check_circleStudy Completed

Macular Degeneration

Bayer Identifier:

16378

ClinicalTrials.gov Identifier:

NCT01933152

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

Both

Age

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

Trial summary

Enrollment Goal
137
Trial Dates
August 2012 - April 2013
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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 chard
    date_rangeTime Frame:
    Baseline and 24 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Demographic characteristics of patients included in the study (Age, Sex, Race)
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Mean time from first clinical presentation to diagnosis
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Mean time from diagnosis to treatment
    date_rangeTime Frame:
    Time from diagnosis to treatment: Up to 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean time from diagnosis to end of follow-up
    date_rangeTime Frame:
    Time from diagnosis to end of follow-up: up to 48 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean change of visual acuity, from diagnosis to end of follow-up, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or Snellen chart
    date_rangeTime Frame:
    Baseline and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean change of retinal thickness from diagnosis to end of follow-up, assessed by Optical Coherence Tomography (OCT)
    date_rangeTime Frame:
    Baseline and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Mean change of lesion size from diagnosis to end of follow-up, assessed by Fluorescein Angiography (FA)
    date_rangeTime Frame:
    Baseline and 24 months
    enhanced_encryption
    Safety Issue:
    No
  • Average number of treatments given from diagnosis to end of follow-up
    date_rangeTime Frame:
    After 24 months
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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