A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration In Real Life.

NCT00549055

Last updated date
Study Location
Pfizer Investigational Site
Aarschot, , 3200, Belgium
Contact
1-800-718-1021

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1-800-718-1021

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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
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients diagnosed with subfoveal neovascular (wet) age-related macular degeneration

- Patients having received at least 1 Macugen injection

- Treatment naive patients, or patients having received conventional therapy

- Patients having signed and dated informed consent.

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


- Patients participating in another clinical study with Macugen.

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Advanced Information
Descriptive Information
Brief Title A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration In Real Life.
Official Title A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration (AMD) In Real Life (Macureli Study).
Brief Summary To assess effectiveness of Macugen for treatment of neovascular age-related macular degeneration by measuring the evolution of visual acuity. Treatment duration, frequency of administration and combination with other treatments will also be evaluated.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients who obtained reimbursement for Macugen, recruited by retina specialists from ophthalmology centres with experience in intravitreal injections.
Condition Neovascular Age-related Macular Degeneration
Intervention Drug: Macugen
Dosage form: solution for injection (intravitreal) Dosage: 0.3mg Frequency: every 6 weeks (9 injections/year)
Other Name: Pegaptanib sodium
Study Groups/Cohorts 1
Patients who obtained reimbursement of Macugen.
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 Completed
Actual Enrollment
 (submitted: October 1, 2010)
38
Original Enrollment
 (submitted: October 23, 2007)
100
Actual Study Completion Date October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients diagnosed with subfoveal neovascular (wet) age-related macular degeneration
  • Patients having received at least 1 Macugen injection
  • Treatment naive patients, or patients having received conventional therapy
  • Patients having signed and dated informed consent.

Exclusion Criteria:

  • Patients participating in another clinical study with Macugen.
Sex/Gender
Sexes Eligible for Study:All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT00549055
Other Study ID Numbers A5751026
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 November 2018