NCT05160805CompletedPhase 1
A Phase 1b Study of ONL1204 Ophthalmic Solution in Patients with Progressing Open Angle Glaucoma
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
Source: ClinicalTrials.gov · Last updated 29 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 6 Dec 2021
- Start date
- 2 May 2022
- Primary completion date
- 9 Apr 2024
- Lead sponsor
- ONL Therapeutics
- Diseases
- Glaucoma
- NCT number
- NCT05160805
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 25
- From 2 May 2022 to the primary completion date, 9 Apr 2024
- 11 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- The requirement for oral carbonic anhydrase inhibitors to control intraocular pressure
- 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)
Other illness
- Visual field results suggestive of another disease (eg, altitudinal field defect)
- 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:
- Severe, unstable, or uncontrolled cardiovascular, diabetic, renal, or pulmonary disease, based on Investigator's judgement
Other
- 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:
- Evidence of macular edema based on OCT imaging and 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Albury Eye Clinic Wodonga Coordinator of this site? Confirm its status | Albury | Australia | Unknown status |
| Armadale Eye Clinic Coordinator of this site? Confirm its status | Armadale | Australia | Unknown status |
| Melbourne Eye Specialists Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| North West Eye Specialists Coordinator of this site? Confirm its status | Gladstone Park | Australia | Unknown status |
| Sydney Eye Surgeons Coordinator of this site? Confirm its status | Hurstville | Australia | Unknown status |
| Centre for Eye Research Australia (CERA) Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| PersonalEYES Coordinator of this site? Confirm its status | Parramatta | Australia | Unknown status |
| Eye Associates Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| Waverely Eye Clinic Coordinator of this site? Confirm its status | Waverley | Australia | Unknown status |
| Eye Institute Limited Coordinator of this site? Confirm its status | Remuera | New Zealand | Unknown status |
| Capital Eye Specialists Coordinator of this site? Confirm its status | Wellington | New Zealand | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.