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NCT06803082: Amyloidosis
The Impact of Systemic Light Chain Amyloidosis on Eyes
trial in Systemic Light Chain Amyloidosis in 130 participants. Currently enrolling.
13 August 2026
Quick facts
| Lead sponsor | Zhongshan Ophthalmic Center, Sun Yat-sen University |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 130 |
| Start date | 4 September 2024 |
| Primary completion | 13 August 2026 |
| Estimated completion | 13 August 2026 |
| Sites | 1 location across China |
Conditions studied
- Systemic Light Chain Amyloidosis — all drugs for Systemic Light Chain Amyloidosis →
- Ocular Complications — all drugs for Ocular Complications →
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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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06803082 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zhongshan Ophthalmic Center, Sun Yat-sen University
- Last refreshed: 31 January 2025
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