NCT03504540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 6, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

May 24, 2021

Status Verified

May 1, 2021

Enrollment Period

3.1 years

First QC Date

April 6, 2018

Last Update Submit

May 21, 2021

Conditions

Keywords

Lupus Erythematosus, SystemicAge Related Macular Degeneration"Pseudo-drusen-like" deposits

Outcome Measures

Primary Outcomes (2)

  • Comparison of AMD genetic polymorphisms between case and control patients

    Baseline

  • Comparison of complement factors between case and control patients

    Baseline

Study Arms (2)

Case (with pseudo-drusen-like deposits)

Patients with lupus, treated or not with antimalarial drugs, with "pseudo-drusen-like" deposits

Procedure: Blood test

Control (without pseudo-drusen-like deposits)

Patients with lupus, treated or not with antimalarial drugs, without "pseudo-drusen-like" deposits

Procedure: Blood test

Interventions

Blood testPROCEDURE

Blood test for complement factors and genetic polymorphisms of AMD analysis

Case (with pseudo-drusen-like deposits)Control (without pseudo-drusen-like deposits)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patient under a measure of legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation ophtalmologique Adolphe de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Lupus Erythematosus, SystemicMacular Degeneration

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Martine MAUGET FAYSSE

    Fondation Ophtalmologique A. de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2018

First Posted

April 20, 2018

Study Start

April 5, 2018

Primary Completion

May 15, 2021

Study Completion

May 15, 2021

Last Updated

May 24, 2021

Record last verified: 2021-05

Locations