TerminatedInterventionalPhase 2Updated May 7, 2007
Treatment of Pseudovitellium Detachment With Open-Label Anecortave Acetate Sterile Suspension (15 mg) | NCT00211432 | Trialant
CompletedInterventionalPhase 2Updated Oct 25, 2012
Treatment of Pseudovitellium Detachment With Open-Label Anecortave Acetate Sterile Suspension (15 mg)
ClinicalTrials.gov ID
NCT00211432
Lead Sponsor
Manhattan Eye, Ear & Throat HospitalOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
4Actual
Last Update Posted
Oct 25, 2012Estimated
Start Date
Apr 2008
Primary Completion Date
Apr 2010Actual
Completion Date
Apr 2010Actual
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.
Pseudovitellium Detachment
Eye Diseases
Anecortave Acetate Sterile Suspension (15 mg)
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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