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

Sponsor

ONL Therapeutics (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05160805

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

12.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma	Drug: ONL1204 Ophthalmic solution (Dose A) Drug: ONL1204 Ophthalmic solution (Dose B) Procedure: Sham procedure	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group A ONL1204 Ophthalmic solution (Dose A) administered by intravitreal injection	Drug: ONL1204 Ophthalmic solution (Dose A) Liquid formulation administered by intravitreal (IVT) injection
Experimental: Treatment Group B ONL1204 Ophthalmic solution (Dose B) administered by intravitreal injection	Drug: ONL1204 Ophthalmic solution (Dose B) Liquid formulation administered by intravitreal (IVT) injection
Sham Comparator: Treatment Group C Sham procedure without penetrating the eye	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.

Arm

Intervention/Treatment

Experimental: Treatment Group A

ONL1204 Ophthalmic solution (Dose A) administered by intravitreal injection

Drug: ONL1204 Ophthalmic solution (Dose A)

Liquid formulation administered by intravitreal (IVT) injection

Experimental: Treatment Group B

ONL1204 Ophthalmic solution (Dose B) administered by intravitreal injection

Drug: ONL1204 Ophthalmic solution (Dose B)

Liquid formulation administered by intravitreal (IVT) injection

Sham Comparator: Treatment Group C

Sham procedure without penetrating the eye

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
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

Exclusion Criteria:

Considerations for either eye

Best Corrected Visual Acuity (BCVA) at Baseline 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

Other general exclusion criteria:

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