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

Macular Degeneration Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00065728
• Other study ID #: C-03-15
• Status: Terminated
• Phase: Phase 3
• First received: July 31, 2003
• Last updated: September 4, 2013
• Start date: June 2003
• Est. completion date: October 2008

Study information

• Verified date: May 2009
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 111
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
United States	Belgium,France,Germany,Hungary,Italy,Netherlands,Poland,Spain,Sweden,UK	Central Contact Ft. Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients who maintained stable vision	Stable vision is defined as < 15-letter loss of best-corrected visual acuity scores)	Month 24	No
Primary	Mean change in best-corrected visual acuity at Month 24 from baseline		Baseline, Month 24	No