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

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Anecortave Acetate Sterile Suspension, 30 mg/mL
Anecortave Acetate Sterile Suspension, 60 mg/mL
Anecortave Acetate Vehicle
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring exudative AMD, age-related macular degeneration (AMD)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alcon Study Sites

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Sham Comparator

Arm Label

15 mg Anecortave Acetate, 3 month intervals

15 mg Anecortave Acetate, 6 month intervals

30 mg Anecortave Acetate, 6 month intervals

Anecortave Acetate Vehicle

Arm Description

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).

Anecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months).

Anecortave Acetate Sterile Suspension, 60 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months).

One 0.5 mL sham injection of Anecortave Acetate Vehicle at 6 month intervals (3, 9, 15, 21 months).

Outcomes

Primary Outcome Measures

Mean change in best-corrected visual acuity (BCVA) at Month 12 from baseline

Secondary Outcome Measures

Mean change in lesion growth at Month 12 from baseline

Full Information

First Posted
March 3, 2006
Last Updated
November 27, 2012
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00299507
Brief Title
Anecortave Acetate in Patients With Exudative Age-related Macular Degeneration (AMD)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
exudative AMD, age-related macular degeneration (AMD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
15 mg Anecortave Acetate, 3 month intervals
Arm Type
Experimental
Arm Description
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).
Arm Title
15 mg Anecortave Acetate, 6 month intervals
Arm Type
Experimental
Arm Description
Anecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months).
Arm Title
30 mg Anecortave Acetate, 6 month intervals
Arm Type
Experimental
Arm Description
Anecortave Acetate Sterile Suspension, 60 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months).
Arm Title
Anecortave Acetate Vehicle
Arm Type
Sham Comparator
Arm Description
One 0.5 mL sham injection of Anecortave Acetate Vehicle at 6 month intervals (3, 9, 15, 21 months).
Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate Sterile Suspension, 30 mg/mL
Intervention Description
One 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals
Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate Sterile Suspension, 60 mg/mL
Intervention Description
One 0.5 mL posterior juxtascleral depot injection at 6 month intervals
Intervention Type
Other
Intervention Name(s)
Anecortave Acetate Vehicle
Intervention Description
One 0.5 mL sham injection at 6 month intervals
Primary Outcome Measure Information:
Title
Mean change in best-corrected visual acuity (BCVA) at Month 12 from baseline
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Mean change in lesion growth at Month 12 from baseline
Time Frame
Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alcon Investigators
Organizational Affiliation
Alcon Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patricia Zilliox, Ph.D.
Organizational Affiliation
Alcon Research
Official's Role
Study Director
Facility Information:
Facility Name
Alcon Study Sites
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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