Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517940
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
A Prospective Observational Study in Adults With Retinitis Pigmentosa RP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Observational Study in Adults With Retinitis Pigmentosa RP
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The natural history in individuals with severe retinitis pigmentosa RP is variable and there remains an unmet need to better understand disease progression in this population The goal of this study is to determine which visual assessments individuals with RP and low visual acuity can reliably perform and to evaluate the annual decline of visual function in severe RP
Detailed Description:
This is a 12-month single-center prospective observational study in adults with RP Approximately 12 subjects will be enrolled into the Observation Period
The primary objective of this study is to determine which visual assessments RP subjects with low visual acuity can reliably perform Other objectives are 1 to determine which visual assessments are most sensitive to annual change in RP subjects with low visual acuity 2 to evaluate adverse events 3 to evaluate the safety and tolerability of study assessment procedures and 4 to evaluate the subjects experience in this study relevance of visual assessments and patient-reported outcome measures and perception of improvement in visual function
The primary objective of this study is to determine which visual assessments RP subjects with low visual acuity can reliably perform Other objectives are 1 to determine which visual assessments are most sensitive to annual change in RP subjects with low visual acuity 2 to evaluate adverse events 3 to evaluate the safety and tolerability of study assessment procedures and 4 to evaluate the subjects experience in this study relevance of visual assessments and patient-reported outcome measures and perception of improvement in visual function
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None