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

Primary Purpose

Open Angle Glaucoma

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ONL1204 Ophthalmic solution (Dose A)
ONL1204 Ophthalmic solution (Dose B)
Sham procedure
Sponsored by
ONL Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Progressing, Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Albury Eye Clinic Wodonga
  • Sydney Eye Surgeons
  • PersonalEYES
  • Eye Associates
  • Armadale Eye Clinic
  • Melbourne Eye Specialists
  • North West Eye Specialists
  • Centre for Eye Research Australia (CERA)
  • Waverely Eye Clinic
  • Eye Institute Limited
  • Capital Eye Specialists

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Treatment Group A

Treatment Group B

Treatment Group C

Arm Description

ONL1204 Ophthalmic solution (Dose A) administered by intravitreal injection

ONL1204 Ophthalmic solution (Dose B) administered by intravitreal injection

Sham procedure without penetrating the eye

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 6, 2021
Last Updated
July 13, 2023
Sponsor
ONL Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05160805
Brief Title
A Phase 1b Study of ONL1204 Ophthalmic Solution in Patients With Progressing Open Angle Glaucoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ONL Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma
Keywords
Progressing, Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group A
Arm Type
Experimental
Arm Description
ONL1204 Ophthalmic solution (Dose A) administered by intravitreal injection
Arm Title
Treatment Group B
Arm Type
Experimental
Arm Description
ONL1204 Ophthalmic solution (Dose B) administered by intravitreal injection
Arm Title
Treatment Group C
Arm Type
Sham Comparator
Arm Description
Sham procedure without penetrating the eye
Intervention Type
Drug
Intervention Name(s)
ONL1204 Ophthalmic solution (Dose A)
Intervention Description
Liquid formulation administered by intravitreal (IVT) injection
Intervention Type
Drug
Intervention Name(s)
ONL1204 Ophthalmic solution (Dose B)
Intervention Description
Liquid formulation administered by intravitreal (IVT) injection
Intervention Type
Procedure
Intervention Name(s)
Sham procedure
Intervention Description
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 Outcome Measure Information:
Title
Safety and Tolerability of ONL1204 as assessed by AE reporting and clinical evaluations
Description
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
Time Frame
up to 39 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Albury Eye Clinic Wodonga
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
Facility Name
Sydney Eye Surgeons
City
Hurstville
State/Province
New South Wales
ZIP/Postal Code
2220
Country
Australia
Facility Name
PersonalEYES
City
Parramatta
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Facility Name
Eye Associates
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Armadale Eye Clinic
City
Armadale
State/Province
Victoria
ZIP/Postal Code
3143
Country
Australia
Facility Name
Melbourne Eye Specialists
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
North West Eye Specialists
City
Gladstone Park
State/Province
Victoria
ZIP/Postal Code
3403
Country
Australia
Facility Name
Centre for Eye Research Australia (CERA)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Waverely Eye Clinic
City
Waverley
State/Province
Victoria
ZIP/Postal Code
3150
Country
Australia
Facility Name
Eye Institute Limited
City
Remuera
State/Province
Auckland
ZIP/Postal Code
1050
Country
New Zealand
Facility Name
Capital Eye Specialists
City
Wellington
ZIP/Postal Code
6011
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.onltherapeutics.com/clinical-trials/
Description
ONL Therapeutics corporate website

Learn more about this trial

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

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