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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
2% OC-10X
Placebo
Bangladesh Eye Hospital
Dhaka, Bangladesh
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the mean change of area of neovascularization of the disc (NVD) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the mean change of area of neovascularization of the disc (NVD) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the change of area of neovascularization elsewhere in the retina (NVE) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the change of area of neovascularization elsewhere in the retina (NVE) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the change of area of "Posterior NVE" from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by the change of area change of area of "Posterior NVE" from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by regression of total area of neovascularization (NVD+NVE) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
The effect of OC-10X 2% on regression/inhibition of neovascularization in PDR patients as measured by regression of total area of neovascularization (NVD+NVE) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Change from baseline of regression of intraretinal microvascular abnormalities (IRMA) in PDR patients as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Change from baseline of regression of intraretinal microvascular abnormalities (IRMA) in PDR patients as compared to Visit 6 (Week 24)for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Change from baseline of regression of intraretinal hemorrhage as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Change from baseline of regression of intraretinal hemorrhage as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Change from baseline of regression of venous beading as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Change from baseline of regression of venous beading as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Change from baseline of regression of area of capillary non-perfusion beading as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Change from baseline of regression of area of capillary non-perfusion beading as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Change from baseline of regression of intraretinal exudation (lipid) as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Change from baseline of regression of intraretinal exudation (lipid) as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Change from baseline of regression of macular edema (central subfield thickness) as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Change from baseline of regression of macular edema (central subfield thickness) as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Change from baseline of regression of macular volume as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
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Change from baseline of regression of macular volume as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Change from baseline of best-corrected ETDRS visual acuity as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Change from baseline of best-corrected ETDRS visual acuity as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Change from baseline of macular thickness as measured by Optical Coherence Tomography (OCT) compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Change from baseline of macular thickness as measured by Optical Coherence Tomography (OCT) compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo.
Time frame: Baseline - 24 weeks
Number of patients requiring rescue treatment at the end of the study.
Number of patients requiring rescue treatment at the end of the study.
Time frame: Baseline - 24 weeks
Number of patients requiring pars plana vitrectomy surgery due to presence of vitreous hemorrhage at the end of the study.
Number of patients requiring pars plana vitrectomy surgery due to presence of vitreous hemorrhage at the end of the study.
Time frame: Baseline - 24 weeks
Number of patients requiring pars plana vitrectomy surgery due to traction retinal detachment at the end of the study.
Number of patients requiring pars plana vitrectomy surgery due to traction retinal detachment at the end of the study.
Time frame: Baseline - 24 weeks