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Sponsored by: |
Opko Health, Inc. |
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Information provided by: | Opko Health, Inc. |
ClinicalTrials.gov Identifier: | NCT00306904 |
The purpose of this study is to evaluate the pharmacokinetics, safety and preliminary efficacy of 3 doses of Cand5. Cand5 is a small interfering RNA molecule that selectively silences the mRNA encoding for VEGF. The target population are patients with diabetic macular edema.
Condition | Intervention | Phase |
---|---|---|
Diabetic Macular Edema |
Drug: bevasiranib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Pharmacokinetic, Randomized, Double-Masked, Controlled, Dose Comparison Study of Cand5 for Intravitreal Injection for the Treatment of Diabetic Macular Edema |
Enrollment: | 48 |
Study Start Date: | January 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | September 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
3.0 mg/eye dose group
|
Drug: bevasiranib |
2: Experimental
1.5 mg/eye dose group
|
Drug: bevasiranib |
3: Experimental
0.2 mg/eye dose group
|
Drug: bevasiranib |
Diabetic retinopathy is the leading cause of newly diagnosed blindness in the working age (20-74) population in the United States1 and diabetic macular edema (DME) is the leading cause of vision loss in diabetic retinopathy.
DME is the result of the breakdown of the retinal capillary endothelium in patients with diabetes mellitus (Type I and II).
A key factor in the development of DME is the permeability of the blood-retinal barrier. The breakdown of the endothelial tight junctions of the capillary walls in the retinal vasculature leads to increased permeation of salts, proteins, and water from the capillary luminal side of the barrier and the accumulation of fluid in the extracellular space. Multiple agents appear to contribute to the disruption of the blood-retina barrier,including vasoactive agents, prostaglandin and vascular endothelial growth factor (VEGF). VEGF is a peptide that promotes neovascularization and increases vascular permeability. If the resulting fluid is more than the amount that can be removed through the active pump mechanism (retinal pigmented epithelium), fluids continue to accumulate and edema develops. When thickening evolves or threatens the center of the fovea there is a high risk of visual loss.
Cand5 is a synthetic double stranded RNA (dsRNA) oligonucleotide. The molecule is a duplex formed by the hybridization of two partially complementary single strand RNAs in which the 3' end are capped with 2 deoxyribose (dT) units. Hybridization occurs across 19 ribose base pairs to yield the Cand5 molecule. Cand5 has a molecular weight of 13,345 grams/mole. Cand5 selectively silences the mRNA encoding for VEGF.
A comparison will be made between the three (3) treatment arms with regard to safety, efficacy, and duration of effect to determine a safe and efficacious dose of Cand5 appropriate for evaluation in future pivotal trials.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have the diagnosis of diabetes mellitus (type 1 or type 2). Patients with the following will be considered to be sufficient evidence that diabetes is present:
Exclusion Criteria:
A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control), including:
Responsible Party: | Opko Health ( Denis O'Shaughnessy ) |
Study ID Numbers: | ACU211 |
Study First Received: | March 23, 2006 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00306904 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Macular Edema Diabetic Retinopathy |
Signs and Symptoms Macular Edema Eye Diseases Retinal Degeneration |
Macular Degeneration Edema Retinal Diseases |
Signs and Symptoms Macular Edema Eye Diseases Retinal Degeneration |
Macular Degeneration Edema Retinal Diseases |