search
Back to results

Treatment of Retinal Vein Occlusion (RVO) With Open-Label Anecortave Acetate (15mg.)

Primary Purpose

Retinal Vein Occlusion

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anecortave Acetate
Sponsored by
Manhattan Eye, Ear & Throat Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion

Eligibility Criteria

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

Inclusion Criteria: Clinical diagnosis of patients Retinal Vein Occlusion. 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 on anticoagulant therapy with the exception of aspirin. Patient is pregnant or nursing.

Sites / Locations

  • Manhattan Eye, Ear & Throat Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

anecortave acetate

Arm Description

anecortave acetate 15 mg. juxtascleral injection every 6 months for 24 months

Outcomes

Primary Outcome Measures

to investigate the use of anecortave acetate for treatment of retinal vein occlusion

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
February 3, 2009
Sponsor
Manhattan Eye, Ear & Throat Hospital
Collaborators
Alcon Research
search

1. Study Identification

Unique Protocol Identification Number
NCT00211354
Brief Title
Treatment of Retinal Vein Occlusion (RVO) With Open-Label Anecortave Acetate (15mg.)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Withdrawn
Why Stopped
No subjects enrolled
Study Start Date
March 2002 (undefined)
Primary Completion Date
March 2007 (Anticipated)
Study Completion Date
April 2007 (Anticipated)

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
Retinal Vein Occlusion is a blockage of the blood vessels that drain out of the retina. Complications of retinal vein occlusion which threaten vision include neovascularization(growth of new blood vessels)and macular edema ( accumulation of fluid "leaking" from abnormal blood vessels). Currently, the treatment of retinal vein occlusion is laser photocoagulation. This treatment has found to have limited use in this type of condition.Anecortave Acetate is being considered as an attempt to control the growth of the abnormal blood vessels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Vein Occlusion

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

Arm Title
anecortave acetate
Arm Type
Experimental
Arm Description
anecortave acetate 15 mg. juxtascleral injection every 6 months for 24 months
Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate
Other Intervention Name(s)
retaane
Intervention Description
ancortave acetate 15 mg. juxtascleral injection every 6 months for 24 months.
Primary Outcome Measure Information:
Title
to investigate the use of anecortave acetate for treatment of retinal vein occlusion
Time Frame
24 months
Secondary Outcome Measure Information:
Title
mean change of 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 patients Retinal Vein Occlusion. 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 on anticoagulant therapy with the exception of aspirin. Patient is pregnant or nursing.
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 Retinal Vein Occlusion (RVO) With Open-Label Anecortave Acetate (15mg.)

We'll reach out to this number within 24 hrs