eye or systemically for 3 months before Screening (Visit 1)
18 Years
ALL
No
Sponsors
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ONL Therapeutics
INDUSTRY
Responsible Party
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Locations
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Albury Eye Clinic Wodonga
Albury, New South Wales, Australia
Sydney Eye Surgeons
Hurstville, New South Wales, Australia
PersonalEYES
Parramatta, New South Wales, Australia
Eye Associates
Sydney, New South Wales, Australia
Armadale Eye Clinic
Armadale, Victoria, Australia
Melbourne Eye Specialists
Fitzroy, Victoria, Australia
North West Eye Specialists
Gladstone Park, Victoria, Australia
Centre for Eye Research Australia (CERA)
Melbourne, Victoria, Australia
Waverely Eye Clinic
Waverley, Victoria, Australia
Eye Institute Limited
Remuera, Auckland, New Zealand
Capital Eye Specialists
Wellington, Wellington Region, New Zealand
Countries
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Related Links
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ONL Therapeutics corporate website
Other Identifiers
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ONL1204-OAG-001
Identifier Type: -
Identifier Source: org_study_id
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