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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05160805




Registration number
NCT05160805
Ethics application status
Date submitted
6/12/2021
Date registered
16/12/2021
Date last updated
29/10/2024

Titles & IDs
Public title
A Phase 1b Study of ONL1204 Ophthalmic Solution in Patients with Progressing Open Angle Glaucoma
Scientific 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
Secondary ID [1] 0 0
ONL1204-OAG-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Open Angle Glaucoma 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ONL1204 Ophthalmic solution (Dose A)
Treatment: Drugs - ONL1204 Ophthalmic solution (Dose B)
Treatment: Surgery - Sham procedure

Experimental: Treatment Group A - ONL1204 Ophthalmic solution (Dose A) administered by intravitreal injection

Experimental: Treatment Group B - ONL1204 Ophthalmic solution (Dose B) administered by intravitreal injection

Sham comparator: Treatment Group C - Sham procedure without penetrating the eye


Treatment: Drugs: ONL1204 Ophthalmic solution (Dose A)
Liquid formulation administered by intravitreal (IVT) injection

Treatment: Drugs: ONL1204 Ophthalmic solution (Dose B)
Liquid formulation administered by intravitreal (IVT) injection

Treatment: Surgery: Sham 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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability of ONL1204 as assessed by AE reporting and clinical evaluations
Timepoint [1] 0 0
up to 39 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/04/2024
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Albury Eye Clinic Wodonga - Albury
Recruitment hospital [2] 0 0
Sydney Eye Surgeons - Hurstville
Recruitment hospital [3] 0 0
PersonalEYES - Parramatta
Recruitment hospital [4] 0 0
Eye Associates - Sydney
Recruitment hospital [5] 0 0
Armadale Eye Clinic - Armadale
Recruitment hospital [6] 0 0
Melbourne Eye Specialists - Fitzroy
Recruitment hospital [7] 0 0
North West Eye Specialists - Gladstone Park
Recruitment hospital [8] 0 0
Centre for Eye Research Australia (CERA) - Melbourne
Recruitment hospital [9] 0 0
Waverely Eye Clinic - Waverley
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2220 - Hurstville
Recruitment postcode(s) [3] 0 0
2150 - Parramatta
Recruitment postcode(s) [4] 0 0
2000 - Sydney
Recruitment postcode(s) [5] 0 0
3143 - Armadale
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3403 - Gladstone Park
Recruitment postcode(s) [8] 0 0
3002 - Melbourne
Recruitment postcode(s) [9] 0 0
3150 - Waverley
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ONL Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05160805
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05160805