None listed
Conditions
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.
Interventions
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.
Sponsors
OccuRx Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed