We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00299507
Recruitment Status : Completed
First Posted : March 7, 2006
Last Update Posted : November 28, 2012
Sponsor:
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL Other: Anecortave Acetate Vehicle Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2005
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Mean change in best-corrected visual acuity (BCVA) at Month 12 from baseline [ Time Frame: Month 12 ]

Secondary Outcome Measures :
  1. Mean change in lesion growth at Month 12 from baseline [ Time Frame: Month 12 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299507


Locations
United States, Texas
Alcon Study Sites
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Principal Investigator: Alcon Investigators Alcon Research
Study Director: Patricia Zilliox, Ph.D. Alcon Research
More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00299507     History of Changes
Other Study ID Numbers: C-04-59
First Posted: March 7, 2006    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: September 2009

Keywords provided by Alcon Research:
exudative AMD
age-related macular degeneration (AMD)

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Anecortave
Hydrocortisone
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents