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Treatment of Pseudovitellium Detachment With Open-Label Anecortave Acetate Sterile Suspension (15 mg)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00211432
First Posted: September 21, 2005
Last Update Posted: October 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Joan, Manhattan Eye, Ear & Throat Hospital
  Purpose
The purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control pseudovitelliform detachment.

Condition Intervention Phase
Pseudovitellium Detachment Eye Diseases Drug: Anecortave Acetate Sterile Suspension (15 mg) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Joan, Manhattan Eye, Ear & Throat Hospital:

Primary Outcome Measures:
  • Title: Treatment of Pseudovitellium Detachment With Open-Label Anecortave Acetate Sterile Suspension (15mg) [ Time Frame: 24 months ]

Enrollment: 4
Study Start Date: April 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Title: Treatment of Pseudovitellium Detachment
Open-Label Anecortave Acetate Sterile Suspension(15mg)
Drug: Anecortave Acetate Sterile Suspension (15 mg)

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of patients with pseudovitellium detachment.
  2. Patients must be at least 18 years of age.
  3. Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart
  4. Visual acuity of 20/800 or better in 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 the 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 choroidal neovascularization (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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211432


Locations
United States, New York
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 Yannuzzi, MD Manhattan Eye, Ear & Throat Hospital
  More Information

Responsible Party: Joan, Lawrence A. Yannuzzi, M.D., Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov Identifier: NCT00211432     History of Changes
Other Study ID Numbers: Pseudovitellium Detachment
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: October 25, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Eye Diseases
Anecortave
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents