A Single-Center Pilot Study to Assess Macular Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ORA, Inc.
ClinicalTrials.gov Identifier:
NCT01204541
First received: September 16, 2010
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

This study seeks to evaluate a novel endpoint for future dry AMD clinical trials.


Condition
Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by ORA, Inc.:

Enrollment: 24
Study Start Date: September 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
AMD
Young normals
Older normals

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Three groups of subjects will be enrolled:

  1. Normal healthy subjects aged 20-29 years
  2. Normal healthy subjects aged 60-90 years
  3. Subjects with early dry AMD
Criteria

Inclusion Criteria:

  • Subjects in good health aged 20-29 or 60-90 years (normal cohorts)
  • Subjects with early non-exudative age-related macular degeneration (AMD cohort)

Exclusion Criteria:

  • Enrollment in a investigational drug or device study and have used an investigational drug or device within 7 days of enrollment into this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01204541

Locations
United States, Massachusetts
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
ORA, Inc.
  More Information

No publications provided

Responsible Party: ORA, Inc.
ClinicalTrials.gov Identifier: NCT01204541     History of Changes
Other Study ID Numbers: 10-120-0013
Study First Received: September 16, 2010
Last Updated: February 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by ORA, Inc.:
Non-exudative age-related macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 23, 2014