Proliferative Diabetic Retinopathy (PDR)
Conditions
Brief summary
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.
Interventions
DRUG2% OC-10X
2% OC-10X
DRUGPlacebo Comparator
Placebo
Sponsors
Semler Research Center Pvt. Ltd.
OcuCure Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male or female patients diagnosed with Proliferative Diabetic Retinopathy will be eligible if the following inclusion criteria are met: 1. Ability to provide approved written informed consent and complies with study-related procedures/assessments for the full duration of the study, having age ≥18 years. 2. Type 1 or Type 2 Diabetes Mellitus. 3. Proliferative Diabetic Retinopathy (level 61, 65, 71, or 75) in one or both eyes without evidence of significant vitreous/pre retinal hemorrhage that would limit photographic documentation of area of neovascularization and without pre-retinal fibrosis. If both eyes meet eligibility requirements, the less affected eye will be selected to receive investigational drug or placebo. The second eye will be treated with the standard of care. (e.g. panretinal laser photocoagulation). 4. Best-Corrected Visual acuity of 20/200 or better in each eye. 5. If female and: * Of childbearing potential, agrees to use an acceptable method of birth control as judged by the Investigator(s), such as condoms, foams, jellies, diaphragm, intrauterine device (IUD), for the duration of the study and for at least 2 weeks following the final dose of study drug or abstinence; or * Is postmenopausal for at least 1 year; or * Is surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). * Is not pregnant or breastfeeding.
Exclusion criteria
Male or female patients diagnosed with Proliferative Diabetic Retinopathy will not be eligible in the study if any of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Baseline - 24 weeks | 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. |
| 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. | 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 mean change of area of neovascularization of the disc (NVD) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo. | Baseline - 24 weeks | 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 regression of total area of neovascularization (NVD+NVE) from baseline compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 intraretinal exudation (lipid) as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo. | 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 macular edema (central subfield thickness) as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo. | 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 best-corrected ETDRS visual acuity as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo. | 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 macular thickness as measured by Optical Coherence Tomography (OCT) compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo. | 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. |
| Number of patients requiring rescue treatment at the end of the study. | Baseline - 24 weeks | Number of patients requiring rescue treatment 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. | 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 traction retinal detachment at the end of the study. | Baseline - 24 weeks | Number of patients requiring pars plana vitrectomy surgery due to traction retinal detachment at the end of the study. |
| Change from baseline of regression of macular volume as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo. | Baseline - 24 weeks | Change from baseline of regression of macular volume 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. | 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 hemorrhage as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo. | 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 venous beading as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo. | Baseline - 24 weeks | Change from baseline of regression of venous beading as compared to Visit 6 (Week 24) for OC-10X 2% vs. Placebo. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of how the eye feels as assessed by patient query. | Baseline - 24 weeks | Change from baseline of how the eye feels as assessed by patient query. |
| Evaluation of systemic exposure as measured by bioanalytic methods. | Baseline - 24 weeks | Evaluation of systemic exposure as measured by bioanalytic methods. |
| Change from baseline of evaluation of vital signs (body temperature, pulse rate blood pressure and respiratory rate). | Baseline - 24 weeks | Change from baseline of evaluation of vital signs (body temperature, pulse rate blood pressure and respiratory rate). |
| Change from baseline of evaluation of corneal epithelium, bulbar and lower conjunctiva by biomicroscopy. | Baseline - 24 weeks | Change from baseline of evaluation of corneal epithelium, bulbar and lower conjunctiva by biomicroscopy. |
Countries
Bangladesh
Outcome results
None listed