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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00333216
Other study ID # C-04-30
Secondary ID
Status Terminated
Phase Phase 3
First received May 31, 2006
Last updated November 27, 2012
Start date May 2005
Est. completion date December 2008

Study information

Verified date December 2011
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationSingapore: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study was to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of non-exudative (dry) age-related macular degeneration in patients who are at risk for progressing to exudative (wet) age-related macular degeneration.


Recruitment information / eligibility

Status Terminated
Enrollment 24
Est. completion date December 2008
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility Inclusion Criteria:

- Dry AMD in study eye, Wet AMD in non-study eye;

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Under 50;

- Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
Anecortave Acetate Sterile Suspension, 30 mg/mL
Posterior juxtascleral administration of suspension
Anecortave Acetate Sterile Suspension, 60 mg/ML
Posterior juxtascleral administration of suspension
Other:
Anecortave Acetate Vehicle
Sham posterior juxtascleral administration of suspension

Locations

Country Name City State
United States Contact Alcon Call Center for Trial Locations Fort 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 Proportion of patients with sight-threatening CNV in study eye Month 48 No
Secondary Time to development of sight-threatening CNV Up to 48 months No
Secondary Proportion of patients with stable vision Up to 48 months No
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