Macugen Observational Study

NCT00735943

Last updated date
Study Location
Pfizer Investigational Site
Navrangpura, Ahemdabad, Gujarat, 380009, India
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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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.

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Vascular Endothelial Growth Factor, Macular DegenerationMacugen Observational Study
NCT00735943
  1. Navrangpura, Ahemdabad, Gujarat
  2. Gurgaon, Haryana
  3. Cochin, Kerala
  4. Mumbai, Maharashtra
  5. Jaipur, Rajasthan
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Macugen Observational Study
Official Title Macugen Observational Study
Brief Summary The 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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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 age-related macular degeneration (AMD).
Condition
  • Vascular Endothelial Growth Factor
  • Macular Degeneration
Intervention Other: No intervention
No intervention
Study Groups/Cohorts Not 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 Status Terminated
Actual Enrollment
 (submitted: February 25, 2011)
22
Original Estimated Enrollment
 (submitted: August 14, 2008)
100
Actual Study Completion Date August 2010
Actual Primary Completion Date August 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
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries India
Removed Location Countries  
 
Administrative Information
NCT Number NCT00735943
Other Study ID Numbers A5751031
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2011