Clinical trial NCT01933152: Study to Assess the EffectiVeness of exIsting Anti-vascular Endothelial groWth Factor (Anti-VEGF) Treatment Regimens in Patients With Wet Age-related Macular Degeneration
Official title: Review Study: A Retrospective Noninterventional Study to Assess the EffectiVeness of exIsting Anti-vascular Endothelial groWth Factor (Anti-VEGF) Treatment Regimens in Patients With Wet Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration
Keywords: wAMD
anti-VEGF
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-09-02
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients must have been diagnosed to suffer from wet AMD and must have started anti-VEGF treatment with ranibizumab between January 1, 2009, and December 31, 2009

Brief summary: Retrospective, non-interventional, observational multi-center field study. Patients diagnosed with wet Age-related macular degeneration (wAMD) and having started treatment with ranibizumab between January 1, 2009 and December 31, 2009 must be consecutively screened and, if eligible, enrolled. Patients will be followed up at maximum until December 31, 2011. Switch to any other Anti vascular endothelial growth factor (anti VEGF) treatment will be documented. For each patient, demographics, medical history, administered treatments, results of ocular and visual assessments and other tests (where available) will be documented.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of wet Age-related Macular Degeneration
* Start of anti-VEGF therapy with ranibizumab (Lucentis) between January 1, 2009 and December 31, 2009
* Informed consent form signed

Exclusion Criteria:

- Participation in an investigational study during anti-VEGF therapy (from start up to December 31, 2011) that involved treatment with any drug or device

Primary outcomes:
measure: Changes in visual acuity after start of Anti vascular endothelial growth factor (anti VEGF) therapy with ranibizumab, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or Snellen chard
timeFrame: Baseline and 24 months
Secondary outcomes:
measure: Demographic characteristics of patients included in the study (Age, Sex, Race)
timeFrame: Baseline
measure: Mean time from first clinical presentation to diagnosis
timeFrame: Baseline
measure: Mean time from diagnosis to treatment
timeFrame: Time from diagnosis to treatment: Up to 24 months
measure: Mean time from diagnosis to end of follow-up
timeFrame: Time from diagnosis to end of follow-up: up to 48 months
measure: Mean change of visual acuity, from diagnosis to end of follow-up, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or Snellen chart
timeFrame: Baseline and 24 months
measure: Mean change of retinal thickness from diagnosis to end of follow-up, assessed by Optical Coherence Tomography (OCT)
timeFrame: Baseline and 24 months
measure: Mean change of lesion size from diagnosis to end of follow-up, assessed by Fluorescein Angiography (FA)
timeFrame: Baseline and 24 months
measure: Average number of treatments given from diagnosis to end of follow-up
timeFrame: After 24 months
Other outcomes:
Locations:
city: Many Locations
country: Portugal
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: