check_circleStudy Completed
Macular Degeneration
Bayer Identifier:
16378
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study to assess the EffectiVeness of exIsting anti-vascular Endothelial groWth factor (anti-VEGF) treatment regimens in patients with wet age-related macular degeneration
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
137Trial Dates
August 2012 - April 2013Phase
N/ACould I Receive a placebo
NoProducts
No DrugAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Portugal |
Primary Outcome
- 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 charddate_rangeTime Frame:Baseline and 24 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Demographic characteristics of patients included in the study (Age, Sex, Race)date_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
- Mean time from first clinical presentation to diagnosisdate_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
- Mean time from diagnosis to treatmentdate_rangeTime Frame:Time from diagnosis to treatment: Up to 24 monthsenhanced_encryptionNoSafety Issue:
- Mean time from diagnosis to end of follow-update_rangeTime Frame:Time from diagnosis to end of follow-up: up to 48 monthsenhanced_encryptionNoSafety Issue:
- Mean change of visual acuity, from diagnosis to end of follow-up, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or Snellen chartdate_rangeTime Frame:Baseline and 24 monthsenhanced_encryptionNoSafety Issue:
- Mean change of retinal thickness from diagnosis to end of follow-up, assessed by Optical Coherence Tomography (OCT)date_rangeTime Frame:Baseline and 24 monthsenhanced_encryptionNoSafety Issue:
- Mean change of lesion size from diagnosis to end of follow-up, assessed by Fluorescein Angiography (FA)date_rangeTime Frame:Baseline and 24 monthsenhanced_encryptionNoSafety Issue:
- Average number of treatments given from diagnosis to end of follow-update_rangeTime Frame:After 24 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A