Anecortave Acetate Versus Placebo in AMD Patients Following PDT

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT00346866
First received: June 28, 2006
Last updated: August 4, 2008
Last verified: August 2008
  Purpose

The purpose of this study was to evaluate the efficacy of anecortave acetate for depot suspension (30 mg and 15 mg) plus PDT versus PDT alone with respect to maintenance of visual acuity in patients with wet AMD.


Condition Intervention Phase
AMD
Drug: anecortave acetate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Anecortave Acetate Versus Placebo in AMD Patients Following PDT

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean change from the baseline in logMAR visual acuity score at Month 6

Secondary Outcome Measures:
  • % patients who maintained vision, number of months of angiographic evidence of needing PDT re-treatment, and mean lesion sizes for the total choroidal neovascularization (CNV) and the classic component to the total CNV.

Estimated Enrollment: 136
Study Start Date: May 2000
Study Completion Date: December 2001
Primary Completion Date: December 2001 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • AMD disease

Exclusion Criteria:

  • Age
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346866

Locations
United States, Ohio
Facility
Beachwood, Ohio, United States, 44122
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Patricia Zilliox Alcon Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00346866     History of Changes
Other Study ID Numbers: C-00-07
Study First Received: June 28, 2006
Last Updated: August 4, 2008
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014