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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) (PL-AMD)

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ClinicalTrials.gov Identifier: NCT03504540
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief 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.

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.


Condition or disease Intervention/treatment
Lupus Erythematosus Lupus Erythematosus, Systemic Age Related Macular Degeneration Procedure: Blood test

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
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)
Actual Study Start Date : April 5, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Case (with pseudo-drusen-like deposits)
Patients with lupus, treated or not with antimalarial drugs, with "pseudo-drusen-like" deposits
Procedure: Blood test
Blood test for complement factors and genetic polymorphisms of AMD analysis

Control (without pseudo-drusen-like deposits)
Patients with lupus, treated or not with antimalarial drugs, without "pseudo-drusen-like" deposits
Procedure: Blood test
Blood test for complement factors and genetic polymorphisms of AMD analysis




Primary Outcome Measures :
  1. Comparison of AMD genetic polymorphisms between case and control patients [ Time Frame: Baseline ]
  2. Comparison of complement factors between case and control patients [ Time Frame: Baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with lupus, treated or not with APS, with ou without "pseudo-drusen-like" deposits
Criteria

Inclusion Criteria:

  • Systemic lupus erythematosus
  • Case patients : with "pseudo-drusen-like" deposit
  • Control patients : without "pseudo-drusen-like" deposit

Exclusion Criteria:

  • Patient under a measure of legal protection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504540


Contacts
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Contact: Laurence SALOMON 01.48.03.64.31 lsalomon@for.paris

Locations
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France
Fondation ophtalmologique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Martine MAUGET FAYSSE       mmfaysse@for.paris   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Principal Investigator: Martine MAUGET FAYSSE Fondation Ophtalmologique A. de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT03504540     History of Changes
Other Study ID Numbers: MMT_2018_1
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild:
Lupus Erythematosus, Systemic
Age Related Macular Degeneration
"Pseudo-drusen-like" deposits
Additional relevant MeSH terms:
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Macular Degeneration
Lupus Erythematosus, Systemic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Complement System Proteins
Immunologic Factors
Physiological Effects of Drugs