NCT00259753CompletedPhase 2
A Phase II, Randomized, Double-Masked, Controlled, Dose Comparison Study of Cand5 for Intravitreal Injection for the Treatment of Subfoveal Choroidal Neovascularization Associated With Wet Age-Related Macular Degeneration
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- OPKO Health, Inc.
- Enrollment
- 120
- Locations
- 23
- Primary Endpoint
- change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography.
Study Overview
Brief Summary
The objective of this study is to evaluate the safety and preliminary efficacy of three doses of Cand5. Cand5, a small interfering RNA molecule that selectively silences the mRNA encoding for VEGF.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must have subfoveal classic, predominantly classic, or minimally classic lesions, secondary to AMD.
- •Patients must have ETDRS best corrected visual acuity of 64 to 24 letters (20/50 to 20/320 Snellen Equivalent) in the study eye.
- •Patients must be age 50 or older
Exclusion Criteria
- •Patients who have received prior treatment with any investigational new drug or device for wet AMD in the study eye within 24 weeks of the screening visit.
- •Patients with advanced glaucoma (greater than 0.8 cup:disk) or intraocular pressure above 22 mmHg in the study eye.
- •Patients with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye.
- •Patients with any subfoveal scarring, atrophy, or hemorrhage in the study eye.
- •Patients whose CNV lesion in the study eye contains more than 25% scarring and/or atrophy.
- •Patients who have undergone any extrafoveal/juxtafoveal laser treatment of the study eye within two weeks prior to the screening visit.
- •Patients who received treatment with an investigational drug within 4 weeks prior to the screening visit.
Arms & Interventions
1
Experimental
0.2 mg/eye
Intervention: Bevasiranib (Drug)
2
Experimental
1.5 mg/eye
Intervention: Bevasiranib (Drug)
3
Experimental
3.0 mg/eye
Intervention: Bevasiranib (Drug)
Outcomes
Primary Outcomes
change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography.
Time Frame: 12 week
Secondary Outcomes
- The secondary endpoint is the mean BCVA line/letters change from baseline at the 12-week evaluation.(12 week)
Investigators
Study Sites (23)
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