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

NCT00211354 | Withdrawn Phase 2

• 1 other identifier: AA in RVO
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

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

  24 months

Secondary Outcomes (1)

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

  24 months

Study Arms (1)

anecortave acetate

EXPERIMENTAL

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

Drug: Anecortave Acetate

Interventions

Anecortave Acetate DRUG

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

Also known as: retaane

anecortave acetate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manhattan Eye, Ear & Throat Hospital: lead
• Alcon Research: collaborator

Study Sites (1)

Manhattan Eye, Ear & Throat Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

anecortave acetate

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lawrence A. Yannuzzi, MD

  Manhattan Eye, Ear & Throat Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: March 1, 2002
• Primary Completion: March 1, 2007
• Study Completion: April 1, 2007
• Last Updated: February 4, 2009

Record last verified: 2009-02

Locations

US (1)