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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

Tracking Information
First Submitted Date April 6, 2018
First Posted Date April 20, 2018
Last Update Posted Date May 29, 2019
Actual Study Start Date April 5, 2018
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 12, 2018)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03504540 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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 (PL-AMD)
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)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with lupus, treated or not with APS, with ou without "pseudo-drusen-like" deposits
Condition
  • Lupus Erythematosus
  • Lupus Erythematosus, Systemic
  • Age Related Macular Degeneration
Intervention Procedure: Blood test
Blood test for complement factors and genetic polymorphisms of AMD analysis
Study Groups/Cohorts
  • Case (with pseudo-drusen-like deposits)
    Patients with lupus, treated or not with antimalarial drugs, with "pseudo-drusen-like" deposits
    Intervention: Procedure: Blood test
  • Control (without pseudo-drusen-like deposits)
    Patients with lupus, treated or not with antimalarial drugs, without "pseudo-drusen-like" deposits
    Intervention: Procedure: Blood test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 12, 2018)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Laurence SALOMON 01.48.03.64.31 lsalomon@for.paris
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03504540
Other Study ID Numbers MMT_2018_1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Fondation Ophtalmologique Adolphe de Rothschild
Study Sponsor Fondation Ophtalmologique Adolphe de Rothschild
Collaborators Not Provided
Investigators
Principal Investigator: Martine MAUGET FAYSSE Fondation Ophtalmologique A. de Rothschild
PRS Account Fondation Ophtalmologique Adolphe de Rothschild
Verification Date May 2019