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

Retinal Vein Occlusion Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00211354
• Other study ID #: AA in RVO
• Status: Withdrawn
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: February 3, 2009
• Start date: March 2002
• Est. completion date: April 2007

Study information

• Verified date: February 2009
• Source: Manhattan Eye, Ear & Throat Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinal Vein Occlusion

Intervention

Drug:
• Anecortave Acetate
ancortave acetate 15 mg. juxtascleral injection every 6 months for 24 months.

Locations

Country	Name	City	State
United States	Manhattan Eye, Ear & Throat Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Manhattan Eye, Ear & Throat Hospital	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to investigate the use of anecortave acetate for treatment of retinal vein occlusion		24 months	Yes
Secondary	mean change of VA (ETDRS) from baseline to 24 months		24 months	Yes