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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

Study Description
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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).

Condition or disease Intervention/treatment
Exudative Age-Related Macular Degeneration Other: intravitreal injections of Lucentis

Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Retrospective
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.
Study Start Date : March 2014
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
induction phase + intravitreal inj.
Group of patients who received Lucentis ® with induction phase
 Other: intravitreal injections of Lucentis
intravitreal injections FOR ALL PATIENTS of Lucentis as required in the normal condition of use
intravitreal inj. without induction
Group of patients who received Lucentis ® without induction phase
 Other: intravitreal injections of Lucentis
intravitreal injections FOR ALL PATIENTS of Lucentis as required in the normal condition of use
intravitreal inj. + monthly follow-up
group of patients who were monthly monitored (+/- 1 week)
 Other: intravitreal injections of Lucentis
intravitreal injections FOR ALL PATIENTS of Lucentis as required in the normal condition of use
intravitreal inj. + follow-up :> 1 month
group of patients with Follow up visits intervals> 1 month (+/- 1 week)
 Other: intravitreal injections of Lucentis
intravitreal injections FOR ALL PATIENTS of Lucentis as required in the normal condition of use
intravitreal inj +induction+ month. FU
Group of patients who received Lucentis with induction phase and who were monthly monitored (+/- 1 week)
 Other: intravitreal injections of Lucentis
intravitreal injections FOR ALL PATIENTS of Lucentis as required in the normal condition of use
date Lucentis® 1st intravitreal Inj.
Group of patients selected in accordance with the date of Lucentis® treatment start.
 Other: intravitreal injections of Lucentis
intravitreal injections FOR ALL PATIENTS of Lucentis as required in the normal condition of use


Outcome Measures
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Primary Outcome Measures :
  1. Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks). [ Time Frame: measured at 24 months (± 4 weeks) ]

Secondary Outcome Measures :
  1. the mean change of the BCVA throughout the 24 months of follow-up (FU), [ Time Frame: 24 months of follow-up ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with exudative Age-Related Macular Degeneration (ARMD), treated with Lucentis, under real conditions of care
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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089503


Contacts
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Contact: Frederic QUEGUINER, MD +33491806793 fqueguiner@hopital-saint-joseph.fr

Locations
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France
Hopital Saint Joseph
Marseille, France, 13008
Contact: Frederic QUEGUINER, MD         
Principal Investigator: Frederic QUEGUINER, MD         
Sponsors and Collaborators
Hospital St. Joseph, Marseille, France
Investigators
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Study Chair: Maud RIGHINI, MD HSJ
More Information
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Responsible Party: QUEGUINER, MD, Ophtalmologist, Hospital St. Joseph, Marseille, France
ClinicalTrials.gov Identifier: NCT02089503    
Other Study ID Numbers: ELOUAN HSJ 2014
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 18, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents