NCT00211471

Brief Summary

To provide use of Anecortave Acetate Sterile Suspension of 15mg for a series of five patients with rubeosis iridis. Rubeosis iridis refers to neovascularization of the iris. It is caused by a number of conditions which include, but are not limited to severe diabetic retinopathy, central retinal vein occlusion, chronic inflammation, and infection. Anecortave acetate is an angiostatic, experimental drug that is being tested to prevent the growth of blood vessels under the retina in patients with age-related macular degeneration (AMD). Therefore, it is logical to apply the usage of Anecortave to patient's with rubeosis iridis in order to reduce the neovascularization stimulus and cause the regression of the abnormal iris vessels.

Trial Health

57
Monitor

Trial Health Score

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

Timeline
Completed

Started Mar 2002

Longer than P75 for phase_2

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

Study Start

First participant enrolled

March 1, 2002

Completed
3.5 years until next milestone

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
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

May 7, 2007

Status Verified

May 1, 2007

First QC Date

September 13, 2005

Last Update Submit

May 4, 2007

Conditions

Severe Diabetic RetinopathyCentral Retinal Vein OcclusionChronic InflammationInfectious Diseases

Outcome Measures

Primary Outcomes (1)

  • tyo investigate the use of anecortave acetate in rubeosis iridis

    24 months

Secondary Outcomes (1)

  • mean change in VA(ETDRS) from baseline to 24 months

    24 months

Interventions

anecortave acetateDRUG

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of rubeosis iridis in patients with retinal ischemia.
  • Patients must be 18 years of age or older to receive treatment.
  • Visual acuity of 20/30 to 20/320 Study Eye on the ETDRS visual acuity chart.
  • Visual acuity of 20/800 or better 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 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 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 pregnant or nursing.
  • Patient is on intravenous or subcutaneous anticoagulant therapy, or is on oral anticoagulant therapy (with the exception of aspirin and antiplatelet therapy) and cannot take a 5-day interruption in therapy prior to each depot or sham administration.
  • Patient has evidence of scleral thinning seen at the time of external eye exam or at the time of depot or sham administration.

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 RetinopathyRetinal Vein OcclusionCommunicable Diseases

Interventions

anecortave acetate

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lawrence A. Yannuzzi, MD

    Manhattan Eye, Ear & Throat Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Expanded Access
Yes

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

March 1, 2002

Study Completion

May 1, 2007

Last Updated

May 7, 2007

Record last verified: 2007-05

Locations

US(1)