Lupus ErythematosusPL-AMDNCT03504540
Comparison of Complement Factors and Genetic Polymorphisms of AMD Between Patients With Systemic Lupus Erythematosus (SLE) With and Without Retinal "Pseudo-drusen-like" Deposits: Case-control Study (PL-AMD)
An observational study of Lupus Erythematosus and Lupus Erythematosus, Systemic, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The rationale of this research is to determine if patients with lupus and presenting retinal "pseudo-drusen-like" deposits have genetic and complement-related similarities with AMD patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Lupus Erythematosus, Lupus Erythematosus, Systemic, Age Related Macular Degeneration
- What is being tested?
- Blood test
- Type of treatment
- Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2018to 15 May 2021
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with lupus, treated or not with APS, with ou without "pseudo-drusen-like" deposits
Who may be able to join
- Systemic lupus erythematosus
- Case patients : with "pseudo-drusen-like" deposit
- Control patients : without "pseudo-drusen-like" deposit
Who cannot join
- Patient under a measure of legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Complement Factors and Genetic Polymorphisms of AMD Between Patients With Systemic Lupus Erythematosus (SLE) With and Without Retinal "Pseudo-drusen-like" Deposits: Case-control Study (PLAMD)
The rationale of this research is to determine if patients with lupus and presenting retinal "pseudo-drusen-like" deposits have genetic and complement-related similarities with AMD patients.
Based on the results obtained, this study could lead to future research that could better target the treatment of patients with lupus or patients with AMD (Age related Macular Degeneration).
The primary objective is to check if patients with lupus, treated or not with antimalarial drugs, with "pseudo-drusen-like" deposits have a different complement profile (functional exploration of complement, complement factors, genetic complement polymorphisms involved in AMD) compared to patients without "pseudo-drusen-like" deposits.
- Being tested
- Blood test
- Keywords
- Lupus Erythematosus, Systemic, Age Related Macular Degeneration, "Pseudo-drusen-like" deposits
- Medical subject headings
- Lupus Erythematosus, Systemic, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testProcedure or surgery
Blood test for complement factors and genetic polymorphisms of AMD analysis
| Study group | Role | What they receive |
|---|---|---|
| Case (with pseudo-drusen-like deposits) | Patients with lupus, treated or not with antimalarial drugs, with "pseudo-drusen-like" deposits Receives: Procedure: Blood test | |
| Control (without pseudo-drusen-like deposits) | Patients with lupus, treated or not with antimalarial drugs, without "pseudo-drusen-like" deposits Receives: Procedure: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of AMD genetic polymorphisms between case and control patients
Measured: Baseline
Comparison of complement factors between case and control patients
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start5 Apr 2018
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus ErythematosusStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Martine MAUGET FAYSSE, Principal investigator, Fondation Ophtalmologique A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504540
- Sponsor's protocol ID
- MMT_2018_1
- Acronym
- PL-AMD
- Status last verified
- May 2021
- First submitted
- 6 Apr 2018
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Complement Factors and Genetic Polymorphisms of AMD Between Patients With Systemic Lupus Erythematosus (SLE) With and Without Retinal "Pseudo-drusen-like" Deposits: Case-control Study (PLAMD)
- ClinicalTrials.gov ID
- NCT03504540
- Acronym / sponsor ID
- PL-AMD / MMT_2018_1
- Keywords
- Lupus Erythematosus, Systemic, Age Related Macular Degeneration, "Pseudo-drusen-like" deposits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 20 Apr 2018 (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.
The rationale of this research is to determine if patients with lupus and presenting retinal "pseudo-drusen-like" deposits have genetic and complement-related similarities with AMD patients.
Based on the results obtained, this study could lead to future research that could better target the treatment of patients with lupus or patients with AMD (Age related Macular Degeneration).
The primary objective is to check if patients with lupus, treated or not with antimalarial drugs, with "pseudo-drusen-like" deposits have a different complement profile (functional exploration of complement, complement factors, genetic complement polymorphisms involved in AMD) compared to patients without "pseudo-drusen-like" deposits.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case (with pseudo-drusen-like deposits) | – | Procedure: Blood testPatients with lupus, treated or not with antimalarial drugs, with "pseudo-drusen-like" deposits |
| Control (without pseudo-drusen-like deposits) | – | Procedure: Blood testPatients with lupus, treated or not with antimalarial drugs, without "pseudo-drusen-like" deposits |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with lupus, treated or not with APS, with ou without "pseudo-drusen-like" deposits
Key inclusion criteria (3 listed)
- Systemic lupus erythematosus
- Case patients : with "pseudo-drusen-like" deposit
- Control patients : without "pseudo-drusen-like" deposit
Key exclusion criteria (1 listed)
- Patient under a measure of legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testBlood test for complement factors and genetic polymorphisms of AMD analysis | Procedure or surgery | Case (with pseudo-drusen-like deposits), Control (without pseudo-drusen-like deposits) |
Primary outcome
Comparison of AMD genetic polymorphisms between case and control patients
Time frame: Baseline
Comparison of complement factors between case and control patients
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Individual participant dataSharing planned: Undecided
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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.
Martine MAUGET FAYSSE principal investigator
Fondation Ophtalmologique A. de Rothschild
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 Lupus Erythematosus and Lupus Erythematosus, Systemic, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 24 May 2021. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of AMD genetic polymorphisms between case and control patients (time frame: Baseline). 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 24 May 2021.