NCT06517940

A Prospective, Observational Study in Adults With Retinitis Pigmentosa (RP)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 12 (estimated)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 subject's experience in this study, relevance of visual assessments and patient-reported outcome measures, and perception of improvement in visual function.

Conditions

• Retinitis Pigmentosa

Timeline

• Start date: 2024-10-03
• Primary completion: 2026-04-24
• Completion: 2026-04-24
• First posted: 2024-07-24
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States