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

NCT05160805 | Completed Phase 1 DMC

• 1 other identifier: ONL1204-OAG-001
• Study Type: interventional
• Target: 25
• Locations: 2 countries
• Sites: 11

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.

Conditions

Open Angle Glaucoma

Keywords

Progressing; Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Treatment Group A

EXPERIMENTAL

ONL1204 Ophthalmic solution (Dose A) administered by intravitreal injection

Drug: ONL1204 Ophthalmic solution (Dose A)

Treatment Group B

EXPERIMENTAL

ONL1204 Ophthalmic solution (Dose B) administered by intravitreal injection

Drug: ONL1204 Ophthalmic solution (Dose B)

Treatment Group C

SHAM COMPARATOR

Sham procedure without penetrating the eye

Procedure: Sham procedure

Interventions

ONL1204 Ophthalmic solution (Dose A) DRUG

Liquid formulation administered by intravitreal (IVT) injection

Treatment Group A

ONL1204 Ophthalmic solution (Dose B) DRUG

Liquid formulation administered by intravitreal (IVT) injection

Treatment Group B

Sham procedure 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.

Treatment Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged ≥18 years old
• Able and willing to give informed consent and attend study visits
• Controlled intraocular pressure (IOP) (≤21 mmHg) in both eyes for all previous 3 visits before Screening and at Screening in both eyes
• 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
• Open angle glaucoma that is progressing in the study eye
• HVF 24-2 at Screening with acceptable reliability standards and MD scores

You may not qualify if:

• Considerations for either eye
• Best Corrected Visual Acuity (BCVA) at Screening of ≤64 letters (Snellen equivalent of worse than 20/50)
• Severe open angle glaucoma
• Glaucoma due to non-open angle causes
• Worse than mild non-proliferative diabetic retinopathy
• Considerations for study eye:
• Visual field results suggestive of another disease (eg, altitudinal field defect)
• Evidence of macular edema based on OCT imaging and Investigator's judgement
• Previous intravitreal (IVT) injections, history of retinal surgery, history of retinal laser
• Cataract surgery within 3 months of Screening or yttrium-aluminum-garnet capsulotomy (YAG) within 4 weeks of Screening
• Anticipated need for surgical or procedural intervention for glaucoma, cataract, posterior capsular opacity, refractive error, or retinal conditions during the study
• The requirement for oral carbonic anhydrase inhibitors to control intraocular pressure
• Severe, unstable, or uncontrolled cardiovascular, diabetic, renal, or pulmonary disease, based on Investigator's judgement
• Systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg
• 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

Sponsors & Collaborators

• ONL Therapeutics: lead

Study Sites (11)

Albury Eye Clinic Wodonga

Albury, New South Wales, 2640, Australia

Location

Sydney Eye Surgeons

Hurstville, New South Wales, 2220, Australia

Location

PersonalEYES

Parramatta, New South Wales, 2150, Australia

Location

Eye Associates

Sydney, New South Wales, 2000, Australia

Location

Armadale Eye Clinic

Armadale, Victoria, 3143, Australia

Location

Melbourne Eye Specialists

Fitzroy, Victoria, 3065, Australia

Location

North West Eye Specialists

Gladstone Park, Victoria, 3403, Australia

Location

Centre for Eye Research Australia (CERA)

Melbourne, Victoria, 3002, Australia

Location

Waverely Eye Clinic

Waverley, Victoria, 3150, Australia

Location

Eye Institute Limited

Remuera, Auckland, 1050, New Zealand

Location

Capital Eye Specialists

Wellington, Wellington Region, 6011, New Zealand

Location

Related Links

• ONL Therapeutics corporate website

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 16, 2021
• Study Start: May 2, 2022
• Primary Completion: April 9, 2024
• Study Completion: April 9, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (9); NZ (2)