Phase I Study Assessing the Ocular and Systemic Safety and Tolerability of OC-10X
- Registration Number
- NCT01869933
- Lead Sponsor
- OcuCure Therapeutics, Inc.
- Brief Summary
The present study is intended to evaluate the safety and tolerability of topical OC-10X Ophthalmic Suspension in healthy human subjects. OcuCure Therapeutics, Inc. (Roanoke, VA) has developed a lead compound, known as OC-10X, which is a selective tubulin inhibitor under development for the treatment of Proliferative Diabetic Retinopathy (PDR) and Age-related Macular Degeneration (AMD). When administered as a topical eye drop, OC-10X has demonstrated both anti-angiogenic (inhibition) and angiolytic (regression) properties in animal models of AMD. Unlike other therapies, OC-10X provides the efficacy of a vascular targeting agent without the traditional toxicity and works downstream independently of growth factors. As demonstrated by OcuCure's preclinical data, tubulin inhibition using OC-10X has promise as a new therapeutic approach. PDR is a major cause of blindness in adults and is also caused by the growth of abnormal blood vessels. These new blood vessels are fragile and may hemorrhage into the vitreous. PDR affects up to 80% of all diabetics who have had diabetes for 15 years or more. If administration of OC-10X is well tolerated as a topical eye drop and is well tolerated systemically, then OC-10X will have the potential to provide benefits to patients with ocular diseases associated with angiogenesis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1% OC-10X OC-10X Subjects selected to Cohort I will receive active 1% OC-10X in OD (Oculus Dexter - right eye) and placebo (vehicle) in OS (Oculus Sinister - left eye) in the Period 1 dosing. On Study Day 1 the subjects will have a drop instilled in each eye by personnel at study hours 0, 3, 6 and 9, and be evaluated frequently throughout the day. Subjects will be examined on Study Day 2 (24 hours after first dose). On Study Day 3 (48 hours after the first dose), these subjects will commence Period 2 dosing, with the active (OD) or placebo (OS). Dosing will continue q.i.d. for an additional 13 days. 2% OC-10X OC-10X Subjects selected to Cohort II will receive active 2% OC-10X in OD (Oculus Dexter - right eye) and placebo (vehicle) in OS (Oculus Sinister - left eye) in the Period 1 dosing. On Study Day 1 the subjects will have a drop instilled in each eye by personnel at study hours 0, 3, 6 and 9, and be evaluated frequently throughout the day. Subjects will be examined on Study Day 2 (24 hours after first dose). On Study Day 3 (48 hours after the first dose), these subjects will commence Period 2 dosing, with the active (OD) or placebo (OS). Dosing will continue q.i.d. for an additional 13 days.
- Primary Outcome Measures
Name Time Method Ocular Safety and Tolerability 17 Days Ocular safety and tolerability will be assessed by subject query, biomicroscopy of anterior segment, ophthalmoscopy, measuring intraocular pressure (IOP) and checking visual acuity by modified Early Treatment Diabetic Retinopathy Study (ETDRS).
- Secondary Outcome Measures
Name Time Method Systemic Safety and Tolerability 17 Days Systemic safety and tolerability will be examined by checking vital signs including heart rate, blood pressure, body temperature and respiratory rate, by electrocardiography (ECG) and performing a physical exam. Normal systemic function will be examined by routine blood draw for clinical chemistry, complete blood chemistry (CBC) and measure of plasma concentration of OC-10X.
Trial Locations
- Locations (1)
Bangladesh Eye Hospital
🇧🇩Dhaka, Bangladesh