Ocular Safety Of Patients Receiving Macugen For Neovascular Age Related Macular Degeneration - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00460408

Purpose

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.

Condition	Intervention	Phase
Macular Degeneration	Drug: Macugen	Phase IV

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Pegaptanib sodium

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Incidence of ocular adverse events [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Identification of risk factors for ocular adverse events [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
Collect information on serious hypersensitivity reactions [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	550
Study Start Date:	August 2006
Estimated Study Completion Date:	February 2012

Groups/Cohorts	Assigned Interventions
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.

Detailed Description:

No comparator

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with age-related macular degeneration

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460408

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 55 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5751019
Study First Received:	April 13, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00460408
Health Authority:	United States: Institutional Review Board

Keywords provided by Pfizer:

Macular degeneration, safety, non-interventional, non-randomized

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 16, 2009