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)

Sponsor
Fondation Ophtalmologique Adolphe de Rothschild (Other)
Overall Status
Completed
CT.gov ID
NCT03504540
Collaborator
(none)
42
1
37.3
1.1

Study Details

Study Description

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 Phase
  • Procedure: Blood test

Study Design

Study Type:
Observational
Actual Enrollment :
42 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 :
Apr 5, 2018
Actual Primary Completion Date :
May 15, 2021
Actual Study Completion Date :
May 15, 2021

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Comparison of AMD genetic polymorphisms between case and control patients [Baseline]

  2. Comparison of complement factors between case and control patients [Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondation ophtalmologique Adolphe de Rothschild Paris France 75019

Sponsors and Collaborators

  • Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Martine MAUGET FAYSSE, Fondation Ophtalmologique A. de Rothschild

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier:
NCT03504540
Other Study ID Numbers:
  • MMT_2018_1
First Posted:
Apr 20, 2018
Last Update Posted:
May 24, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2021