Monocentric Retrospective Observational Study on Patients With Macular Degeneration

Exudative Age-Related Macular Degeneration Clinical Trial

— ELOUAN  

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.

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02089503
• Other study ID #: ELOUAN HSJ 2014
• Status: Unknown status
• Phase: N/A
• First received: March 14, 2014
• Last updated: March 17, 2014
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: March 2014
• Source: Hospital St. Joseph, Marseille, France
• Contact: Frederic QUEGUINER, MD
• Phone: +33491806793
• Email: fqueguiner[@]hopital-saint-joseph.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 250
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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;

Related Conditions & MeSH terms

• Exudative Age-Related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

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

Locations

Country	Name	City	State
France	Hopital Saint Joseph	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hospital St. Joseph, Marseille, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).		measured at 24 months (± 4 weeks)
Secondary	the mean change of the BCVA throughout the 24 months of follow-up (FU),		24 months of follow-up