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A Natural History of the Progression of Stargardt Disease: Retrospective and Prospective Studies

NCT01977846 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 259

Last updated 2019-11-01

Study results available
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Summary

Stargardt disease is currently an incurable and untreatable macular dystrophy that causes severe visual loss in children and young adults, thereby causing enormous morbidity with economic, psychological, emotional, and social implications. There are no FDA approved therapeutic treatments for this disease. Therefore, the objective of this study is to collect natural history data from a large population of children and adults in order to evaluate possible efficacy measures for planned clinical trials.

Participants will be recruited from each Investigator's own patient population as the study requires the availability of both multiyear retrospective data, as well as ongoing prospectively collected data. A concurrent ancillary study (SMART study) is also being conducted with a subset of the prospective study patients during their regular ProgSTAR study visits to expand the collection of retinal images to include microperimetry measurements gathered under scotopic (low light) conditions.

Conditions

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Foundation Fighting Blindness

    lead OTHER

Principal Investigators

  • Hendrik Scholl, MD · Wilmer Eye Institute at the Johns Hopkins University

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • United States
  • France
  • Germany
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01977846 on ClinicalTrials.gov