Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001357842p
Ethics application status
Submitted, not yet approved
Date submitted
11/08/2021
Date registered
7/10/2021
Date last updated
14/06/2022
Date data sharing statement initially provided
7/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A phase II open label study to determine the ocular pharmacokinetics of oral OCX063.
Scientific title
A phase II open label study to determine the ocular pharmacokinetics of oral OCX063, in patients requiring retinal reattachment surgery.
Secondary ID [1] 305024 0
OCC-OCX063-oPK01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Retinal detachment 323196 0
Condition category
Condition code
Eye 320778 320778 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The first 6 patients will receive a loading dose of oral OCX063 400mg on Day 1 approximately 3 hours prior to surgery then 200mg oral OCX063 once daily for 7 days (8 days total treatment). Compliance assessed by returned capsule count.
Intervention code [1] 321421 0
Treatment: Drugs
Comparator / control treatment
The second 6 patients will receive a loading dose of oral OCX063 800mg on Day 1 approximately 3 hours prior to surgery then 400mg oral OCX063 once daily for 7 days (8 days total treatment). Compliance assessed by returned capsule count.
Control group
Dose comparison

Outcomes
Primary outcome [1] 328590 0
Levels of OCX063 in vitreous humour (sample collected during surgery)
Timepoint [1] 328590 0
On Day 1 approximately 3 hours after loading dose
Primary outcome [2] 328591 0
Levels of OCX063 in aqueous humour (D1 sample collected during surgery and D8 sample collected via aqueous tap)
Timepoint [2] 328591 0
On Day 1 approximately 3 hours after loading dose and on Day 8 approximately 3 hours after final dose
Secondary outcome [1] 399555 0
Safety as assessed by occurrence of adverse events as per ICH GCP and protocol definitions
Timepoint [1] 399555 0
Throughout study period
Secondary outcome [2] 401412 0
Safety assessed by biochemistry, haematology, and coagulation laboratory values
Timepoint [2] 401412 0
Day 8 compared to baseline

Eligibility
Key inclusion criteria
- Provide written informed consent prior to any study procedures and who agree to adhere to all protocol requirements.
- Aged 18 years or older at the time of consent.
- Participants must agree to use contraception according to protocol
- Require pars plana vitrectomy with or without scleral buckling due to retinal detachment due to any cause.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or breast-feeding.
- Have received any investigational medicinal product (IMP) within 30 days or 5 half-lives prior to dosing (4 months if the previous drug was a new chemical entity), whichever is longer.
- Have known or suspected contraindications to the IMP.
- Have undergone other ocular surgery performed within 6 months prior to screening or planned during the trial in the study eye, with the exception of uncomplicated cataract surgery which is allowed in the month prior.
- Have any additional eye disease in the study eye that, in the opinion of the investigator, could compromise or alter visual acuity during the course of the study (e.g. vein occlusion, uncontrolled intraocular pressure (IOP) greater than 24 mmHg on optimal medical treatment, glaucoma with visual field loss, uveitis or other ocular inflammatory or infectious disease, monocular vision, history of ischemic optic neuropathy, intraocular foreign body, sickle cell disease, or genetic disorders such as retinitis pigmentosa)
- Aphakia or Posterior-chamber Intraocular Lens Implantation with known ruptured capsule other than prior uncomplicated yttrium-aluminum-garnet (YAG) laser treatment.
- Have anterior segment or vitreous abnormalities in the study eye that would compromise adequate assessment of tissue compartments.
- Currently using or plan to use, during the trial, medications known to be toxic to the retina, lens or optic nerve, or cause vision loss.
- Wish to continue the intake of other restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- Have a diagnosis of a serious or unstable systemic or eye disease and other conditions that, in the clinical judgment of the investigator, are likely to interfere with the analyses of safety and efficacy in this study. Patients with an expected life expectancy of less than 2 years are also excluded.
- Other than requiring retinal repair, have any other medical condition or significant co-morbidities, clinically relevant social or psychiatric conditions, or any finding during Screening, which in the investigator’s opinion may put the subject at risk or interfere with the study objectives.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Sequential cohorts
Phase
Phase 1 / Phase 2
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Company decision
Date of first participant enrolment
Anticipated
1/12/2021
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 309411 0
Commercial sector/Industry
Name [1] 309411 0
OccuRx Pty Ltd
Country [1] 309411 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
OccuRx Pty Ltd
Address
Level 9, 31 Queen St
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 310382 0
None
Name [1] 310382 0
None
Address [1] 310382 0
NA
Country [1] 310382 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309215 0
St Vincent's Hospital Melbourne HREC
Ethics committee address [1] 309215 0
41 Victoria Parade, Fitzroy, VIC, 3065
Ethics committee country [1] 309215 0
Australia
Date submitted for ethics approval [1] 309215 0
17/08/2021
Approval date [1] 309215 0
Ethics approval number [1] 309215 0

Summary
Brief summary
This is a multi-centre, open label, 2 cohort study to determine the ocular exposure levels of oral OCX063 in participants requiring retinal repair surgery. Following an OCX063 loading dose on the day of surgery, samples of aqueous and vitreous humour will be collected during the surgical procedure. Post-surgery, patients will take a once daily dose for the following 7 days. On Day 8, an aqueous humour sample will be collected via an aqueous tap.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113374 0
A/Prof Matthew Simunovic
Address 113374 0
Sydney Eye Hospital
8 Macquarie Street
Sydney NSW 2000
Country 113374 0
Australia
Phone 113374 0
+61 2 9382 7111
Fax 113374 0
Email 113374 0
[email protected]
Contact person for public queries
Name 113375 0
Ms Nicole Kruger
Address 113375 0
OccuRx Pty Ltd
Level 9, 31 Queen St
Melbourne VIC 3000
Country 113375 0
Australia
Phone 113375 0
+61 425 846 036
Fax 113375 0
Email 113375 0
[email protected]
Contact person for scientific queries
Name 113376 0
Ms Nicole Kruger
Address 113376 0
OccuRx Pty Ltd
Level 9, 31 Queen St
Melbourne VIC 3000
Country 113376 0
Australia
Phone 113376 0
+61 425 846 036
Fax 113376 0
Email 113376 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.