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OpenTrials
Completed

NCT Number: NCT00211432

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Manhattan Eye, Ear & Throat Hospital

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Patient is pregnant or nursing.

Treatment and study plan

Anecortave Acetate Sterile Suspension (15 mg)

Drug

Primary outcomes

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

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Manhattan Eye, Ear & Throat Hospital

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 21, 2005
Registry last updated
Oct 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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