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Macugen Observational Study
This study is currently recruiting participants.
Verified by Pfizer, January 2009
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00735943
  Purpose

The objective of this observational study is to evaluate the effectiveness and safety of Macugen for treatment of wet AMD in Indian patients.Prospective, Observational, Non-interventional Study. The period of observation for the study will be 1 year


Condition
VEGF
Macular Degeneration

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: Macugen Observational Study

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • - Proportion of patients receiving Macugen monotherapy versus those receiving a combination therapy [ Time Frame: one year ] [ Designated as safety issue: No ]
  • - Proportion of patients showing stabilization of visual acuity at last follow up [ Time Frame: one year ] [ Designated as safety issue: No ]
  • - Proportion of patients with improvement in visual acuity at last follow up [ Time Frame: one year ] [ Designated as safety issue: No ]
  • - Proportion of patients with early lesions showing improvement in visual acuity at last follow up [ Time Frame: one year ] [ Designated as safety issue: No ]
  • - Average number of injections to achieve improvement in the group showing improvement in visual acuity at last follow up [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - Average number of injections to achieve stabilization in the group showing stabilization of visual acuity at last follow up [ Time Frame: one year ] [ Designated as safety issue: No ]
  • - Proportion of patients showing improvement Fundus Fluorescein Angiography (FFA) parameters at last follow up [ Time Frame: one year ] [ Designated as safety issue: No ]
  • - Average number of injections to achieve improvement of visual acuity in patients with early lesions, in the group showing improvement, at last followup [ Time Frame: one year ] [ Designated as safety issue: No ]
  • - In the subgroup previously treated by other therapy, proportion of patients showing improvement in visual acuity [ Time Frame: one year ] [ Designated as safety issue: No ]
  • - Proportion of patients experiencing adverse events, ocular and non-ocular [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 100
Study Start Date: October 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Detailed Description:

To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet AMD. The decision to prescribe Macugen will necessarily precede and will be independent of the decision to enroll patient into the study.

If both eyes of a patient receive injection Macugen, only one eye will be included in the study. If both eyes receive first injection Macugen after initiation of the study, only the first treated eye will be included in the analysis. If one eye has already received Macugen when the study starts and the second eye receives injection after the study initiation, the second eye will be included in the analysis.

  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

To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet AMD.

Criteria

Inclusion Criteria:

  • To be eligible for enrollment in this study, patients must receive the first injection of Macugen intravitreal in at least one eye for treatment of wet AMD.

Exclusion Criteria:

  • Active or suspected ocular or periocular infection.
  • Known hypersensitivity to pegaptanib sodium or any other excipient in this product.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735943

Contacts
Contact: Sonali Dighe +91 93221 62757 sonali.dighe@pfizer.com
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
India, Kerala
Pfizer Investigational Site Recruiting
Cochin, Kerala, India, 682 015
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: A5751031
Study First Received: August 14, 2008
Last Updated: January 14, 2009
ClinicalTrials.gov Identifier: NCT00735943  
Health Authority: Unknown:

Keywords provided by Pfizer:
Pegaptanib, Macular degeneration, VEGF

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