An observational study in Retinitis Pigmentosa, sponsored by Shire. Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2021-03-17.
Sponsored by Shire · Observational
The purpose of this study is to gain an understanding of how adRP progresses over time in patients with misfolded rod opsin mutations.
250 studies on the registry are indexed under Retinitis; 28 are open to participants now.
This study's enrollment of 1 is below the median of 60 across 64 observational studies indexed under Retinitis.
Browse Retinitis studies →Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.
Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Study population will come from a clinical setting where a diagnosis of adRP has been made
The subject has at least 1 eye that meets all 3 of the following criteria:
Exclusion Criteria:
The subject has any of the following medical conditions that will interfere with consistent follow-up over any part of the study:
The subject has any of the following ocular conditions that could interfere with or confound follow-up of disease progression:
The subject currently requires the following protocol prohibited medications or has ingested such medication within 30 days of screening:
Plaquenil Thioridazine Clofazimine Deferoxamine Phenothiazine Chlorpromazine Cisplatin Valproic acid Any other drugs with known visual side effects
Observation of progression of disease over time.
Diagnostic Test: Observation
Observation of progression of disease over time
Progression of disease over time in adRP patients with misfolded rod opsin mutations using ellipsoid zone (EZ) area measurements
Time frame: Baseline to 4 years
Progression of disease over time in adRP patients with misfolded rod opsin mutations as measured by EZ width
Time frame: Baseline to 4 years
Progression of disease over time in adRP patients with misfolded rod opsin mutations as measured by visual fields (kinetic and static)
Time frame: Baseline to 4 years
Progression of disease over time in adRP patients with misfolded rod opsin mutations as measured by dark-adapted rod visual fields
Time frame: Baseline to 4 years
Progression of disease over time in adRP patients with misfolded rod opsin mutations as measured by electroretinography (ERG): dark- and light-adapted
Time frame: Baseline to 4 years
Progression of disease over time in adRP patients with misfolded rod opsin mutations as measured by best corrected visual acuity (BCVA)
Time frame: Baseline to 4 years
Vision-related function and quality of life as measured by 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) plus its additional items
Time frame: Baseline to 4 years
Plan to share: No — De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be re-identified (due to the limited number of study participants).
This study is terminated, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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