Monocentric Retrospective Observational Study on Patients With Macular Degeneration

NCT ID: NCT02089503

Last Updated: 2014-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-12-31

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).

Conditions

Exudative Age-Related Macular Degeneration

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

induction phase + intravitreal inj.

Group of patients who received Lucentis ® with induction phase

intravitreal injections of Lucentis

Intervention Type: OTHER

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

intravitreal injections of Lucentis

Intervention Type: OTHER

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)

intravitreal injections of Lucentis

Intervention Type: OTHER

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)

intravitreal injections of Lucentis

Intervention Type: OTHER

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)

intravitreal injections of Lucentis

Intervention Type: OTHER

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.

intravitreal injections of Lucentis

Intervention Type: OTHER

intravitreal injections FOR ALL PATIENTS of Lucentis as required in the normal condition of use

Interventions

intravitreal injections of Lucentis

intravitreal injections FOR ALL PATIENTS of Lucentis as required in the normal condition of use

Intervention Type: OTHER

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;

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital St. Joseph, Marseille, France

OTHER

Sponsor Role: lead

Responsible Party

QUEGUINER, MD

Ophtalmologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maud RIGHINI, MD

Role: STUDY_CHAIR

HSJ

Locations

Hopital Saint Joseph

Marseille, , France

Countries

France

Central Contacts

Frederic QUEGUINER, MD

Role: CONTACT

fqueguiner@hopital-saint-joseph.fr

+33491806793

Facility Contacts

Frederic QUEGUINER, MD

Role: primary

Other Identifiers

ELOUAN HSJ 2014

Identifier Type: -

Identifier Source: org_study_id