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Macugen Observational Study

Last updated on October 8, 2019

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Study Location
Pfizer Investigational Site
Navrangpura, Ahemdabad, Gujarat, 380009 India
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vascular Endothelial Growth Factor, Macular Degeneration
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-90 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
age-related macular degeneration (AMD).

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

- Active or suspected ocular or periocular infection.

- Known hypersensitivity to pegaptanib sodium or any other excipient in this product.

NCT00735943
Pfizer
Terminated
Macugen Observational Study

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Descriptive Information
Brief TitleMacugen Observational Study
Official TitleMacugen Observational Study
Brief SummaryThe objective of this observational study is to evaluate the effectiveness and safety of Macugen for treatment of wet age-related macular degeneration (AMD) in Indian patients.Prospective, Observational, Non-interventional Study. The period of observation for the study will be 1 year
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 age-related macular degeneration (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.

The study was prematurely discontinued due to delay in meeting pre-defined protocol recruitment milestones on August 30, 2010. There were no safety concerns regarding the study in the decision to terminate the trial.

Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationTo 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 age-related macular degeneration (AMD).
Condition
  • Vascular Endothelial Growth Factor
  • Macular Degeneration
InterventionOther: No intervention
No intervention
Study Groups/CohortsNot Provided
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 StatusTerminated
Actual Enrollment
 (submitted: February 25, 2011)
22
Original Estimated Enrollment
 (submitted: August 14, 2008)
100
Actual Study Completion DateAugust 2010
Actual Primary Completion DateAugust 2010   (Final data collection date for primary outcome measure)
Eligibility 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 age-related macular degeneration (AMD).

Exclusion Criteria:

  • Active or suspected ocular or periocular infection.
  • Known hypersensitivity to pegaptanib sodium or any other excipient in this product.
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesIndia
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00735943
Other Study ID NumbersA5751031
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2011

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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