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Completed

NCT Number: NCT00299507

Anecortave Acetate 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).

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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alcon Study Sites

Fort Worth, Texas, 76134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anecortave Acetate Sterile Suspension, 30 mg/mL

Drug

One 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals

Anecortave Acetate Sterile Suspension, 60 mg/mL

Drug

One 0.5 mL posterior juxtascleral depot injection at 6 month intervals

Anecortave Acetate Vehicle

Other

One 0.5 mL sham injection at 6 month intervals

Primary outcomes

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

    Time frame: Month 12

Secondary outcomes

  1. Mean change in lesion growth at Month 12 from baseline

    Time frame: Month 12

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study 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)

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Mar 7, 2006
Registry last updated
Nov 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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