Safety and Efficacy Study of Small Interfering Ribonucleic Acid (RNA) Molecule (Cand5) to Treat Wet Age-Related Macular Degeneration

OPKO Health

Status and phase: Completed; Phase 2

Conditions: Macular Degeneration

Treatments: Drug: Bevasiranib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00259753

ACU201

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must have subfoveal classic, predominantly classic, or minimally classic lesions, secondary to AMD.
2. Patients must have ETDRS best corrected visual acuity of 64 to 24 letters (20/50 to 20/320 Snellen Equivalent) in the study eye.
3. Patients must be age 50 or older

Exclusion criteria

1. 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.
2. Patients with advanced glaucoma (greater than 0.8 cup:disk) or intraocular pressure above 22 mmHg in the study eye.
3. Patients with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye.
4. Patients with any subfoveal scarring, atrophy, or hemorrhage in the study eye.
5. Patients whose CNV lesion in the study eye contains more than 25% scarring and/or atrophy.
6. Patients who have undergone any extrafoveal/juxtafoveal laser treatment of the study eye within two weeks prior to the screening visit.
7. Patients who received treatment with an investigational drug within 4 weeks prior to the screening visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 3 patient groups

1

Experimental group

Description:

0.2 mg/eye

Treatment:

Drug: Bevasiranib

2

Experimental group

Description:

1.5 mg/eye

Treatment:

Drug: Bevasiranib

3

Experimental group

Description:

3.0 mg/eye

Treatment:

Drug: Bevasiranib