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

Phase 2

Withdrawn

• Conditions: Retinal Vein Occlusion
• Interventions: Drug: Anecortave Acetate

• Registration Number: NCT00211354
• Lead Sponsor: Manhattan Eye, Ear & Throat Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2007-03
• Study Completion: 2007-04
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-03
• Last Update Posted: 2009-02-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Clinical diagnosis of patients Retinal Vein Occlusion.
2. Patients must be 18 years of age or older to receive treatment.
3. Visual acuity of 20/30 to 20/320 Study Eye on the ETDRS visual acuity chart.
4. Visual acuity of 20/800 or better 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 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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anecortave acetate	Anecortave Acetate	anecortave acetate 15 mg. juxtascleral injection every 6 months for 24 months

Primary Outcome Measures

Name	Time	Method
to investigate the use of anecortave acetate for treatment of retinal vein occlusion	24 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Manhattan Eye, Ear & Throat Hospital; 🇺🇸 New York, New York, United States