Clincosm LogoSign in Get a demo

Treatment of Diabetic Retinopathy With Open-Label Anecortave Acetate Sterile Suspension (15 mg)

Sponsor
Manhattan Eye, Ear & Throat Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT00211406
Collaborator
Alcon Research (Industry)
1
Location

Study Details

Study Description

Brief Summary

The purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control diabetic retinopathy.

Condition or Disease Intervention/Treatment Phase
  • Drug: Anecortave Acetate Sterile Suspension (15 mg)
 Phase 1

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Clinical diagnosis of patients with diabetic retinopathy.

    2. Patients must be at least 18 years of age.

    3. Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart

    4. Visual acuity of 20/800 or better in fellow eye on the ETDRS visual acuity chart

    Exclusion Criteria:

    1. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.

    2. Patients who have undergone intraocular surgery within the last 2 months.

    3. Patient participating in any other investigational drug study.

    4. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.

    5. Inability to obtain photographs to document choroidal neovascularization (CNV) (including difficulty with venous access).

    6. Patient with significant liver disease or uremia.

    7. Patient with known adverse reaction to fluorescein and indocyanine green or iodine.

    8. Patient has a history of any medical condition which would preclude scheduled visits or completion of study

    9. Patient has had insertion of scleral buckle in the study eye

    10. Patient has received radiation treatment

    11. Patient is on anticoagulant therapy with the exception of aspirin

    12. Patient is pregnant or nursing.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Manhattan Eye, Ear & Throat Hospital New York New York United States 10021

    Sponsors and Collaborators

    • Manhattan Eye, Ear & Throat Hospital
    • Alcon Research

    Investigators

    • Principal Investigator: Lawrence Yannuzzi, MD, Manhattan Eye, Ear & Throat Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00211406
    Other Study ID Numbers:
    • Diabetic Retinopathy
    First Posted:
    Sep 21, 2005
    Last Update Posted:
    May 8, 2007
    Last Verified:
    May 1, 2007
    Additional relevant MeSH terms:
    Retinal Diseases
    Diabetic Retinopathy
    Anecortave

    Study Results

    No Results Posted as of May 8, 2007