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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:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00346957
First received: June 28, 2006
Last updated: March 3, 2012
Last verified: March 2012
  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 Blind (Subject, 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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 50 years and over
  • Other protocol-defined inclusion and exclusion criteria may apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00346957     History of Changes
Other Study ID Numbers: C-98-03
Study First Received: June 28, 2006
Last Updated: March 3, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases
Anecortave
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014