Clinical trial NCT05160805: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Open Angle Glaucoma
Keywords: Progressing
Glaucoma
Lead sponsor: ONL Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-12-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Safety and Tolerability of ONL1204 as assessed by AE reporting and clinical evaluations
timeFrame: up to 39 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Albury
country: Australia
facility: Albury Eye Clinic Wodonga
state: New South Wales
city: Hurstville
country: Australia
facility: Sydney Eye Surgeons
state: New South Wales
city: Parramatta
country: Australia
facility: PersonalEYES
state: New South Wales
city: Sydney
country: Australia
facility: Eye Associates
state: New South Wales
city: Armadale
country: Australia
facility: Armadale Eye Clinic
state: Victoria
city: Fitzroy
country: Australia
facility: Melbourne Eye Specialists
state: Victoria
city: Gladstone Park
country: Australia
facility: North West Eye Specialists
state: Victoria
city: Melbourne
country: Australia
facility: Centre for Eye Research Australia (CERA)
state: Victoria
city: Waverley
country: Australia
facility: Waverely Eye Clinic
state: Victoria
city: Remuera
country: New Zealand
facility: Eye Institute Limited
state: Auckland
city: Wellington
country: New Zealand
facility: Capital Eye Specialists
Study officials:
References: