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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

No comparator Patients with age-related macular degeneration

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 13, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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