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

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ClinicalTrials.gov Identifier: NCT00065728
Recruitment Status : Terminated (Management decision)
First Posted : August 1, 2003
Last Update Posted : September 16, 2013
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 or disease Intervention/treatment Phase
Macular Degeneration Drug: Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : June 2003
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Percent of patients who maintained stable vision [ Time Frame: Month 24 ]
    Stable vision is defined as < 15-letter loss of best-corrected visual acuity scores)

  2. Mean change in best-corrected visual acuity at Month 24 from baseline [ Time Frame: Baseline, Month 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00065728     History of Changes
Other Study ID Numbers: C-03-15
First Posted: August 1, 2003    Key Record Dates
Last Update Posted: September 16, 2013
Last Verified: May 2009

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
Anecortave
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents