臨床研究等提出・公開システム

Date of registration	Jan. 15, 2025
Last modified on	June. 05, 2026
Trial ID	jRCT2033240611

Scientific Title	Open-Label, Dose Escalation, Single-dose Study of RV-001 in Subjects with Retinitis Pigmentosa (Phase I/II)
Public Title	Phase I/II Study for RV-001

Contact for Scientific Queries	Name	Katada Yusaku
	Affiliation	Restore Vision Inc.
	Address	Toranomon Hills Business Tower 15F, 1-17-1 Toranomon, Minato-ku, Tokyo
	Telephone	+81-90-5068-2405
	E-mail	chiken@restore-vis.com
Contact for Public Queries	Name	Katada Yusaku
	Affiliation	Restore Vision Inc.
	Address	Toranomon Hills Business Tower 15F, 1-17-1 Toranomon, Minato-ku, Tokyo
	Telephone	+81-90-5068-2405
	E-mail	chiken@restore-vis.com

Recruitment status	Recruiting


Anticipated date of first enrollment		Feb. 01, 2025
Target sample size		45
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	18 years old and up at the time of ICF signature Diagnosis of non-syndromic Retinitis Pigmentosa
	Exclusion Criteria	Diagnosed with an inherited retinal degenerative disease other than non-syndromic Retinitis Pigmentosa or systemic symptoms, such as hearing loss. Prior receipt of any genetic, cell-based or optogenetic therapy for Retinitis Pigmentosa, or prior participation in clinical trials for such therapies.
	Age Minimum	18age old over
	Age Maximum	No limit
Health Condition(s) or Problem(s) Studied		Retinitis Pigmentosa
Intervention(s)		Administration of investigational product
Primary Outcome(s)		Dose-Limiting Toxicity

Primary Sponsor	Restore Vision Inc.

Secondary Sponsor

Name of Certified Review Board	Keio University Hospital Institutional Review Board
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
Approval Status	Approval
Date of approval	Dec. 27, 2024

Name of Certified Review Board	Kobe City Medical Center General Hospital Institutional Review Board
Address	2-1-1, Minatojima-minamimachi, Chuo-ku, Kobe-city, Tokyo
Approval Status	Approval
Date of approval	Dec. 27, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	None

History of Changes

No	Publication date
3	June. 05, 2026	(this page)	Changes
2	Jan. 27, 2025	Detail	Changes
1	Jan. 15, 2025	Detail

List of change history