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

Open Angle Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05160805
• Other study ID #: ONL1204-OAG-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: May 2, 2022
• Est. completion date: October 2024

Study information

• Verified date: July 2023
• Source: ONL Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: October 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma

Intervention

Drug:
• ONL1204 Ophthalmic solution (Dose A)
Liquid formulation administered by intravitreal (IVT) injection
• 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.

Locations

Country	Name	City	State
Australia	Albury Eye Clinic Wodonga	Albury	New South Wales
Australia	Armadale Eye Clinic	Armadale	Victoria
Australia	Melbourne Eye Specialists	Fitzroy	Victoria
Australia	North West Eye Specialists	Gladstone Park	Victoria
Australia	Sydney Eye Surgeons	Hurstville	New South Wales
Australia	Centre for Eye Research Australia (CERA)	Melbourne	Victoria
Australia	PersonalEYES	Parramatta	New South Wales
Australia	Eye Associates	Sydney	New South Wales
Australia	Waverely Eye Clinic	Waverley	Victoria
New Zealand	Eye Institute Limited	Remuera	Auckland
New Zealand	Capital Eye Specialists	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
ONL Therapeutics

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of ONL1204 as assessed by AE reporting and clinical evaluations	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	up to 39 weeks

External Links

•   ONL Therapeutics corporate website