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
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.

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 July 22, 2014