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

This study has been withdrawn prior to enrollment.
(No subjects enrolled)
Sponsor:
Collaborator:
Alcon Research
Information provided by:
Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov Identifier:
NCT00211354
First received: September 13, 2005
Last updated: February 3, 2009
Last verified: February 2009

September 13, 2005
February 3, 2009
March 2002
March 2007   (final data collection date for primary outcome measure)
to investigate the use of anecortave acetate for treatment of retinal vein occlusion [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Not Provided
Complete list of historical versions of study NCT00211354 on ClinicalTrials.gov Archive Site
mean change of VA (ETDRS) from baseline to 24 months [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Treatment of Retinal Vein Occlusion (RVO) With Open-Label Anecortave Acetate (15mg.)
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Retinal Vein Occlusion
Drug: Anecortave Acetate
ancortave acetate 15 mg. juxtascleral injection every 6 months for 24 months.
Other Name: retaane
Experimental: anecortave acetate
anecortave acetate 15 mg. juxtascleral injection every 6 months for 24 months
Intervention: Drug: Anecortave Acetate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
April 2007
March 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00211354
AA in RVO
No
Joan Daly,RN, LuEsther T. Mertz Retinal Research Center
Manhattan Eye, Ear & Throat Hospital
Alcon Research
Principal Investigator: Lawrence A. Yannuzzi, MD Manhattan Eye, Ear & Throat Hospital
Manhattan Eye, Ear & Throat Hospital
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP