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)

May 21, 2021 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Fondation Ophtalmologique Adolphe de Rothschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with lupus, treated or not with APS, with ou without "pseudo-drusen-like" deposits

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of AMD genetic polymorphisms between case and control patients
Time Frame: Baseline
Baseline
Comparison of complement factors between case and control patients
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2018

Primary Completion (Actual)

May 15, 2021

Study Completion (Actual)

May 15, 2021

Study Registration Dates

First Submitted

April 6, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (Actual)

April 20, 2018

Study Record Updates

Last Update Posted (Actual)

May 24, 2021

Last Update Submitted That Met QC Criteria

May 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMT_2018_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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