National Hospital Organization Tokyo Medical Center
Meguro-ku, 1528902, Japan
NCT Number: NCT05926583
The purpose of the study is to assess the safety and tolerability of bilateral subretinal delivery of adeno-associated virus vector with a serotype 5 capsid human rhodopsin kinase promoter. retinitis pigmentosa guanosine triphosphatase regulator (AAV5-hRKp.RPGR).
This study is active but is not currently recruiting participants.
5 year and older
All sexes
Interventional
Phase 3
Meguro-ku, 1528902, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AAV5-hRKp.RPGR will be administered by subretinal injection using a standardized surgical procedure.
Time frame: Up to 60 Months
An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.
Time frame: Up to 60 Months
Number of participants with abnormalities in clinical laboratory assessment (hematology and serum chemistry) will be reported.
Time frame: Baseline - Week 52
Change from baseline in low luminance visual acuity by ETDRS chart score in monocular assessment at week 52 will be reported.
Time frame: Baseline - Week 52
Change from baseline in BCVA by ETDRS chart letter score in monocular assessment at week 52 will be reported.
Time frame: Baseline - Week 52
Change from baseline in low luminance visual acuity by ETDRS chart letter score in worse-seeing eye at week 52 will be reported.
Janssen Pharmaceutical K.K.
Industry
Phase 3 Study to Evaluate the Safety and Efficacy of AAV5-hRKp.RPGR for the Treatment of Japanese X-linked Retinitis Pigmentosa Associated With Pathogenic Variants in Retinitis Pigmentosa GTPase Regulator (RPGR)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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