臨床研究等提出・公開システム

Date of registration	May. 27, 2024
Last modified on	Feb. 20, 2025
Trial ID	jRCT2073240017

Scientific Title	[M23-409] A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD (ASCENT)
Public Title	Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD (ASCENT) (ASCENT)

Contact for Scientific Queries	Name	Tetsuya Otani
	Affiliation	AbbVie GK
	Address	3-2-1 Shibaura, Minato-ku, Tokyo
	Telephone	+81-120-587-874
	E-mail	AbbVie_JPN_info_clingov@abbvie.com
Contact for Public Queries	Name	Contact for Patients and HCP
	Affiliation	AbbVie GK
	Address	3-2-1 Shibaura, Minato-ku, Tokyo
	Telephone	+81-120-587-874
	E-mail	AbbVie_JPN_info_clingov@abbvie.com

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 01, 2024
Target sample size		14
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Age >= 50 years and <= 89 years 2. An ETDRS BCVA letter score between 78 and 40 in the study eye 3. Diagnosis of subfoveal CNV secondary to AMD in the study eye previously treated with anti-VEGF 4. Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye. 5. Willing and able to provide written, signed informed consent for this study 6. Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry
	Exclusion Criteria	1. CNV or macular edema in the study eye secondary to any causes other than AMD 2. Subfoveal fibrosis or atrophy in the study eye 3. Any condition in the investigator's opinion that could limit VA improvement in the study eye 4. Active or history of retinal detachment or current retinal tear in the study eye 5. Advanced glaucoma or history of secondary glaucoma in the study eye 6. Myocardial infarction, cerebrovascular accident, or transient ischemic attach within the past 6 months. 7. History of intraocular surgery in the study eye within 12 weeks prior to Screening Visit 1 8. History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit 1. 9. Prior treatment with gene therapy.
	Age Minimum	50age old over
	Age Maximum	89age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Neovascular age-related macular degeneration
Intervention(s)		RGX-314 Dose 1 AAV8 vector containing a transgene for anti-VEGF Fab (Dose1) RGX-314 Dose 2 AAV8 vector containing a transgene for anti-VEGF Fab (Dose2) Aflibercept (EYLEA) 2.0 mg (0.05 mLsolution) administered by intravitreal injection approximately every 8 weeks after 3 monthly injections
Primary Outcome(s)		Mean change from baseline in Best Corrected Visual Acuity (BCVA) [Time Frame: At Week 54]

Primary Sponsor	AbbVie GK

Source of Monetary Support	REGENXBIO Inc.
Secondary Sponsor	Applicable

Name of Certified Review Board	University of Miyazaki Hospital Institutional Review Board
Address	5200 Kiyotakecho Kihara, Miyazaki-city, Miyazaki
Telephone	+81-985-85-9852
E-Mail	chiken-jimu@med.miyazaki-u.ac.jp
Approval Status	Approval
Date of approval	Nov. 24, 2023

Plan to share IPD	No

Secondary ID(s)	NCT05407636
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	United States/Puerto Rico/Canada/France/Germany/ Hungary/Israel/Italy/Spain/United Kingdom

History of Changes

No	Publication date
2	Feb. 20, 2025	(this page)	Changes
1	May. 27, 2024	Detail

List of change history