건성 연령 관련 황반변성의 광생체변조를 평가하기 위한 등록 연구(EUROIGHT)(EUROIGHT)
건성 연령 관련 황반변성 참가자의 광생체조절(Photobiomodulation)의 안전성과 유효성을 평가하기 위한 다기관 등록 연구(EUROLIGHT)
The purpose of this registry study is to collect real life data pertaining to the safety and clinical effectiveness of multi-wavelength photobiomodulation (PBM) as provided by the Valeda Light Delivery System in participants with dry age-related macular degeneration (AMD) in routine clinical practice. Data will be collected retrospectively and prospectively.
PBM involves the use of visible light to near infrared light (NIR) (500-1000 nanometers) produced by a laser or a non-coherent light source applied to the surface of the body to activate mitochondrial respiratory chain components, stabilize metabolic function, and promote cellular proliferation.
This registry study will be conducted in Europe, the US, and select other countries approved by their regulatory agency.
This registry study was initiated as a combined retrospective and prospective data collection effort. After the acquisition of LumiThera by Alcon Research, LLC in September 2025, the study was amended to prospectively collect data from U.S. sites starting in July 2026.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
In this multi-center registry study, each qualifying eye will or will have been treated with the Valeda Light Delivery System for a total of nine short, non-invasive treatments over a three-to-five-week period and retreated every four to six months for a total of up to six rounds of treatment, as determined by the investigator.
Participants are considered to have completed the study if they complete at least one full treatment round with Optical Coherence Tomography (OCT) imaging collected post treatment. Participation may last up to 31 months, or as determined by the Investigator as the duration between treatment rounds and number of treatment rounds may vary by participant based on the progression of the disease as determined by the Investigator.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Alcon Call Center
- 전화번호: 1-888-451-3937
- 이메일: alcon.medinfo@alcon.com
연구 장소
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Oslo, 노르웨이, 0366
- 모집하지 않고 적극적으로
- Institutt for Oyehelse
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California
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Beverly Hills, California, 미국, 90211
- 아직 모집하지 않음
- Retina Vitreous Associates Medical Group
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Ohio
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Cincinnati, Ohio, 미국, 45242
- 아직 모집하지 않음
- Cincinnati Eye Institute
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South Carolina
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Charleston, South Carolina, 미국, 29414
- 아직 모집하지 않음
- Carolina Eyecare Physicians
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Texas
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McAllen, Texas, 미국, 78503
- 모병
- Valley Retina Institute
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Washington
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Silverdale, Washington, 미국, 98383
- 아직 모집하지 않음
- Pacific Northwest Retina
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
The patient population for this study will consist of a target of at least 25 male and female participants per site of any ethnic background and with a diagnosis of dry AMD by the Investigator or confirmed by the Investigator. The participant must meet all the inclusion criteria, have none of the exclusion criteria, and give their written Informed Consent to participate in this clinical study.
Only if the participant is interested in participating, s/he would be given the option to sign the study consent and start the study procedures, or if retrospectively signing the informed consent form, have their data used in the study.
설명
Inclusion Criteria:
- Diagnosis or confirmation of diagnosis of dry AMD disease by Investigator;
- Able to communicate well with the Investigator and able to understand and comply with the requirements of the study;
- Informed of the nature of this study and has provided written, informed consent; (participants enrolled retrospectively will need to be contacted and sign an informed consent form prior to their data being used).
Exclusion Criteria:
- US Sites Only: Center-involving geographic atrophy;
- Neovascular maculopathy;
- Use of any photosensitizing agent (e.g. topicals, injectables) activated by the Valeda Light Deliver System within 30 days prior to treatment without consulting participant's physician;
- Known photosensitivity to yellow light, red light, or near infrared radiation (NIR), or has a history of light activated central nervous system disorders (e.g. epilepsy, migraine);
- In the opinion of the Investigator, is unlikely to comply with the study protocol or has a history or current evidence of any condition that, in the opinion of the investigator, might interfere with the participant's involvement in the trial, or is not in the best interest of the participant.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: OTHER
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
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Photobiomodulation (PBM)
Two alternating and sequential treatments with the Valeda Light Delivery System of 590 nm and 850 nm for 35 seconds, or a total of 70 seconds, followed by 660 nm for 90 seconds, or a total of 180 seconds |
FDA-approved, multi-wavelength light delivery system for providing a pre-set treatment of pulsed light in 3 distinct wavelengths (PBM) to the participant's eye and retinal tissue through the open and closed eyelid. The Valeda Light Delivery System is a CE Marked Class IIa device in Europe (Certificate # CE 653115) and a Class 2 device in the United States (DEN230083). |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Visual Acuity from Baseline at each Treatment Visit
기간: Baseline (Day 0) pre-treatment; up to Month 31/exit
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Visual acuity will be assessed prior to any PBM treatment (baseline) and at each treatment visit after PBM was delivered. |
Baseline (Day 0) pre-treatment; up to Month 31/exit
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Number of Adverse Events Associated with PBM Treatment
기간: Up to Month 31/exit
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The number of adverse events associated with PBM treatment will be reported. |
Up to Month 31/exit
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공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Sr. Principal Clinical Trial Operations, Surgical, Alcon Research, LLC
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- CSP006
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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