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A Single-Center Pilot Study to Assess Macular Function

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ClinicalTrials.gov Identifier: NCT01204541
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : February 14, 2012
Sponsor:
Information provided by (Responsible Party):
ORA, Inc.

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

Condition or disease
Macular Degeneration

Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : September 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
AMD
Young normals
Older normals




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204541


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

Responsible Party: ORA, Inc.
ClinicalTrials.gov Identifier: NCT01204541     History of Changes
Other Study ID Numbers: 10-120-0013
First Posted: September 17, 2010    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012

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

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