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

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00346957
• Collaborator: (none)
• Enrollment: 128
• Arms: 4
• Duration (Months): 48

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
AMD	Drug: Anecortave acetate 30 mg; Drug: Anecortave Acetate 15 mg; Drug: Anecortave Acetate 3 mg; Other: Anecortave Acetate Vehicle	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 1999
• Actual Primary Completion Date: Apr 1, 2003
• Actual Study Completion Date: Apr 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anecortave Acetate 30	Drug: Anecortave acetate 30 mg; 0.5ml administered onto the sclera once every six months for 24 months
Experimental: Anecortave Acetate 15	Drug: Anecortave Acetate 15 mg; 0.5ml administered onto the sclera once every six months for 24 months
Experimental: Anecortave Acetate 3	Drug: Anecortave Acetate 3 mg; 0.5ml administered onto the sclera once every six months for 24 months
Placebo Comparator: Anecortave Acetate Vehicle	Other: Anecortave Acetate Vehicle; 0.5ml administered onto the sclera once every six months for 24 months

Outcome Measures

Primary Outcome Measures

1. Mean change in logMAR visual acuity at 12 months from baseline. [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ages 50 years and over

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00346957
• Other Study ID Numbers: C-98-03
• First Posted: Jul 4, 2006
• Last Update Posted: Mar 6, 2012
• Last Verified: Mar 1, 2012

• Additional relevant MeSH terms: Hydrocortisone; Anecortave

Study Results

No Results Posted as of Mar 6, 2012