Efficacy and Safety of Macugen (Pegaptanib Sodium) in Patients With Neovascular AMD in Routine Clinical Practice. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00858208

Purpose

Efficacy and safety of MACUGEN (pegaptanib sodium) in patients suffering from neovascular age-related macular degeneration in routine clinical practice at least as good as demonstrated in randomized multicenter clinical trials.

Condition	Intervention	Phase
Neovascular Age-Related Macular Degeneration	Drug: Macugen(pegaptanib sodium)	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-Only, Prospective
Official Title:	Long-Term Non-Interventional Study To Investigate The Efficacy And Safety 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:

The effect of Macugen(pegaptanib sodium) treatment on patient Visual Acuity [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Safety profile of Macugen(pegaptanib sodium) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Procedures used for AMD diagnosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Procedures for monitoring the course of treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Treatment efficacy in patients with REPD [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Patient population that benefit more from treatment with Macugen(pegaptanib sodium) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Persistency and compliance with Macugen(pegaptanib sodium) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Effect of Macugen(pegaptanib sodium) in patient quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Effect of Macugen(pegaptanib sodium) on Intraocular pressure [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	March 2008
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients with neovascular Age-Related Macula Degeneration	Drug: Macugen(pegaptanib sodium) Macugen(pegaptanib sodium) intravitreal injection every 6 weeks for 2 years, as a part of routine clinical practice.

Detailed Description:

Eligible patients in routine clinical practice

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with Age-related Macula degeneration

Criteria

Inclusion Criteria:

Adults with neovascular age-related macula degeneration

Exclusion Criteria:

According to SmPC

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858208

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

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

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5751028
Study First Received:	February 26, 2009
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00858208 History of Changes
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Pfizer:

Macugen(pegaptanib sodium)

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

Additional relevant MeSH terms:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on May 06, 2009