Open-Label Posterior Juxtascleral Injections of Anecortave Acetate 15mg Dose for Long Term Use in Patients With AMD

This study has been terminated.
(Management decision)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00065728
First received: July 31, 2003
Last updated: September 4, 2013
Last verified: May 2009
  Purpose

The purpose of this study is to investigate the long-term efficacy and safety of posterior juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months.


Condition Intervention Phase
Macular Degeneration
Drug: Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Evaluation of Long Term Efficacy and Safety of Posterior Juxtascleral Injections of Anecortave Acetate 15 mg in Patients With Subfoveal Exudative Age-Related Macular Degeneration (AMD)

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Percent of patients who maintained stable vision [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    Stable vision is defined as < 15-letter loss of best-corrected visual acuity scores)

  • Mean change in best-corrected visual acuity at Month 24 from baseline [ Time Frame: Baseline, Month 24 ] [ Designated as safety issue: No ]

Enrollment: 111
Study Start Date: June 2003
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anecortave Acetate, 15 mg
One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months
Drug: Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL
One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months

  Eligibility

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

Inclusion Criteria:

  • Patients with subfoveal exudative age-related macular degeneration (AMD) who were previously enrolled in long-term studies with anecortave acetate.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065728

Locations
United States, Texas
Belgium,France,Germany,Hungary,Italy,Netherlands,Poland,Spain,Sweden,UK
Central Contact Ft. Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Terry Wiernas, PhD Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00065728     History of Changes
Other Study ID Numbers: C-03-15
Study First Received: July 31, 2003
Last Updated: September 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
AMD
age-related macular degeneration
Anecortave
Acetate
Wet form of age-related macular degeneration
CNV
Anecortave Acetate

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 20, 2014