Long-Term Non-Interventional Study (NIS) to Investigate the Safety and Effectiveness of MACUGEN in Patients With Neovascular Age-Related Macular Degeneration Under Conditions of Routine Clinical Practice - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00787319

Purpose

To define what procedures were used for the diagnosis and monitoring of the treatment AMD. What is the effect of the Macugen, compliance with Macugen treatment, safety profile of Macugen, final physician assessment of treatment with Macugen.

Condition	Intervention	Phase
AMD	Other: no intervention	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:	Case Control, Cross-Sectional
Official Title:	Long-Term Non-Interventional Study (NIS) to Investigate the Safety and Effectiveness of MACUGEN in Patients With Neovascular Age-Related Macular Degeneration Under Conditions of Routine Clinical Practice

Further study details as provided by Pfizer:

Primary Outcome Measures:

Which procedures are used for diagnosis of the neovascular AMD? [ Time Frame: duration of study ] [ Designated as safety issue: No ]
what procedures are used for monitoring the course of treatment? [ Time Frame: duration of study ] [ Designated as safety issue: No ]
Efficacy of Macugen [ Time Frame: duration of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compliance with Macugen treatment. [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
Safety profile of Macugen in routine clinical practice. [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]
Final Physician assessment of treatment with Macugen for effectiveness and tolerability evaluated on point scale. [ Time Frame: duration of study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	120
Study Start Date:	November 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
AMD outpatients with AMD	Other: no intervention There is no intervention in this study. It is observational only.

Detailed Description:

no sampling

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

outpatients

Criteria

Inclusion Criteria:

age over 18 years old ,
patients with neovascular age-related macular degeneration.
enrollment to study is fully on physician decision in compliance with current SPC

Exclusion Criteria:

Patient who did not meet indication according to SPC Macugen.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787319

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

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:	A5751032
Study First Received:	November 6, 2008
Last Updated:	November 6, 2008
ClinicalTrials.gov Identifier:	NCT00787319
Health Authority:	Czech Republic: State Institute for Drug Control

Keywords provided by Pfizer:

Ophthalmology, AMD, outpatients

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