A Phase II Study of Anecortave Acetate for the Treatment of Exudative Age-Related Macular Degeneration

AMD Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00346957
• Other study ID #: C-98-03
• Status: Completed
• Phase: Phase 2
• First received: June 28, 2006
• Last updated: March 3, 2012
• Start date: April 1999
• Est. completion date: April 2003

Study information

• Verified date: March 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine the concentration of anecortave acetate (15 or 30 mg versus placebo) that is safe and effective for the inhibition of the growth of blood vessels in the retina in patients with wet AMD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: April 2003
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Ages 50 years and over

• Other protocol-defined inclusion and exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• AMD
• Macular Degeneration

Intervention

Drug:
• Anecortave acetate 30 mg
0.5ml administered onto the sclera once every six months for 24 months
• Anecortave Acetate 15 mg
0.5ml administered onto the sclera once every six months for 24 months
• Anecortave Acetate 3 mg
0.5ml administered onto the sclera once every six months for 24 months

Other:
• Anecortave Acetate Vehicle
0.5ml administered onto the sclera once every six months for 24 months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in logMAR visual acuity at 12 months from baseline.		12 months