Clinical trial NCT00460408: Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration
Keywords: Macular degeneration
Safety
Non-interventional
Non-randomized
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-04-16
Enrollment: 501
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with age-related macular degeneration

Brief summary: 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.

Detailed description: No comparator Patients with age-related macular degeneration

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection
timeFrame: Baseline up to 2 years
measure: Incidence of POAEs Per Injection Reported by Gender (Females)
timeFrame: Baseline up to 2 years
Secondary outcomes:
measure: Incidence of POAEs Per Injection Reported by Gender (Males)
timeFrame: Baseline up to 2 years
measure: Incidence of POAEs Per Injection Reported by Age Group (≤ 50 Years)
timeFrame: Baseline up to 2 years
measure: Incidence of POAEs Per Injection Reported by Age Group (51 to 64 Years)
timeFrame: Baseline up to 2 years
measure: Incidence of POAEs Per Injection Reported by Age Group (65 to 74 Years)
timeFrame: Baseline up to 2 years
measure: Incidence of POAEs Per Injection Reported by Age Group (≥ 75 Years)
timeFrame: Baseline up to 2 years
measure: Number of Participants With Serious Hypersensitivity Reactions
timeFrame: Baseline up to 2 years
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Charleroi
country: Belgium
facility: Pfizer Investigational Site
city: Ieper
country: Belgium
facility: Pfizer Investigational Site
city: Lier
country: Belgium
facility: Pfizer Investigational Site
city: Turnhout
country: Belgium
facility: Pfizer Investigational Site
city: Lemesos
country: Cyprus
facility: Pfizer Investigational Site
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: Pfizer Investigational Site
city: Plzen
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 10
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 2
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 6
country: Czech Republic
facility: Pfizer Investigational Site
city: Soenderborg
country: Denmark
facility: Pfizer Investigational Site
city: Argonay
country: France
facility: Pfizer Investigational Site
city: Dijon
country: France
facility: Pfizer Investigational Site
city: Grenoble
country: France
facility: Pfizer Investigational Site
city: Le Golfe Juan
country: France
facility: Pfizer Investigational Site
city: Marseille cedex 08
country: France
facility: Pfizer Investigational Site
city: Rennes
country: France
facility: Pfizer Investigational Site
city: Augsburg
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt
country: Germany
facility: Pfizer Investigational Site
city: Karlsruhe
country: Germany
facility: Pfizer Investigational Site
city: Konstanz
country: Germany
facility: Pfizer Investigational Site
city: Ludwigshafen
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Weilheim
country: Germany
facility: Pfizer Investigational Site
city: Heraklion
country: Greece
facility: Pfizer Investigational Site
state: Crete
city: Nikea
country: Greece
facility: Pfizer Investigational Site
state: Piraeus
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Heraklion
country: Greece
facility: Pfizer Investigational Site
city: Ioannina
country: Greece
facility: Pfizer Investigational Site
city: Kavala
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Waterford
country: Ireland
facility: Pfizer Investigational Site
city: Arona, NO
country: Italy
facility: Pfizer Investigational Site
city: Bologna
country: Italy
facility: Pfizer Investigational Site
city: Cagliari
country: Italy
facility: Pfizer Investigational Site
city: Monza, MI
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Pisa
country: Italy
facility: Pfizer Investigational Site
city: Rieti
country: Italy
facility: Pfizer Investigational Site
city: Siena
country: Italy
facility: Pfizer Investigational Site
city: Bydgoszcz
country: Poland
facility: Pfizer Investigational Site
city: Szczecin
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Banska Bystrica
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Presov
country: Slovakia
facility: Pfizer Investigational Site
city: Presov
country: Slovakia
facility: Pfizer Investigational Site
city: Ruzomberok
country: Slovakia
facility: Pfizer Investigational Site
city: Trencin
country: Slovakia
facility: Pfizer Investigational Site
city: Zilina
country: Slovakia
facility: Pfizer Investigational Site
city: Santiago de Compostela
country: Spain
facility: Pfizer Investigational Site
state: A Coruña
city: Alcala de Henares
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Pamplona
country: Spain
facility: Pfizer Investigational Site
state: Navarra
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Santa Cruz de Tenerife
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Valladolid
country: Spain
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Västerås
country: Sweden
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: