- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07847151
MIND-AMD Study: a Multidisciplinary Investigation of Neuroretinal Damage in Age-related Macular Degeneration. (MIND-AMD)
Age-related macular degeneration (AMD) is the major cause of legal blindness in developed countries. Intermediate AMD represents the most frequent stage. However, it often evolves towards complicated stages, namely neovascular AMD or geographic atrophy (GA). Despite the available treatments, the visual outcome is highly heterogeneous. The scientific interest is growing regarding the assessment of neuroretinal changes in AMD. Although AMD is mainly considered an outer retinal disease, recent evidence suggests a major involvement of retinal glia and neurons, i.e. an involvement of the inner retina. This damage may remarkably affect the morphological and functional AMD outcome, subverting retinal signal transmission cascade and more clearly explaining the outcome of the disease. The main goal of this study is to perform a multidisciplinary, multicenter, both prospective and retrospective evaluation of neuroretinal degeneration in different AMD stages in preclinical and clinical models.
연구 개요
상태
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Alessandro Arrigo, MD, PhD
- 전화번호: +390226433580
- 이메일: arrigo.alessandro@hsr.it
연구 연락처 백업
- 이름: Adelaide Pina, MsC
- 이메일: pina.adelaide@hsr.it
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Patients affected by intermediate, wet and dry (geographic atrophy) age-related macular degeneration (AMD) and healthy age- and gender-matched controls
설명
Inclusion Criteria:
- Confirmed diagnosis of AMD
Exclusion Criteria:
- low BCVA (<20/100)
- other ocular diseases
- uncontrolled systemic diseases potentially affecting data interpretation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_CONTROL
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
|---|
|
Patients affected by AMD (different stages)
Patients affected by intermediate, wet and dry atrophic AMD |
|
Healthy controls
Healthy age- and gender-matched control |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Neuroretinal degeneration quantitative metrics
기간: From January 2027 to January 2030
|
Quantitative multimodal retinal imaging metrics associated with inner retinal changes and neuroretinal degeneration |
From January 2027 to January 2030
|
|
Imaging metrics of neuroretinal changes
기간: From January 2027 to January 2030
|
Multimodal retinal imaging metrics associated with inner retinal changes and neuroretinal degeneration |
From January 2027 to January 2030
|
|
MicroRNA profiles associated with AMD stages
기간: From January 2027 to January 2030
|
MicroRNAs different profiles associated with AMD stages, risk of progression and neuroretinal degeneration. |
From January 2027 to January 2030
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Alessandro Arrigo, MD, PhD, IRCCS San Raffaele Scientific Institute, Milan, Italy
간행물 및 유용한 링크
일반 간행물
- Nassisi M, Baghdasaryan E, Borrelli E, Ip M, Sadda SR. Choriocapillaris flow impairment surrounding geographic atrophy correlates with disease progression. PLoS One. 2019 Feb 22;14(2):e0212563. doi: 10.1371/journal.pone.0212563. eCollection 2019.
- Natoli R, Fernando N. MicroRNA as Therapeutics for Age-Related Macular Degeneration. Adv Exp Med Biol. 2018;1074:37-43. doi: 10.1007/978-3-319-75402-4_5.
- Nassisi M, Fan W, Shi Y, Lei J, Borrelli E, Ip M, Sadda SR. Quantity of Intraretinal Hyperreflective Foci in Patients With Intermediate Age-Related Macular Degeneration Correlates With 1-Year Progression. Invest Ophthalmol Vis Sci. 2018 Jul 2;59(8):3431-3439. doi: 10.1167/iovs.18-24143.
- Nassisi M, Lei J, Abdelfattah NS, Karamat A, Balasubramanian S, Fan W, Uji A, Marion KM, Baker K, Huang X, Morgenthien E, Sadda SR. OCT Risk Factors for Development of Late Age-Related Macular Degeneration in the Fellow Eyes of Patients Enrolled in the HARBOR Study. Ophthalmology. 2019 Dec;126(12):1667-1674. doi: 10.1016/j.ophtha.2019.05.016. Epub 2019 May 29.
- Nassisi M, Tepelus T, Corradetti G, Sadda SR. Relationship Between Choriocapillaris Flow and Scotopic Microperimetry in Early and Intermediate Age-related Macular Degeneration. Am J Ophthalmol. 2021 Feb;222:302-309. doi: 10.1016/j.ajo.2020.04.018. Epub 2020 Apr 28.
- Arrigo A, Aragona E, Battaglia Parodi M, Bandello F. Quantitative approaches in multimodal fundus imaging: State of the art and future perspectives. Prog Retin Eye Res. 2023 Jan;92:101111. doi: 10.1016/j.preteyeres.2022.101111. Epub 2022 Aug 4.
- Arrigo A, Aragona E, Bianco L, Antropoli A, Berni A, Saladino A, Cosi V, Bandello F, Battaglia Parodi M. The Localization of Intraretinal Cysts Has a Clinical Role on the 2-Year Outcome of Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2023 Dec;7(12):1069-1079. doi: 10.1016/j.oret.2023.07.025. Epub 2023 Jul 30.
- Arrigo A, Aragona E, Battaglia Parodi M, Bandello F. Quantitative Multimodal Imaging Characterization of Intraretinal Cysts versus Degenerative Pseudocysts in Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2024 Dec;8(12):1118-1126. doi: 10.1016/j.oret.2024.05.019. Epub 2024 Jun 6.
- Arrigo A, Saladino A, Aragona E, Barresi C, Mularoni C, Bandello F, Battaglia Parodi M. Clinical and Imaging Biomarkers Associated with Outer Retinal Atrophy Onset in Exudative Age-Related Macular Degeneration: A Real-Word Prospective Study. Ophthalmol Ther. 2024 May;13(5):1185-1196. doi: 10.1007/s40123-024-00903-4. Epub 2024 Mar 6.
- Arrigo A, Aragona E, Del Fabbro S, Balduzzi E, Parodi MB, Bandello F. Quantitative Optical Coherence Tomography Detection of New Neovascular Branches and Association With Exudation Recurrence in Neovascular Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci. 2024 Jun 3;65(6):30. doi: 10.1167/iovs.65.6.30.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- MIND-AMD
- GR-2024-12379726 (기타 보조금/기금 번호: Ministero della Salute)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Scientific publications and international conferences.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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