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

• Sponsor: Manhattan Eye, Ear & Throat Hospital (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00211354
• Collaborator: Alcon Research (Industry)
• Enrollment: 0
• Location: 1
• Arm: 1
• Duration (Months): 61
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Retinal Vein Occlusion	Drug: Anecortave Acetate	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Mar 1, 2002
• Anticipated Primary Completion Date: Mar 1, 2007
• Anticipated Study Completion Date: Apr 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: anecortave acetate anecortave acetate 15 mg. juxtascleral injection every 6 months for 24 months	Drug: Anecortave Acetate; ancortave acetate 15 mg. juxtascleral injection every 6 months for 24 months.; Other Names: retaane

Outcome Measures

Primary Outcome Measures

1. to investigate the use of anecortave acetate for treatment of retinal vein occlusion [24 months]

Secondary Outcome Measures

1. mean change of VA (ETDRS) from baseline to 24 months [24 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Manhattan Eye, Ear & Throat Hospital	New York	New York	United States	10021

Sponsors and Collaborators

• Manhattan Eye, Ear & Throat Hospital
• Alcon Research

Investigators

• Principal Investigator: Lawrence A. Yannuzzi, MD, Manhattan Eye, Ear & Throat Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00211354
• Other Study ID Numbers: AA in RVO
• First Posted: Sep 21, 2005
• Last Update Posted: Feb 4, 2009
• Last Verified: Feb 1, 2009

• Additional relevant MeSH terms: Retinal Vein Occlusion; Anecortave

Study Results

No Results Posted as of Feb 4, 2009