Open Angle GlaucomaPhase 1NCT05160805
A Phase 1b Study of ONL1204 Ophthalmic Solution in Patients with Progressing Open Angle Glaucoma
A Phase 1 study testing ONL1204 Ophthalmic solution (Dose A) and ONL1204 Ophthalmic solution (Dose B) in people with Open Angle Glaucoma, run by ONL Therapeutics at 11 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- ONL1204 Ophthalmic solution (Dose A) and ONL1204 Ophthalmic solution (Dose B)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 2 May 2022to 9 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
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- 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)
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Australia9 sites
Albury Eye Clinic Wodonga
Albury, New South Wales, 2640
Armadale Eye Clinic
Armadale, Victoria, 3143
Melbourne Eye Specialists
Fitzroy, Victoria, 3065
North West Eye Specialists
Gladstone Park, Victoria, 3403
Sydney Eye Surgeons
Hurstville, New South Wales, 2220
Centre for Eye Research Australia (CERA)
Melbourne, Victoria, 3002
PersonalEYES
Parramatta, New South Wales, 2150
Eye Associates
Sydney, New South Wales, 2000
Waverely Eye Clinic
Waverley, Victoria, 3150
New Zealand2 sites
Eye Institute Limited
Remuera, Auckland, 1050
Capital Eye Specialists
Wellington, Wellington Region, 6011
About this study
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
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
- Being tested
- ONL1204 Ophthalmic solution (Dose A), ONL1204 Ophthalmic solution (Dose B), Sham procedure
- Keywords
- Progressing, Glaucoma
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 procedureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Experimental | ONL1204 Ophthalmic solution (Dose A) administered by intravitreal injection Receives: Drug: ONL1204 Ophthalmic solution (Dose A) |
| Treatment Group B | Experimental | ONL1204 Ophthalmic solution (Dose B) administered by intravitreal injection Receives: Drug: ONL1204 Ophthalmic solution (Dose B) |
| Treatment Group C | Sham comparator | Sham procedure without penetrating the eye Receives: Procedure: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 39 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start2 May 2022
- Primary completion9 Apr 2024
- Study completion9 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- ONL Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160805
- Sponsor's protocol ID
- ONL1204-OAG-001
- Status last verified
- Oct 2024
- First submitted
- 6 Dec 2021
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05160805
- Acronym / sponsor ID
- ONL1204-OAG-001
- Conditions
- Open Angle Glaucoma
- Keywords
- Progressing, Glaucoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- ONL TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 2 May 2022 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Experimental | Drug: ONL1204 Ophthalmic solution (Dose A)ONL1204 Ophthalmic solution (Dose A) administered by intravitreal injection |
| Treatment Group B | Experimental | Drug: ONL1204 Ophthalmic solution (Dose B)ONL1204 Ophthalmic solution (Dose B) administered by intravitreal injection |
| Treatment Group C | Sham comparator | Procedure: Sham procedureSham procedure without penetrating the eye |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONL1204 Ophthalmic solution (Dose A)Liquid formulation administered by intravitreal (IVT) injection | Drug | Treatment Group A |
| ONL1204 Ophthalmic solution (Dose B)Liquid formulation administered by intravitreal (IVT) injection | Drug | Treatment Group B |
| Sham procedureA 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. | Procedure or surgery | Treatment Group C |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- ONL Therapeutics corporate websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONL1204 Ophthalmic solution (Dose A) and ONL1204 Ophthalmic solution (Dose B) in people with Open Angle Glaucoma, run by ONL Therapeutics at 11 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of ONL1204 as assessed by AE reporting and clinical evaluations (time frame: up to 39 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.