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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

July 31, 2003
September 4, 2013
June 2003
October 2008   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00065728 on ClinicalTrials.gov Archive Site
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Open-Label Posterior Juxtascleral Injections of Anecortave Acetate 15mg Dose for Long Term Use in Patients With AMD
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Macular Degeneration
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
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
Intervention: Drug: Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
111
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00065728
C-03-15
Not Provided
Alcon Research
Alcon Research
Not Provided
Study Director: Terry Wiernas, PhD Alcon Research
Alcon Research
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP