Treatment of Pseudovitellium Detachment With Open-Label Anecortave Acetate Sterile Suspension (15 mg)
1 other identifier
interventional
4
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedOctober 25, 2012
October 1, 2012
2 years
September 13, 2005
October 24, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Title: Treatment of Pseudovitellium Detachment With Open-Label Anecortave Acetate Sterile Suspension (15mg)
24 months
Study Arms (1)
Title: Treatment of Pseudovitellium Detachment
EXPERIMENTALOpen-Label Anecortave Acetate Sterile Suspension(15mg)
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of patients with pseudovitellium detachment.
- Patients must be at least 18 years of age.
- Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart
- Visual acuity of 20/800 or better in 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 the 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 choroidal neovascularization (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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Manhattan Eye, Ear & Throat Hospitallead
- Alcon Researchcollaborator
Study Sites (1)
Manhattan Eye, Ear & Throat Hospital
New York, New York, 10021, United States
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Lawrence Yannuzzi, MD
Manhattan Eye, Ear & Throat Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lawrence A. Yannuzzi, M.D.
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
April 1, 2008
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
October 25, 2012
Record last verified: 2012-10