NCT01447043

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 August 31, 2009 must be consecutively screened and, if eligible, enrolled. Patients will be followed up at maximum until August 31, 2011. Switch to any other Anti vascUlar endothelial growth factor (anti VEGF) treatment will be documented and followed up. For each patient, demographics, medical history, administered treatments, results of ocular and visual assessments and other tests (where available) will be documented.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,609

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
10 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 5, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

January 27, 2014

Status Verified

January 1, 2014

Enrollment Period

2.6 years

First QC Date

September 20, 2011

Last Update Submit

January 24, 2014

Conditions

Ophthalmology, Macular Degeneration

Keywords

retrospective studies

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (10)

  • Demographic characteristics of patients included in the study (Age, Sex, Race)

    Baseline

  • Mean time from first clinical presentation to diagnosis

    Time from first clinical presentation to diagnosis: Up to 36 months

  • Mean time from diagnosis to treatment

    Time from diagnosis to treatment: Up to 24 months

  • Mean time from diagnosis to end of follow-up

    Time from diagnosis to end of follow-up: 48 months

  • Mean change of visual acuity, from diagnosis to end of follow-up, assessed by Early Treatment Diabetic Retinopathy (ETDRS) or SNELLEN

    Baseline and 24 months

  • +5 more secondary outcomes

Study Arms (1)

Group 1

Drug: Ranibizumab

Interventions

RanibizumabDRUG

Patients with wet AMD treated with ranibizumab as prescribed by physician

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 August 31, 2009.

You may qualify if:

  • Diagnosis of wet age-related macular degeneration
  • Start of Anti vascUlar endothelial growth factor (anti VEGF) therapy with ranibizumab between January 1, 2009 and August 31, 2009
  • Informed consent form signed, where required

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Many Locations, Australia

Location

Unknown Facility

Many Locations, Canada

Location

Unknown Facility

Many Locations, France

Location

Unknown Facility

Many Locations, Germany

Location

Unknown Facility

Many Locations, Ireland

Location

Unknown Facility

Many Locations, Italy

Location

Unknown Facility

Many Locations, Japan

Location

Unknown Facility

Many Locations, Netherlands

Location

Unknown Facility

Many Locations, United Kingdom

Location

Unknown Facility

Many Locations, Venezuela

Location

Related Publications (2)

  • Holz FG, Tadayoni R, Beatty S, Berger A, Cereda MG, Hykin P, Staurenghi G, Wittrup-Jensen K, Altemark A, Nilsson J, Kim K, Sivaprasad S. Key drivers of visual acuity gains in neovascular age-related macular degeneration in real life: findings from the AURA study. Br J Ophthalmol. 2016 Dec;100(12):1623-1628. doi: 10.1136/bjophthalmol-2015-308166. Epub 2016 Mar 30.

    PMID: 27030279DERIVED

  • Holz FG, Tadayoni R, Beatty S, Berger A, Cereda MG, Cortez R, Hoyng CB, Hykin P, Staurenghi G, Heldner S, Bogumil T, Heah T, Sivaprasad S. Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. Br J Ophthalmol. 2015 Feb;99(2):220-6. doi: 10.1136/bjophthalmol-2014-305327. Epub 2014 Sep 5.

    PMID: 25193672DERIVED

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2011

First Posted

October 5, 2011

Study Start

January 1, 2009

Primary Completion

August 1, 2011

Study Completion

November 1, 2012

Last Updated

January 27, 2014

Record last verified: 2014-01

Locations

DE(1)IT(1)AU(1)VE(1)CA(1)FR(1)IE(1)JP(1)NL(1)GB(1)