Anecortave Acetate in Patients With Exudative Age-related Macular Degeneration (AMD)

November 27, 2012 updated by: Alcon Research

Anecortave Acetate 15 mg Administered Every 3 Months Versus Anecortave Acetate 15 mg Administered Every 6 Months Versus Anecortave Acetate 30 mg Administered Every 6 Months in Patients With Exudative Age-Related Macular Degeneration (AMD)

The purpose of this study was to evaluate the effect of the dose concentration and administration frequency of Anecortave Acetate (AA) on visual acuity (VA) and lesion size when administered by posterior juxtascleral depot (PJD) every 3 months (AA 15 mg) or 6 months (AA 15 mg, AA 30 mg) in patients with exudative age-related macular degeneration (AMD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Alcon Study Sites

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of exudative AMD and a primary or recurrent (after laser photocoagulation) subfoveal choroidal neovascularization (CNV) lesion.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Less than 50 years of age.
  • Other protocol-defined exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 15 mg Anecortave Acetate, 3 month intervals
Anecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 3 month intervals (0, 3, 6, 9, 12, 15, 18 months).
Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL
One 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals
Experimental: 15 mg Anecortave Acetate, 6 month intervals
Anecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months).
Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL
One 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals
Experimental: 30 mg Anecortave Acetate, 6 month intervals
Anecortave Acetate Sterile Suspension, 60 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months).
Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL
One 0.5 mL posterior juxtascleral depot injection at 6 month intervals
Sham Comparator: Anecortave Acetate Vehicle
One 0.5 mL sham injection of Anecortave Acetate Vehicle at 6 month intervals (3, 9, 15, 21 months).
Other: Anecortave Acetate Vehicle
One 0.5 mL sham injection at 6 month intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change in best-corrected visual acuity (BCVA) at Month 12 from baseline
Time Frame: Month 12
Month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change in lesion growth at Month 12 from baseline
Time Frame: Month 12
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Patricia Zilliox, Ph.D., Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

March 3, 2006

First Submitted That Met QC Criteria

March 3, 2006

First Posted (Estimate)

March 7, 2006

Study Record Updates

Last Update Posted (Estimate)

November 28, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-04-59

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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