NCT00259753

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

August 5, 2008

Status Verified

July 1, 2008

Enrollment Period

2.4 years

First QC Date

November 30, 2005

Last Update Submit

August 4, 2008

Conditions

Macular Degeneration

Keywords

Wet Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

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

    12 week

Secondary Outcomes (1)

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

    12 week

Study Arms (3)

1

EXPERIMENTAL

0.2 mg/eye

Drug: Bevasiranib

2

EXPERIMENTAL

1.5 mg/eye

Drug: Bevasiranib

3

EXPERIMENTAL

3.0 mg/eye

Drug: Bevasiranib

Interventions

BevasiranibDRUG
Also known as: Cand5
123

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Acuity Participating Site

Phoenix, Arizona, 85014, United States

Location

Retina Centers PC

Tucson, Arizona, 85704, United States

Location

Sall Research Medical Center

Artesia, California, 90701, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

Florida Eye Microsurgical Institute, Inc.

Boynton Beach, Florida, 33426, United States

Location

Retina Specialist

Towson, Maryland, 21204, United States

Location

Vitreo-Retinal Associates PC

Grand Rapids, Michigan, 49525, United States

Location

Associated Retinal Consultants

Grand Rapids, Michigan, 49546, United States

Location

Associated Retinal Consultants, P.C.

Royal Oak, Michigan, 48073, United States

Location

VitreoRetinal Surgery, P.A.

Edina, Minnesota, 55435, United States

Location

Eye Foundation of Kansas City, UMKC School of Medicine

Kansas City, Missouri, 64108, United States

Location

Retina-Vitreous Center

Lakewood, New Jersey, 08701, United States

Location

Retina-Vitreous Consultants

Livingston, New Jersey, 07039, United States

Location

OCLI

Lynbrook, New York, 11563, United States

Location

LuEsther T. Mertz Retinal Research Center

New York, New York, 10021, United States

Location

Southeast Clinical Research

Charlotte, North Carolina, 28210, United States

Location

Retina Associates of Cleveland

Beachwood, Ohio, 44122, United States

Location

Retina Associates of Cleveland, Inc.

Lakewood, Ohio, 44107, United States

Location

Black Hills Eye Institute

Rapid City, South Dakota, 57701, United States

Location

Retina Reseach Center

Austin, Texas, 78705, United States

Location

Ophthalmology Associates

Fort Worth, Texas, 76102, United States

Location

Vitreoretinal Consultants Houston TX

Houston, Texas, 77030, United States

Location

Medical College of Wisconsin Eye Institute

Milwaukee, Wisconsin, 53226, United States

Location

Related Links

MeSH Terms

Conditions

Macular Degeneration

Interventions

bevasiranib

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Denis O'Shaughnessy, PHD

    Opko Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 1, 2005

Study Start

July 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

August 5, 2008

Record last verified: 2008-07

Locations

US(23)