Monocentric Retrospective Observational Study on Patients With Macular Degeneration

NCT02089503 | Unknown DMC

• 1 other identifier: ELOUAN HSJ 2014
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  measured at 24 months (± 4 weeks)

Secondary Outcomes (1)

• the mean change of the BCVA throughout the 24 months of follow-up (FU),

  24 months of follow-up

Study Arms (6)

induction phase + intravitreal inj.

Group of patients who received Lucentis ® with induction phase

Other: intravitreal injections of Lucentis

intravitreal inj. without induction

Group of patients who received Lucentis ® without induction phase

Other: intravitreal injections of Lucentis

intravitreal inj. + monthly follow-up

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

Other: intravitreal injections of Lucentis

intravitreal inj. + follow-up :> 1 month

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

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)

Other: intravitreal injections of Lucentis

date Lucentis® 1st intravitreal Inj.

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

Other: intravitreal injections of Lucentis

Interventions

intravitreal injections of Lucentis OTHER

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

date Lucentis® 1st intravitreal Inj.; induction phase + intravitreal inj.; intravitreal inj +induction+ month. FU; intravitreal inj. + follow-up :> 1 month; intravitreal inj. + monthly follow-up; intravitreal inj. without induction

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with exudative Age-Related Macular Degeneration (ARMD), treated with Lucentis, under real conditions of care

You may qualify if:

• 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;

You may not qualify if:

• \- 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;
• \- Patients with high myopia or neovessel not related to exudative-ARMD;

Sponsors & Collaborators

• Hospital St. Joseph, Marseille, France: lead

Study Sites (1)

Hopital Saint Joseph

Marseille, 13008, France

Location

Study Officials

• Maud RIGHINI, MD

  HSJ

  STUDY CHAIR

Central Study Contacts

Frederic QUEGUINER, MD

CONTACT

+33491806793; fqueguiner@hopital-saint-joseph.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophtalmologist

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 17, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 18, 2014

Record last verified: 2014-03

Locations

FR (1)