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NCT01977846 · ClinicalTrials.gov registry record
A Natural History of the Progression of Stargardt Disease: Retrospective and Prospective Studies
A clinical trial, sponsored by Foundation Fighting Blindness.
- Completed
- Registry status
- 259
- Enrollment target
NCT01977846: Completed study, sponsored by Foundation Fighting Blindness.
NCT01977846 is a clinical trial that has completed, run by Foundation Fighting Blindness. The registered enrollment target is 259 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01977846 has completed, sponsored by Foundation Fighting Blindness.
- COMPLETED
- Registry status
- 259 participants
- Enrollment target
Study 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.
Primary Outcome
Yearly increase in area of decreased auto-fluorescence (DAF) which is defined as the sum of definite and questionable decreased auto-fluorescence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 259 participants |
| Start Date | 2013-08 |
| Est. Completion | 2017-02 |
What the finished NCT01977846 record still lists
NCT01977846 is an observational study that tracks outcomes without assigning an intervention. The registered 259 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01977846 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01977846 about?
NCT01977846 is a clinical study titled "A Natural History of the Progression of Stargardt Disease: Retrospective and Prospective Studies". 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 di...
What is the current status of trial NCT01977846?
This trial is currently completed. The enrollment target is 259 participants. The study started on 2013-08. Estimated completion is 2017-02.
Who is sponsoring clinical trial NCT01977846?
This trial is sponsored by Foundation Fighting Blindness, which has 3 total clinical trials registered on ClinicalTrials.gov.
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