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

Phase 1

Completed

• Conditions: Open Angle Glaucoma
• Interventions: Drug: ONL1204 Ophthalmic solution (Dose A); Drug: ONL1204 Ophthalmic solution (Dose B); Procedure: Sham procedure

• Registration Number: NCT05160805
• Lead Sponsor: ONL Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2021-12-06
• Study First Posted: 2021-12-16
• Study Start: 2022-05-02
• Primary Completion: 2024-04-09
• Study Completion: 2024-04-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-26
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 exclusion criteria:

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group A	ONL1204 Ophthalmic solution (Dose A)	ONL1204 Ophthalmic solution (Dose A) administered by intravitreal injection
Treatment Group B	ONL1204 Ophthalmic solution (Dose B)	ONL1204 Ophthalmic solution (Dose B) administered by intravitreal injection
Treatment Group C	Sham procedure	Sham procedure without penetrating the eye

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (11)

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

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