Safety and Efficacy Study of Small Interfering RNA Molecule (Cand5) to Treat Diabetic Macular Edema

NCT00306904 | Completed Phase 2 DMC

• 1 other identifier: ACU211
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Macular Edema

Keywords

Macular; Edema; Diabetic; Retinopathy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• Mean BCVA line/letters change from baseline at the 12-week evaluation.

Study Arms (3)

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

Interventions

bevasiranib DRUG

Also known as: Cand5

1; 2; 3

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be male or female age 21 or older.
• Patient must sign (and be given) a copy of the written informed consent form.
• 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:
• Current regular use of insulin for the treatment of diabetes mellitus OR
• Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes OR
• Documented diabetes by WHO criteria
• Patients must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen Equivalent) in the study eye.
• Patients must have a mean retinal thickness on OCT ≥ 250 microns in the central subfield.

You may not qualify if:

• Patients with a history of chronic renal failure requiring dialysis or kidney transplant.
• 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:
• Patients in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.
• Patients with HbA1C \> 10%OR
• Patients with systolic blood pressure greater than 170 mmHg and/or diastolic blood pressure greater than 100 mmHg (Note: If blood pressure is brought below 170/100 mmHg by anti-hypertensive treatment, patient can become eligible).
• Past panretinal photocoagulation (PRP) for diabetes within 12 weeks of screening or PRP expected to be needed in the next three months in the study eye.
• Focal laser therapy to the retina of the study eye within 12 weeks of screening.
• Any intraocular surgery or ocular laser procedures in the study eye within 12 weeks of screening.
• Participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at the time of study entry.

Sponsors & Collaborators

• OPKO Health, Inc.: lead

Study Sites (1)

Retina Associates of Cleveland

Beechwood, Ohio, 44122, United States

Location

Related Links

• Sponsor

MeSH Terms

Conditions

Edema; Retinal Diseases

Interventions

bevasiranib

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Eye Diseases

Study Officials

• Christine Du Castel, MD

  Chiltern International

  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: March 23, 2006
• First Posted: March 27, 2006
• Study Start: January 1, 2006
• Primary Completion: September 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 25, 2008

Record last verified: 2008-07

Locations

US (1)