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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00299507
First received: March 3, 2006
Last updated: November 27, 2012
Last verified: September 2009
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean change in best-corrected visual acuity (BCVA) at Month 12 from baseline [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in lesion growth at Month 12 from baseline [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: March 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00299507     History of Changes
Other Study ID Numbers: C-04-59
Study First Received: March 3, 2006
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases
Anecortave
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014