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OpenTrials
Completed

NCT Number: NCT05160805

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

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.

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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Albury Eye Clinic Wodonga, Albury, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Exclusion criteria

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

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
  • 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)

Treatment and study plan

ONL1204 Ophthalmic solution (Dose A)

Drug

Liquid formulation administered by intravitreal (IVT) injection

ONL1204 Ophthalmic solution (Dose B)

Drug

Liquid formulation administered by intravitreal (IVT) injection

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.

Primary outcomes

  1. Safety and Tolerability of ONL1204 as assessed by AE reporting and clinical evaluations

    Time frame: 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

Sponsors and collaborators

Lead sponsor

ONL Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 16, 2021
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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