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

Last updated on November 20, 2019

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Study Location
Contact
1-800-718-1021
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Withdrawn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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Descriptive Information
Brief TitleEfficacy, Safety, Tolerability of Pegaptanib Sodium (Macugen) in Filipino Patients With Neovascular Age Related Macular Degeneration.
Official TitleThe Efficacy, Safety, and Tolerability of Pegaptanib Sodium in Filipino Patients With Neovascular Age-related Macular Degeneration: A Post Marketing Surveillance Study.
Brief SummaryAn 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 DescriptionOpen-label, non-comparative, non-interventional study
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationMale of female 50 years and older, diagnosed with age-related macular degeneration
ConditionNeovascular Age-related Macular Degeneration
InterventionDrug: Macugen
Intravitreous injection of Pegaptanib Sodium 3.47 mg/mL solution every 6 weeks
Study Groups/CohortsPhase 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 StatusWithdrawn
Actual Enrollment
 (submitted: March 4, 2015)
0
Original Estimated Enrollment
 (submitted: January 9, 2009)
100
Estimated Study Completion DateMay 2009
Estimated Primary Completion DateMay 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
Ages50 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00820742
Other Study ID NumbersA5751025
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2015

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

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