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Efficacy, Safety, Tolerability of Pegaptanib Sodium (Macugen) in Filipino Patients With Neovascular Age Related Macular Degeneration.

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NCT00820742

Last updated on March 27, 2020
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Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neovascular Age-related Macular Degeneration
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Must have at least one eye which was diagnosed with neovascular degeneration

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Presence of other causes of choroidal neovascularization, including pathologic myopia
(spherical equivalent of -8 diopters or more negative, or axial length of 25mm or
more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, multifocal
choroiditis

NCT00820742
Pfizer
Withdrawn
Efficacy, Safety, Tolerability of Pegaptanib Sodium (Macugen) in Filipino Patients With Neovascular Age Related Macular Degeneration.

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[email protected]

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Descriptive Information
Brief Title Efficacy, Safety, Tolerability of Pegaptanib Sodium (Macugen) in Filipino Patients With Neovascular Age Related Macular Degeneration.
Official Title The Efficacy, Safety, and Tolerability of Pegaptanib Sodium in Filipino Patients With Neovascular Age-related Macular Degeneration: A Post Marketing Surveillance Study.
Brief Summary An open label, non-comparative, multicenter, non-interventional, post marketing surveillance study to evaluate the overall safety and tolerability of pegaptanib sodium(Macugen) in the treatment of Filipino patients with neovascular age-related macular degeneration based on incidence of adverse events and to evaluate the efficacy based on visual acuity, and the patient's and physician's overall satisfaction with tolerability and efficacy.
Detailed Description Open-label, non-comparative, non-interventional study
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Male of female 50 years and older, diagnosed with age-related macular degeneration
Condition Neovascular Age-related Macular Degeneration
Intervention Drug: Macugen
Intravitreous injection of Pegaptanib Sodium 3.47 mg/mL solution every 6 weeks
Study Groups/Cohorts Phase IV Post Marketing Surveillance Study
Open-label, observational study
Intervention: Drug: Macugen
Publications * Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: March 4, 2015) 		0
Original Estimated Enrollment
 (submitted: January 9, 2009) 		100
Estimated Study Completion Date May 2009
Estimated Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Must have at least one eye which was diagnosed with neovascular degeneration

Exclusion Criteria:

  • Presence of other causes of choroidal neovascularization, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, multifocal choroiditis
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00820742
Other Study ID Numbers A5751025
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2015

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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