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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00346957
First Posted: July 4, 2006
Last Update Posted: March 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alcon Research
  Purpose
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 Intervention Phase
AMD Drug: Anecortave acetate 30 mg Drug: Anecortave Acetate 15 mg Drug: Anecortave Acetate 3 mg Other: Anecortave Acetate Vehicle Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean change in logMAR visual acuity at 12 months from baseline. [ Time Frame: 12 months ]

Enrollment: 128
Study Start Date: April 1999
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 50 years and over
  • Other protocol-defined inclusion and exclusion criteria may apply.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00346957     History of Changes
Other Study ID Numbers: C-98-03
First Submitted: June 28, 2006
First Posted: July 4, 2006
Last Update Posted: March 6, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Anecortave
Hydrocortisone
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Anti-Inflammatory Agents