Monocentric Retrospective Observational Study on Patients With Macular Degeneration

• Conditions: Exudative Age-Related Macular Degeneration
• Interventions: Other: intravitreal injections of Lucentis

• Registration Number: NCT02089503
• Lead Sponsor: Hospital St. Joseph, Marseille, France

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 available

Study Timeline

• Status Verified: 2014-03
• Study Start: 2014-03
• Study First Submitted: 2014-03-14
• Study First Submitted QC: 2014-03-14
• Study First Posted: 2014-03-17
• Last Update Submitted: 2014-03-17
• Last Update Posted: 2014-03-18
• Primary Completion: 2014-05
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
induction phase + intravitreal inj.	intravitreal injections of Lucentis	Group of patients who received Lucentis ® with induction phase
intravitreal inj. without induction	intravitreal injections of Lucentis	Group of patients who received Lucentis ® without induction phase
intravitreal inj. + monthly follow-up	intravitreal injections of Lucentis	group of patients who were monthly monitored (+/- 1 week)
intravitreal inj. + follow-up :> 1 month	intravitreal injections of Lucentis	group of patients with Follow up visits intervals\> 1 month (+/- 1 week)
intravitreal inj +induction+ month. FU	intravitreal injections of Lucentis	Group of patients who received Lucentis with induction phase and who were monthly monitored (+/- 1 week)
date Lucentis® 1st intravitreal Inj.	intravitreal injections of Lucentis	Group of patients selected in accordance with the date of Lucentis® treatment start.

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).	measured at 24 months (± 4 weeks)

Secondary Outcome Measures

Name	Time	Method
the mean change of the BCVA throughout the 24 months of follow-up (FU),	24 months of follow-up

Trial Locations

Locations (1)

Hopital Saint Joseph; 🇫🇷 Marseille, France