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A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.

Last updated on November 16, 2019

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Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85020 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Macular Edema Associated With Diabetes Mellitus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- macular edema associated with diabetes

- visual acuity between 20/50 and 20/200

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

- recent laser therapy in the eye

- recent signs of uncontrolled diabetes

- blood pressure worse than 160/100

- severe cardiac disease

NCT00605280
Pfizer
Completed
A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.

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Descriptive Information
Brief Title  ICMJE A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.
Official Title  ICMJE A Phase 2/3 Randomized, Controlled, Double-Masked, Multi-Center, Comparative Trial, In Parallel Groups, To Compare The Safety And Efficacy Of Intravitreous Injections Of 0.3 Mg Pegaptanib Sodium (Macugen®), Given As Often As Every 6 Weeks For 2 Years, To Sham Injections In Subjects With Diabetic Macular Edema (DME) Involving The Center Of The Macula With An Open-Label Macugen Year 3 Extension.
Brief SummaryThe purpose of the study is to test whether Macugen injected into the eye improves vision in more patients than the currently existing standard of care laser therapy. The safety of Macugen compared to standard of care laser will also be evaluated.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Macular Edema Associated With Diabetes Mellitus
Intervention  ICMJE
  • Drug: Standard of Care
    Clinicians decision to use optional laser therapy.
  • Drug: Macugen
    Intravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.
Study Arms  ICMJE
  • Sham Comparator: Sham Control
    Intervention: Drug: Standard of Care
  • Experimental: Macugen
    Intervention: Drug: Macugen
Publications *Loftus JV, Sultan MB, Pleil AM; Macugen 1013 Study Group. Changes in vision- and health-related quality of life in patients with diabetic macular edema treated with pegaptanib sodium or sham. Invest Ophthalmol Vis Sci. 2011 Sep 29;52(10):7498-505. doi: 10.1167/iovs.11-7613.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 3, 2011)
317
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2008)
300
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion DateNovember 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • macular edema associated with diabetes
  • visual acuity between 20/50 and 20/200

Exclusion Criteria:

  • recent laser therapy in the eye
  • recent signs of uncontrolled diabetes
  • blood pressure worse than 160/100
  • severe cardiac disease
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Brazil,   Canada,   Colombia,   Czechia,   Denmark,   France,   Germany,   Greece,   India,   Italy,   Netherlands,   Portugal,   South Africa,   Switzerland,   United Kingdom,   United States
Removed Location CountriesCzech Republic
 
Administrative Information
NCT Number  ICMJE NCT00605280
Other Study ID Numbers  ICMJE A5751013
EOP1013H
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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