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

NCT ID: NCT00460408

Last Updated: 2012-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

501 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

Study Completion Date

2012-02-29

Brief Summary

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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

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No comparator Patients with age-related macular degeneration

Conditions

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Macular Degeneration

Keywords

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Macular degeneration Safety Non-interventional Non-randomized

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Observational study, no comparator

Observational study of patients with AMD treated with Macugen, no comparator

Macugen

Intervention Type DRUG

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

Interventions

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Macugen

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brussels, , Belgium

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Charleroi, , Belgium

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Ieper, , Belgium

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Lier, , Belgium

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Turnhout, , Belgium

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Limassol, , Cyprus

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Brno, , Czechia

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Hradec Králové, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Sønderborg, , Denmark

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Argonay, , France

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Dijon, , France

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Grenoble, , France

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Le Golfe Juan, , France

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Marseille, , France

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Rennes, , France

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Augsburg, , Germany

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Frankfurt, , Germany

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Karlsruhe, , Germany

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Konstanz, , Germany

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Ludwigshafen, , Germany

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München, , Germany

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Münster, , Germany

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Weilheim, , Germany

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Heraklion, Crete, Greece

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Nikaia, Piraeus, Greece

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Athens, , Greece

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Athens, , Greece

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Athens, , Greece

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Heraklion, , Greece

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Ioannina, , Greece

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Kavala, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Waterford, , Ireland

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Arona, NO, , Italy

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Bologna, , Italy

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Cagliari, , Italy

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Monza, MI, , Italy

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Napoli, , Italy

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Pisa, , Italy

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Rieti, , Italy

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Siena, , Italy

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Bydgoszcz, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Banská Bystrica, , Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Košice, , Slovakia

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Prešov, , Slovakia

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Prešov, , Slovakia

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Ružomberok, , Slovakia

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Trenčín, , Slovakia

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Žilina, , Slovakia

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Santiago de Compostela, A Coruña, Spain

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Alcalá de Henares, Madrid, Spain

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Madrid, Madrid, Spain

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Pamplona, Navarre, Spain

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Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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Valladolid, Valladolid, Spain

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Stockholm, , Sweden

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Västerås, , Sweden

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Countries

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Belgium Cyprus Czechia Denmark France Germany Greece Ireland Italy Poland Slovakia Spain Sweden

Related Links

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Other Identifiers

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A5751019

Identifier Type: -

Identifier Source: org_study_id