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

• ClinicalTrials.gov Identifier: NCT02089503
• Recruitment Status: Unknown
• First Posted: March 17, 2014
• Last Update Posted: March 18, 2014
• Sponsor: Hospital St. Joseph, Marseille, France
• 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
• 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

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

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