A phase II open label study to determine the ocular pharmacokinetics of oral OCX063.
- Conditions
- Retinal detachmentEye - Diseases / disorders of the eye
- Registration Number
- ACTRN12621001357842
- Lead Sponsor
- OccuRx Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 12
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.
- 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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method evels of OCX063 in vitreous humour (sample collected during surgery)[On Day 1 approximately 3 hours after loading dose];Levels of OCX063 in aqueous humour (D1 sample collected during surgery and D8 sample collected via aqueous tap)[On Day 1 approximately 3 hours after loading dose and on Day 8 approximately 3 hours after final dose]
- Secondary Outcome Measures
Name Time Method Safety as assessed by occurrence of adverse events as per ICH GCP and protocol definitions[Throughout study period];Safety assessed by biochemistry, haematology, and coagulation laboratory values[Day 8 compared to baseline]