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

Hospital Saint Joseph

Status: Unknown

Conditions: Exudative Age-Related Macular Degeneration

Treatments: Other: intravitreal injections of Lucentis

Study type: Observational

Funder types: Other

Identifiers

NCT02089503

ELOUAN HSJ 2014

Details and patient eligibility

About

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).

Enrollment: 250 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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;

Trial design

250 participants in 6 patient groups

induction phase + intravitreal inj.

Description:

Group of patients who received Lucentis ® with induction phase

Treatment:

Other: intravitreal injections of Lucentis

intravitreal inj. without induction

Description:

Group of patients who received Lucentis ® without induction phase

Treatment:

Other: intravitreal injections of Lucentis

intravitreal inj. + monthly follow-up

Description:

group of patients who were monthly monitored (+/- 1 week)

Treatment:

Other: intravitreal injections of Lucentis

intravitreal inj. + follow-up :> 1 month

Description:

group of patients with Follow up visits intervals\> 1 month (+/- 1 week)

Treatment:

Other: intravitreal injections of Lucentis

intravitreal inj +induction+ month. FU

Description:

Group of patients who received Lucentis with induction phase and who were monthly monitored (+/- 1 week)

Treatment:

Other: intravitreal injections of Lucentis

date Lucentis® 1st intravitreal Inj.

Description:

Group of patients selected in accordance with the date of Lucentis® treatment start.

Treatment:

Other: intravitreal injections of Lucentis