NCT00211406

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.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

May 8, 2007

Status Verified

May 1, 2007

First QC Date

September 13, 2005

Last Update Submit

May 6, 2007

Conditions

Diabetic Retinopathy

Interventions

Anecortave Acetate Sterile Suspension (15 mg)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of patients with diabetic retinopathy.
  • Patients must be at least 18 years of age.
  • Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart
  • Visual acuity of 20/800 or better in fellow eye on the ETDRS visual acuity chart

You may not qualify if:

  • Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
  • Patients who have undergone intraocular surgery within the last 2 months.
  • Patient participating in any other investigational drug study.
  • Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
  • Inability to obtain photographs to document choroidal neovascularization (CNV) (including difficulty with venous access).
  • Patient with significant liver disease or uremia.
  • Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
  • Patient has a history of any medical condition which would preclude scheduled visits or completion of study
  • Patient has had insertion of scleral buckle in the study eye
  • Patient has received radiation treatment
  • Patient is on anticoagulant therapy with the exception of aspirin
  • Patient is pregnant or nursing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manhattan Eye, Ear & Throat Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Lawrence Yannuzzi, MD

    Manhattan Eye, Ear & Throat Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Last Updated

May 8, 2007

Record last verified: 2007-05

Locations

US(1)