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Treatment of Rubeosis Iridis With Open-Label Anecortave Acetate Sterile Suspension ( 15 mg.).

Primary Purpose

Severe Diabetic Retinopathy, Central Retinal Vein Occlusion, Chronic Inflammation

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
anecortave acetate
Sponsored by
Manhattan Eye, Ear & Throat Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Manhattan Eye, Ear & Throat Hospital

Outcomes

Primary Outcome Measures

tyo investigate the use of anecortave acetate in rubeosis iridis

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
May 4, 2007
Sponsor
Manhattan Eye, Ear & Throat Hospital
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00211471
Brief Title
Treatment of Rubeosis Iridis With Open-Label Anecortave Acetate Sterile Suspension ( 15 mg.).
Official Title
Treatment of Rubeosis Iridis With Open-Label Anecortave Acetate Sterile Suspension (15mg.).
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Terminated
Why Stopped
poor enrollment
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Manhattan Eye, Ear & Throat Hospital
Collaborators
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients will receive an injection of 15 mg of Anecortave acetate behind the eye to be treated ("study eye"). They will be evaluated every six months to determine if their condition is stable or worse. Following the injection of study medication, patients will not be required to come in to see the study physician. The investigator or study staff will call the patients on the day following injection to make sure there were no adverse effects to the injection. Patients will then come in for a Week 4 and Month 3 follow-up visit. At the Month 3 follow-up visit, if patients are not showing stability or improvement, they may be offered either thermal laser or Photodynamic Therapy. They will remain in the study and remain eligible for a repeat injection of Anecortave Acetate at the Month 6 visit. Patients will then been seen at Month 6 for a Re-treatment Evaluation Visit. If their condition is stable, they will be offered re-injection with the same study medication they received earlier. If Patients are not showing stability or improvement at the Month 6 visit, they may be offered thermal laser or Photodynamic Therapy in conjunction with the Anecortave Acetate injection. If the patient is re-injected at the 6 month visit, the schedule of follow-up visits will repeat as before for the next 18 months. If the patient opts out of the re-injection, they will be exited from the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Diabetic Retinopathy, Central Retinal Vein Occlusion, Chronic Inflammation, Infectious Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
anecortave acetate
Primary Outcome Measure Information:
Title
tyo investigate the use of anecortave acetate in rubeosis iridis
Time Frame
24 months
Secondary Outcome Measure Information:
Title
mean change in VA(ETDRS) from baseline to 24 months
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence A. Yannuzzi, MD
Organizational Affiliation
Manhattan Eye, Ear & Throat Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Eye, Ear & Throat Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Treatment of Rubeosis Iridis With Open-Label Anecortave Acetate Sterile Suspension ( 15 mg.).

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