Proliferative Diabetic Retinopathy (PDR) Clinical Trial
Official title:
A Phase II, Randomized, Placebo-Controlled, Study Assessing Efficacy and Safety of OC-10X Ophthalmic Suspension in the Treatment of Proliferative Diabetic Retinopathy
The present study is intended to evaluate the efficacy and safety of topical OC-10X
Ophthalmic Suspension in patients diagnosed with proliferative diabetic retinopathy (level
61, 65, 71, or 75). 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 both anti-angiogenic (inhibition) and
angiolytic (regression) properties in animal models of choroidal neovascularization (CNV).
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, may be a
promising new approach to the treatment of PDR and AMD. Like AMD, PDR is a major cause of
blindness in adults and is also caused by the growth of abnormal blood vessels. Importantly,
the Phase I Study found that OC-10X can be safely applied topically in human eyes without
adverse ocular or systemic effects.
Currently, there are few options for the treatment of PDR. Clinical options, such as laser
photocoagulation or vitrectomy, require surgery and can permanently impair patients' vision.
With few treatment options available, administration of OC-10X as a topical therapy, along
with its novel mechanism, has the potential to provide benefits to patients with ocular
diseases associated with angiogenesis.
n/a
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