Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration

November 14, 2012 updated by: Pfizer

European Epidemiologic COHORT Study: A Prospective Epidemiologic COHORT Study Of Ocular Safety In Patients Receiving Macugen Injections For Neovascular Age-Related Macular Degeneration (AMD) In Europe

The study will provide additional safety data for specific safety events in persons receiving intravitreal injections. The Committee for Medicinal Products for Human Use (CHMP) is interested in obtaining additional safety information when Macugen is used in real world settings by practitioners in Europe treating patients with neovascular (wet) age-related macular degeneration (AMD). The study will provide information about physician practice patterns and characteristics of patients treated with Macugen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

No comparator Patients with age-related macular degeneration

Study Type

Observational

Enrollment (Actual)

501

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Pfizer Investigational Site
      • Charleroi, Belgium, 6000
        • Pfizer Investigational Site
      • Ieper, Belgium, 8900
        • Pfizer Investigational Site
      • Lier, Belgium, 2500
        • Pfizer Investigational Site
      • Turnhout, Belgium, 2300
        • Pfizer Investigational Site
  • Cyprus
      • Lemesos, Cyprus, 1430
        • Pfizer Investigational Site
  • Czech Republic
      • Brno, Czech Republic, 625 00
        • Pfizer Investigational Site
      • Hradec Kralove, Czech Republic, 500 05
        • Pfizer Investigational Site
      • Plzen, Czech Republic, 304 60
        • Pfizer Investigational Site
      • Praha 10, Czech Republic, 10034
        • Pfizer Investigational Site
      • Praha 2, Czech Republic, 128 08
        • Pfizer Investigational Site
      • Praha 6, Czech Republic, 169 02
        • Pfizer Investigational Site
  • Denmark
      • Soenderborg, Denmark, 6400
        • Pfizer Investigational Site
  • France
      • Argonay, France, 74370
        • Pfizer Investigational Site
      • Dijon, France, 21055
        • Pfizer Investigational Site
      • Grenoble, France, 38100
        • Pfizer Investigational Site
      • Le Golfe Juan, France, 06220
        • Pfizer Investigational Site
      • Marseille cedex 08, France, 13285
        • Pfizer Investigational Site
      • Rennes, France, 35033
        • Pfizer Investigational Site
  • Germany
      • Augsburg, Germany, 86156
        • Pfizer Investigational Site
      • Frankfurt, Germany, 60318
        • Pfizer Investigational Site
      • Karlsruhe, Germany, 76137
        • Pfizer Investigational Site
      • Konstanz, Germany, 78462
        • Pfizer Investigational Site
      • Ludwigshafen, Germany, 67063
        • Pfizer Investigational Site
      • Muenchen, Germany, 81675
        • Pfizer Investigational Site
      • Muenster, Germany, 48145
        • Pfizer Investigational Site
      • Weilheim, Germany, 82362
        • Pfizer Investigational Site
  • Greece
      • Athens, Greece, 11526
        • Pfizer Investigational Site
      • Athens, Greece, 115 27
        • Pfizer Investigational Site
      • Athens, Greece, 10672
        • Pfizer Investigational Site
      • Heraklion, Greece, 71001
        • Pfizer Investigational Site
      • Ioannina, Greece, 45500
        • Pfizer Investigational Site
      • Kavala, Greece
        • Pfizer Investigational Site
      • Thessaloniki, Greece, 54636
        • Pfizer Investigational Site
      • Thessaloniki, Greece, 54642
        • Pfizer Investigational Site
    • Crete
      • Heraklion, Crete, Greece, 71110
        • Pfizer Investigational Site
    • Piraeus
      • Nikea, Piraeus, Greece, 18454
        • Pfizer Investigational Site
  • Ireland
      • Waterford, Ireland
        • Pfizer Investigational Site
  • Italy
      • Arona, NO, Italy, 28041
        • Pfizer Investigational Site
      • Bologna, Italy, 40138
        • Pfizer Investigational Site
      • Cagliari, Italy, 09100
        • Pfizer Investigational Site
      • Monza, MI, Italy, 20052
        • Pfizer Investigational Site
      • Napoli, Italy, 80131
        • Pfizer Investigational Site
      • Pisa, Italy, 56124
        • Pfizer Investigational Site
      • Rieti, Italy, 02100
        • Pfizer Investigational Site
      • Siena, Italy, 53100
        • Pfizer Investigational Site
  • Poland
      • Bydgoszcz, Poland, 85 - 094
        • Pfizer Investigational Site
      • Szczecin, Poland, 70 - 111
        • Pfizer Investigational Site
      • Warszawa, Poland, 04-141
        • Pfizer Investigational Site
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 826 06
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 851 03
        • Pfizer Investigational Site
      • Kosice, Slovakia, 041 66
        • Pfizer Investigational Site
      • Presov, Slovakia, 08001
        • Pfizer Investigational Site
      • Presov, Slovakia, 081 81
        • Pfizer Investigational Site
      • Ruzomberok, Slovakia, 03426
        • Pfizer Investigational Site
      • Trencin, Slovakia, 911 71
        • Pfizer Investigational Site
      • Zilina, Slovakia, 012 07
        • Pfizer Investigational Site
  • Spain
      • Madrid, Spain, 28040
        • Pfizer Investigational Site
      • Santa Cruz de Tenerife, Spain, 38010
        • Pfizer Investigational Site
      • Valencia, Spain, 46014
        • Pfizer Investigational Site
      • Valencia, Spain, 46015
        • Pfizer Investigational Site
      • Valladolid, Spain, 47010
        • Pfizer Investigational Site
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
        • Pfizer Investigational Site
    • Madrid
      • Alcala de Henares, Madrid, Spain, 28805
        • Pfizer Investigational Site
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Pfizer Investigational Site
  • Sweden
      • Stockholm, Sweden, 118 83
        • Pfizer Investigational Site
      • Västerås, Sweden, 721 89
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with age-related macular degeneration

Description

Inclusion Criteria:

  • Neovascular AMD patients who are eligible for Macugen therapy based on the approved label

Exclusion Criteria:

  • Active or suspected ocular or periocular infection. Known hypersensitivity to the active substance or any of its excipients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational study, no comparator
Observational study of patients with AMD treated with Macugen, no comparator
Drug: Macugen
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection
Time Frame: Baseline up to 2 years
POAEs: primarily endophthalmitis, as well as increased intraocular pressure (IOP), vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection equals (=) number of specific POAEs divided by the total number of injections received.
Baseline up to 2 years
Incidence of POAEs Per Injection Reported by Gender (Females)
Time Frame: Baseline up to 2 years
POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.
Baseline up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of POAEs Per Injection Reported by Gender (Males)
Time Frame: Baseline up to 2 years
POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.
Baseline up to 2 years
Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years)
Time Frame: Baseline up to 2 years
POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.
Baseline up to 2 years
Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years)
Time Frame: Baseline up to 2 years
POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.
Baseline up to 2 years
Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years)
Time Frame: Baseline up to 2 years
POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.
Baseline up to 2 years
Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years)
Time Frame: Baseline up to 2 years
POAEs: primarily endophthalmitis, as well as increased IOP, vitreous hemorrhage, traumatic cataract, retinal detachment, and retinal tear. Incidence of POAEs per injection = number of specific POAEs divided by the total number of injections received.
Baseline up to 2 years
Number of Participants With Serious Hypersensitivity Reactions
Time Frame: Baseline up to 2 years
Hypersensitivity reactions include Hypersensitivity, Drug hypersensitivity, Anaphylactic shock, Anaphylactic reaction, Anaphylactoid shock, Angioedema Anaphylactoid reaction, Blepharitis allergic, Dermatitis contact, Dermatitis allergic, Toxic skin eruption, Toxic epidermal necrolysis, Drug eruption, Erythema, Erythema multiforme, Tongue oedema, Pharyngeal oedema, Laryngeal oedema, Latex allergy, Paraesthesia oral, Paraesthesia mucosal, Urticaria, Stevens-Johnson syndrome, Rash, Skin reaction, Acute generalised exanthematous pustulosis, Drug rash with eosinphilia and systemic symptoms.
Baseline up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

April 13, 2007

First Submitted That Met QC Criteria

April 13, 2007

First Posted (Estimate)

April 16, 2007

Study Record Updates

Last Update Posted (Estimate)

December 11, 2012

Last Update Submitted That Met QC Criteria

November 14, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5751019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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