臨床研究等提出・公開システム

Date of registration	June. 02, 2026
Last modified on	June. 03, 2026
Trial ID	jRCT1050260065

Scientific Title	Investigation of the association between ophthalmological findings and vision-related quality of life in geographic atrophy secondary to age-related macular degeneration.
Public Title	Investigation of the association between ophthalmological findings and vision-related quality of life in geographic atrophy secondary to age-related macular degeneration.

Contact for Scientific Queries	Name	Tsujikawa Akitaka
	Affiliation	KYOTO UNIVERSITY HOSPITAL
	Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto-shi, Kyoto
	Telephone	+81-75-751-3248
	E-mail	tujikawa@kuhp.kyoto-u.ac.jp
Contact for Public Queries	Name	Tsujikawa Akitaka
	Affiliation	KYOTO UNIVERSITY HOSPITAL
	Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto-shi, Kyoto
	Telephone	+81-75-751-3248
	E-mail	tujikawa@kuhp.kyoto-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 02, 2026
Actual date of first enrollment		June. 03, 2026
Target sample size		198
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	factorial assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	- Patients with unilateral or bilateral atrophic age-related macular degeneration - Adults aged >=18 years living in Japan and understanding Japanese - Patients with atrophic age-related macular degeneration who are treatment-naive or previously or currently treated within the approved label (indication, dosage and administration)
	Exclusion Criteria	- Patients with macular neovascularization with active lesions and unstable disease - Patients with vision impairment or visual field defects in at least one eye due to diseases other than AMD (macular diseases, retinal diseases, glaucoma, optic nerve diseases, amblyopia, etc.) - Patients with high myopia (axial length >=26.5 mm) in at least one eye - Patients with cognitive impairment who cannot understand the questionnaire - Patients currently participating in other clinical trials
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Atrophic age-related macular degeneration
Primary Outcome(s)		Descriptive statistics of ophthalmological clinical findings and patient characteristics, and comparison of QOL scores

Primary Sponsor	Japanese Retina and Vitreous Society

Source of Monetary Support	Astellas Pharma Inc.
Secondary Sponsor	Applicable

Name of Certified Review Board	Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address	53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto, Kyoto
Telephone	+81-75-366-7618
E-Mail	ethcom@kuhp.kyoto-u.ac.jp
Approval Status	Approval

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	June. 03, 2026	(this page)	Changes
1	June. 02, 2026	Detail

List of change history