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

Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00460408
• Other study ID #: A5751019
• Status: Completed
• Phase: N/A
• First received: April 13, 2007
• Last updated: November 14, 2012
• Start date: August 2006
• Est. completion date: February 2012

Study information

• Verified date: November 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

No comparator Patients with age-related macular degeneration

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Macugen
Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Charleroi
Belgium	Pfizer Investigational Site	Ieper
Belgium	Pfizer Investigational Site	Lier
Belgium	Pfizer Investigational Site	Turnhout
Cyprus	Pfizer Investigational Site	Lemesos
Czech Republic	Pfizer Investigational Site	Brno
Czech Republic	Pfizer Investigational Site	Hradec Kralove
Czech Republic	Pfizer Investigational Site	Plzen
Czech Republic	Pfizer Investigational Site	Praha 10
Czech Republic	Pfizer Investigational Site	Praha 2
Czech Republic	Pfizer Investigational Site	Praha 6
Denmark	Pfizer Investigational Site	Soenderborg
France	Pfizer Investigational Site	Argonay
France	Pfizer Investigational Site	Dijon
France	Pfizer Investigational Site	Grenoble
France	Pfizer Investigational Site	Le Golfe Juan
France	Pfizer Investigational Site	Marseille cedex 08
France	Pfizer Investigational Site	Rennes
Germany	Pfizer Investigational Site	Augsburg
Germany	Pfizer Investigational Site	Frankfurt
Germany	Pfizer Investigational Site	Karlsruhe
Germany	Pfizer Investigational Site	Konstanz
Germany	Pfizer Investigational Site	Ludwigshafen
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Muenster
Germany	Pfizer Investigational Site	Weilheim
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Heraklion
Greece	Pfizer Investigational Site	Heraklion	Crete
Greece	Pfizer Investigational Site	Ioannina
Greece	Pfizer Investigational Site	Kavala
Greece	Pfizer Investigational Site	Nikea	Piraeus
Greece	Pfizer Investigational Site	Thessaloniki
Greece	Pfizer Investigational Site	Thessaloniki
Ireland	Pfizer Investigational Site	Waterford
Italy	Pfizer Investigational Site	Arona, NO
Italy	Pfizer Investigational Site	Bologna
Italy	Pfizer Investigational Site	Cagliari
Italy	Pfizer Investigational Site	Monza, MI
Italy	Pfizer Investigational Site	Napoli
Italy	Pfizer Investigational Site	Pisa
Italy	Pfizer Investigational Site	Rieti
Italy	Pfizer Investigational Site	Siena
Poland	Pfizer Investigational Site	Bydgoszcz
Poland	Pfizer Investigational Site	Szczecin
Poland	Pfizer Investigational Site	Warszawa
Slovakia	Pfizer Investigational Site	Banska Bystrica
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Kosice
Slovakia	Pfizer Investigational Site	Presov
Slovakia	Pfizer Investigational Site	Presov
Slovakia	Pfizer Investigational Site	Ruzomberok
Slovakia	Pfizer Investigational Site	Trencin
Slovakia	Pfizer Investigational Site	Zilina
Spain	Pfizer Investigational Site	Alcala de Henares	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Pamplona	Navarra
Spain	Pfizer Investigational Site	Santa Cruz de Tenerife
Spain	Pfizer Investigational Site	Santiago de Compostela	A Coruña
Spain	Pfizer Investigational Site	Valencia
Spain	Pfizer Investigational Site	Valencia
Spain	Pfizer Investigational Site	Valladolid
Sweden	Pfizer Investigational Site	Stockholm
Sweden	Pfizer Investigational Site	Västerås

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Belgium,  Cyprus,  Czech Republic,  Denmark,  France,  Germany,  Greece,  Ireland,  Italy,  Poland,  Slovakia,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Pertinent Ocular Adverse Events (POAEs) Per Injection	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	Yes
Primary	Incidence of POAEs Per Injection Reported by Gender (Females)	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	Yes
Secondary	Incidence of POAEs Per Injection Reported by Gender (Males)	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	Yes
Secondary	Incidence of POAEs Per Injection Reported by Age Group (= 50 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	Yes
Secondary	Incidence of POAEs Per Injection Reported by Age Group (51 to 64 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	Yes
Secondary	Incidence of POAEs Per Injection Reported by Age Group (65 to 74 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	Yes
Secondary	Incidence of POAEs Per Injection Reported by Age Group (= 75 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	Yes
Secondary	Number of Participants With Serious Hypersensitivity Reactions	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	Yes

External Links

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