NCT01869933

Phase I Study Assessing the Ocular and Systemic Safety and Tolerability of OC-10X

An Open Label Phase I Placebo Controlled, Dose Escalation Study Assessing the Ocular and Systemic Safety and Tolerability of OC-10X

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: OcuCure Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Proliferative Diabetic Retinopathy (PDR)

Interventions

Type	Name	Description
DRUG	OC-10X

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-06-05
• Last updated: 2016-01-22

Locations

1 site across 1 country: Bangladesh