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

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.

Study Overview

• Status: Completed
• Conditions: Eye Diseases; Pseudovitellium Detachment
• Intervention / Treatment: Drug: Anecortave Acetate Sterile Suspension (15 mg)

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Manhattan Eye, Ear & Throat Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Title: Treatment of Pseudovitellium Detachment; Open-Label Anecortave Acetate Sterile Suspension(15mg)	Drug: Anecortave Acetate Sterile Suspension (15 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Title: Treatment of Pseudovitellium Detachment With Open-Label Anecortave Acetate Sterile Suspension (15mg)	24 months

Collaborators and Investigators

• Sponsor: Manhattan Eye, Ear & Throat Hospital
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Lawrence Yannuzzi, MD, Manhattan Eye, Ear & Throat Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): October 25, 2012
• Last Update Submitted That Met QC Criteria: October 24, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Anecortave
• Other Study ID Numbers: Pseudovitellium Detachment