NCT02089503
Unknown
N/A
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.
Hospital St. Joseph, Marseille, France1 site in 1 country250 target enrollmentMarch 2014
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Exudative Age-Related Macular Degeneration
- Sponsor
- Hospital St. Joseph, Marseille, France
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).
- Last Updated
- 12 years ago
Overview
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).
Investigators
QUEGUINER, MD
Ophtalmologist
Hospital St. Joseph, Marseille, France
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
- •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;
Outcomes
Primary Outcomes
Best Corrected Visual Acuity (BCVA), measured at 24 months (± 4 weeks).
Time Frame: measured at 24 months (± 4 weeks)
Secondary Outcomes
- the mean change of the BCVA throughout the 24 months of follow-up (FU),(24 months of follow-up)
Study Sites (1)
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