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Monocentric Retrospective Observational Study on Patients With Macular Degeneration (ELOUAN)

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ClinicalTrials.gov Identifier: NCT02089503
Recruitment Status : Unknown
Verified March 2014 by QUEGUINER, MD, Hospital St. Joseph, Marseille, France.
Recruitment status was:  Not yet recruiting
First Posted : March 17, 2014
Last Update Posted : March 18, 2014
Sponsor:
Information provided by (Responsible Party):
QUEGUINER, MD, Hospital St. Joseph, Marseille, France

Tracking Information
First Submitted Date March 14, 2014
First Posted Date March 17, 2014
Last Update Posted Date March 18, 2014
Study Start Date March 2014
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 14, 2014)
Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks). [ Time Frame: measured at 24 months (± 4 weeks) ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 14, 2014)
the mean change of the BCVA throughout the 24 months of follow-up (FU), [ Time Frame: 24 months of follow-up ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Monocentric Retrospective Observational Study on Patients With Macular Degeneration
Official Title Monocentric Retrospective Observational Study Describing the Visual Acuity of Patients With Exudative Age Related Macular Degeneration and Treated by Lucentis® Under Real Conditions of Care.
Brief Summary Main Objective: The main objective of this retrospective observational study was to describe the evolution of visual acuity measured on ETDRS (Early Treatment Diabetic Retinopathy Study) scale, for patients with exudative Age-Related Macular Degeneration (ARMD), treated with Lucentis, under real conditions of care, in terms of mean change of the Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with exudative Age-Related Macular Degeneration (ARMD), treated with Lucentis, under real conditions of care
Condition Exudative Age-Related Macular Degeneration
Intervention Other: intravitreal injections of Lucentis
intravitreal injections FOR ALL PATIENTS of Lucentis as required in the normal condition of use
Study Groups/Cohorts
  • induction phase + intravitreal inj.
    Group of patients who received Lucentis ® with induction phase
    Intervention: Other: intravitreal injections of Lucentis
  • intravitreal inj. without induction
    Group of patients who received Lucentis ® without induction phase
    Intervention: Other: intravitreal injections of Lucentis
  • intravitreal inj. + monthly follow-up
    group of patients who were monthly monitored (+/- 1 week)
    Intervention: Other: intravitreal injections of Lucentis
  • intravitreal inj. + follow-up :> 1 month
    group of patients with Follow up visits intervals> 1 month (+/- 1 week)
    Intervention: Other: intravitreal injections of Lucentis
  • intravitreal inj +induction+ month. FU
    Group of patients who received Lucentis with induction phase and who were monthly monitored (+/- 1 week)
    Intervention: Other: intravitreal injections of Lucentis
  • date Lucentis® 1st intravitreal Inj.
    Group of patients selected in accordance with the date of Lucentis® treatment start.
    Intervention: Other: intravitreal injections of Lucentis
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 Unknown status
Estimated Enrollment
 (submitted: March 14, 2014)
250
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2014
Estimated Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with exudative-subfove ARMD, regardless the neovessel type or the initial visual acuity; 2 - Patients treated in the department with intra vitreous injection of Lucentis ® during the study period (08/2011 and 02/2013); 3 - If both eyes are eligible, both will be analyzed;

Exclusion Criteria:

  1. - Patients who received, for the studied eye, a treatment with a Vascular endothelial growth factor (VEGF) other than Lucentis ® in the three months preceding the start of the study. For those who received combination therapy, the nature of the treatment will be specified and taken into account in the subgroups for statistical analyzes;
  2. - Patients with high myopia or neovessel not related to exudative-ARMD;
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02089503
Other Study ID Numbers ELOUAN HSJ 2014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party QUEGUINER, MD, Hospital St. Joseph, Marseille, France
Study Sponsor Hospital St. Joseph, Marseille, France
Collaborators Not Provided
Investigators
Study Chair: Maud RIGHINI, MD HSJ
PRS Account Hospital St. Joseph, Marseille, France
Verification Date March 2014