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CompletedNCT00299507Updated Nov 28, 2012

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

A Phase 3 interventional study of Anecortave Acetate Sterile Suspension, 30 mg/mL and Anecortave Acetate Sterile Suspension, 60 mg/mL in Macular Degeneration, sponsored by Alcon Research. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2012-11-28.

Sponsored by Alcon Research · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Macular Degeneration

Keywords

  • exudative AMD
  • age-related macular degeneration (AMD)
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 240 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Less than 50 years of age.
  • Other protocol-defined exclusion criteria may apply.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
240 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • DrugAnecortave Acetate Sterile Suspension, 30 mg/mL

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

  • DrugAnecortave Acetate Sterile Suspension, 60 mg/mL

    One 0.5 mL posterior juxtascleral depot injection at 6 month intervals

  • OtherAnecortave Acetate Vehicle

    One 0.5 mL sham injection at 6 month intervals

06

What researchers measure

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

07

Study locations

1 site
  • Alcon Study Sites
    Fort Worth, Texas 76134, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00299507
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Mar 7, 2006
Start date
Mar 2005
Primary completion
Apr 2008
Completion
Apr 2008
Last update
Nov 28, 2012

Study contacts

Alcon Investigators
principal investigator · Alcon Research
Patricia Zilliox, Ph.D.
study director · Alcon Research

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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