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NCT06803082: Amyloidosis

The Impact of Systemic Light Chain Amyloidosis on Eyes

Recruiting now Last updated 31 January 2025
What this trial tests

trial in Systemic Light Chain Amyloidosis in 130 participants. Currently enrolling.

Timeline
4 September 2024
Primary endpoint
13 August 2026
13 August 2026

Quick facts

Lead sponsorZhongshan Ophthalmic Center, Sun Yat-sen University
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment130
Start date4 September 2024
Primary completion13 August 2026
Estimated completion13 August 2026
Sites1 location across China

Conditions studied

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Who can join

Adults 18 to 80, any sex, with Systemic Light Chain Amyloidosis or Ocular Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Study Purpose and Principle: Amyloidosis is a group of diseases characterized by the deposition of amyloid proteins in tissues and organs throughout the body, with common affected organs including kidneys, heart, nervous system, gastrointestinal tract, and liver. Nowadays, nearly 40 different proteins have been found to form amyloid fibrils in body, among which Systemic Light Chain (AL) Amyloidosis is the most common type of systemic amyloidosis. AL amyloidosis is a plasma cell disorder, with its precursor protein originating from free light chains produced by abnormal plasma cell clones, which form amyloid substances that deposit in tissues and organs causing lesions. In terms of incidence, the incidence of AL amyloidosis is 8-10 cases per million person-years in the United States and is considered a rare disease in our country. AL amyloidosis has an insidious onset, diverse clinical manifestations, and is prone to misdiagnosis and missed diagnosis in clinical practice. The prognosis also has strong heterogeneity and is closely related to the extent of organ involvement at the time of diagnosis. In the past, the incidence of eye involvement in systemic AL amyloidosis patients was low, with various manifestations, only reported as case reports, and not regularly followed up with systemic treatment. Based on this, this project aims to assess the involvement of eyes and its appendages in patients with different stages of systemic light chain amyloidosis, with the goal of clarifying the ocular manifestations of this systemic disease and exploring early diagnostic indicators for the eye. Primary Objective: To assess the involvement of the anterior segment of the eye, as well as the extraocular soft tissues and muscles, in patients with systemic light chain amyloidosis. Secondary Objective: To assess the neuro-ophthalmic manifestations and changes in retinal choroidal blood flow in patients with systemic light chain amyloidosis. Study Design: Observational study. Study Population and Expected Enrollment: 80 patients with systemic light chain amyloidosis, 50 normal controls. Study Duration: Six months of follow-up after the last subject is diagnosed and enrolled. Intervention: Experimental Group: Patients with systemic light chain amyloidosis; Control Group: Subjects without systemic diseases.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Data sources for this page

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