Study to Assess the EffectiVeness of exIsting Anti-vascular Endothelial groWth Factor (Anti-VEGF) Treatment Regimens in Patients With Wet Age-related Macular Degeneration

Macular Degeneration Clinical Trial

— REVIEW  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933152
• Other study ID #: 16378
• Status: Completed
• Phase: N/A
• First received: July 29, 2013
• Last updated: September 30, 2014
• Start date: August 2012
• Est. completion date: April 2013

Study information

• Verified date: September 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• Ranibizumab
Patients with wet AMD treated with ranibizumab as prescribed by physician

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Portugal, 

Outcome

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

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