Systemic Light Chain AmyloidosisAmyloidosisNCT06803082
The Impact of Systemic Light Chain Amyloidosis on Eyes
An observational study of Systemic Light Chain Amyloidosis and Ocular Complications, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Light Chain Amyloidosis, Ocular Complications
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 4 Sep 2024to 13 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Source and Selection Method of Case Group: Patients diagnosed with "Systemic Light Chain Amyloidosis" or suspected of having "Systemic Light Chain Amyloidosis" and treated according to relevant diagnostic and treatment standards at tertiary hospitals. They are planned to undergo ocular screening at Zhongshan Ophthalmic Center of Sun Yat-sen University to exclude ocular and adnexal complications. It is expected that 80 cases of systemic light chain amyloidosis will participate in this study. Source and Selection Method of Control Group: Control group subjects are all sourced from the outpatient department of Zhongshan Ophthalmic Center of Sun Yat-sen University. It is expected that 50 cases of dry eye syndrome/cataract patients will participate in this study.
Who may be able to join
- Patients diagnosed with "Systemic Light Chain Amyloidosis";
- No other severe systemic underlying diseases that affect the examination;
- Subjects voluntarily participate in this study, sign the informed consent form;
- Age between 18-80 years old, no gender restrictions.
- Stable general condition, not patients with "Systemic Light Chain Amyloidosis";
- No other severe systemic underlying diseases that affect the examination;
- Subjects voluntarily participate in this study, sign the informed consent form;
- Age between 18-80 years old, no gender restrictions.
Who cannot join
- Patients with eye diseases of clear causes such as ocular surface malignant tumors, corneal perforation, severe eye trauma, etc.;
- Patients with nystagmus;
- Severe ocular scar diseases; conjunctival scars with fornix shortening;
- Current signs of infection, including fever and undergoing antibiotic treatment;
- Mental abnormalities;
- Pregnant or breastfeeding women, or women planning to become pregnant within 2 years;
Show all 15Show fewer
- NYHA Class IV: Heart disease patients cannot engage in any physical activity, with heart failure symptoms even at rest, and worsening with physical activity;
- NT-proBNP > 8,500 ng/L.
- Control Group
- Patients with eye diseases of clear causes such as ocular surface malignant tumors, corneal perforation, severe eye trauma, etc.;
- Patients with nystagmus;
- Severe ocular scar diseases; conjunctival scars with fornix shortening;
- Current signs of infection, including fever and undergoing antibiotic treatment;
- Mental abnormalities;
- Pregnant or breastfeeding women, or women planning to become pregnant within 2 years.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Opthalmic Center
Guangzhou, Guangdong
yanjie yan, 020-66610729, iacuc@gzzoc.com
About this study
Official title: The Impact of Systemic Light Chain Amyloidosis on Eyes and Its Appendages
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.
Read more
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.
- Keywords
- Systemic Light Chain Amyloidosis, Ocular Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | Exposed group: Ocular Complications of Systemic Light Chain Amyloidosis. Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression. | |
| Unexposed group | Unexposed group: patients without Systemic Light Chain Amyloidosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conjunctival Mass
Conjunctival Mass: The size of the yellowish-pink waxy mass on the bulbar or palpebral conjunctiva (if present, additional conjunctival confocal microscopy examination is performed to clarify the microscopic morphology of the mass).
Measured: Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Subconjunctival Hemorrhage Grading
Subconjunctival Hemorrhage: No conjunctival congestion is scored 0; mild diffuse conjunctival congestion is scored 1; moderate diffuse conjunctival congestion, with noticeable congestion near the fornices, is scored 2; severe diffuse conjunctival congestion with subconjunctival hemorrhage is scored 3.
Measured: Each system light chain amyloidosis patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Secondary outcomes (11)
Periocular Purpura
Purple-red macules and papules on the skin around the orbit.
Measured: Each system light chain amyloidosis patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Ptosis
Measure the degree to which the upper eyelid margin covers the cornea when both eyes are open and looking straight ahead. It is classified based on the degree of coverage: Mild: Coverage ≤4 mm, with a drooping amount of ≤2 mm; Moderate: Coverage >4～≤6 mm, drooping amount >2～≤4 mm; Severe: Coverage >6 mm, reaching the central part of the pupil, with a drooping amount >4 mm.
Measured: Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Vitreous Opacity
Fundus photography records the morphology of vitreous opacity, such as Weiss ring, flocculent, dense membranous, fine punctate, filamentous, reticular, etc.
Measured: Each system light chain amyloidosis patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Cup-to-Disc Ratio (C/D)
After mydriasis (pupil > 6 mm), in a dark room, a skilled professional technician uses a digital fundus camera to adjust the machine's height, the subject's head position, and seating. The subject is instructed to open their eyes and focus on the cursor inside the machine, and two directional fundus photographs are taken for each eye (centered on the macula and the optic disc, respectively).
Measured: Each system light chain amyloidosis patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Visual Field
The extent of visual field defects is assessed according to the HPA (Humphrey Perimetry Analysis) international visual field staging method. An average deviation of <-6dB is considered mild, -6dB ≤ average deviation ≤ -12dB is moderate, and an average deviation >-12dB is severe.
Measured: Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Retinal Microvasculature
OCTA measurement of superficial retinal vessel density in the foveal center (3mm)
Measured: Each system light chain amyloidosis patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Retinal Nerve Fiber Layer Thickness
Heidelberg OCT measurement of retinal nerve fiber layer thickness in the foveal center (6mm)
Measured: Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Choroidal Thickness
Heidelberg OCT measurement of choroidal thickness in the foveal center (6mm)
Measured: Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Cornea
Corneal Dystrophy: Mucous drop dystrophy and lattice dystrophy of the cornea. If present, anterior segment OCT (Optical Coherence Tomography) is performed to assist in determining the depth of corneal opacity and deposition.
Measured: Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Visual Acuity
Uncorrected distant visual acuity is assessed using a Snellen chart. If the uncorrected distant visual acuity is less than 1.0, additional tests including computerized refraction and corrected distant visual acuity are performed.
Measured: Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Non-contact Intraocular Pressure
The tonometer measures the intraocular pressure and displays the result on the screen, taking three consecutive measurements. If an erroneous value is detected, the subject rests and adjusts for 1 minute before repeating the intraocular pressure measurement three times to record the accurate data.
Measured: Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start4 Sep 2024
- Primary completion13 Aug 2026 (estimated)
- Study completion13 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Light Chain AmyloidosisStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- chang he, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803082
- Sponsor's protocol ID
- 2024KYPJ080
- Other IDs
- 82322016
- Acronym
- Amyloidosis
- Status last verified
- Aug 2024
- First submitted
- 13 Dec 2024
- Last updated
- 31 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Systemic Light Chain Amyloidosis on Eyes and Its Appendages
- ClinicalTrials.gov ID
- NCT06803082
- Acronym / sponsor ID
- Amyloidosis / 2024KYPJ080
- Keywords
- Systemic Light Chain Amyloidosis, Ocular Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 13 Aug 2026 (estimated)
- Study completion
- 13 Aug 2026 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | –Exposed group: Ocular Complications of Systemic Light Chain Amyloidosis. Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression. |
| Unexposed group | – | –Unexposed group: patients without Systemic Light Chain Amyloidosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Source and Selection Method of Case Group: Patients diagnosed with "Systemic Light Chain Amyloidosis" or suspected of having "Systemic Light Chain Amyloidosis" and treated according to relevant diagnostic and treatment standards at tertiary hospitals. They are planned to undergo ocular screening at Zhongshan Ophthalmic Center of Sun Yat-sen University to exclude ocular and adnexal complications. It is expected that 80 cases of systemic light chain amyloidosis will participate in this study. Source and Selection Method of Control Group: Control group subjects are all sourced from the outpatient department of Zhongshan Ophthalmic Center of Sun Yat-sen University. It is expected that 50 cases of dry eye syndrome/cataract patients will participate in this study.
Key inclusion criteria (8 listed)
- Patients diagnosed with "Systemic Light Chain Amyloidosis";
- No other severe systemic underlying diseases that affect the examination;
- Subjects voluntarily participate in this study, sign the informed consent form;
- Age between 18-80 years old, no gender restrictions.
- Stable general condition, not patients with "Systemic Light Chain Amyloidosis";
Key exclusion criteria (15 listed)
- Patients with eye diseases of clear causes such as ocular surface malignant tumors, corneal perforation, severe eye trauma, etc.;
- Patients with nystagmus;
- Severe ocular scar diseases; conjunctival scars with fornix shortening;
- Current signs of infection, including fever and undergoing antibiotic treatment;
- Mental abnormalities;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Conjunctival Mass
Time frame: Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Conjunctival Mass: The size of the yellowish-pink waxy mass on the bulbar or palpebral conjunctiva (if present, additional conjunctival confocal microscopy examination is performed to clarify the microscopic morphology of the mass).
Subconjunctival Hemorrhage Grading
Time frame: Each system light chain amyloidosis patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Subconjunctival Hemorrhage: No conjunctival congestion is scored 0; mild diffuse conjunctival congestion is scored 1; moderate diffuse conjunctival congestion, with noticeable congestion near the fornices, is scored 2; severe diffuse conjunctival congestion with subconjunctival hemorrhage is scored 3.
11 secondary outcomes
Periocular Purpura
Time frame: Each system light chain amyloidosis patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Ptosis
Time frame: Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Vitreous Opacity
Time frame: Each system light chain amyloidosis patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Cup-to-Disc Ratio (C/D)
Time frame: Each system light chain amyloidosis patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Visual Field
Time frame: Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Retinal Microvasculature
Time frame: Each system light chain amyloidosis patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Retinal Nerve Fiber Layer Thickness
Time frame: Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Choroidal Thickness
Time frame: Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Cornea
Time frame: Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Visual Acuity
Time frame: Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Non-contact Intraocular Pressure
Time frame: Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
chang he principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Light Chain Amyloidosis and Ocular Complications, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minglu Ma, Doctor (86-13547891481, mingluma@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conjunctival Mass (time frame: Each patient will be followed up once every 2 months, for a total of 4 follow-ups, over a 6-month period, to observe any ocular complications and progression.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.