Treatment of Retinal Vein Occlusion (RVO) With Open-Label Anecortave Acetate (15mg.)
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- to investigate the use of anecortave acetate for treatment of retinal vein occlusion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
anecortave acetate
anecortave acetate 15 mg. juxtascleral injection every 6 months for 24 months
Intervention: Anecortave Acetate (Drug)
Outcomes
Primary Outcomes
to investigate the use of anecortave acetate for treatment of retinal vein occlusion
Time Frame: 24 months
Secondary Outcomes
- mean change of VA (ETDRS) from baseline to 24 months(24 months)