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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00259753

Enrollment

120

Registered

2005-12-01

Start date

2005-07-31

Completion date

2007-12-31

Last updated

2008-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration

Keywords

Wet Age-Related Macular Degeneration

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.

Interventions

DRUGBevasiranib

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography.	12 week

Secondary

Measure	Time frame
The secondary endpoint is the mean BCVA line/letters change from baseline at the 12-week evaluation.	12 week

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026