A Phase 3 Study To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium To Sham Injections In Subjects With Diabetic Macular Edema

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NCT01100307

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Study Location
Nagoya City University Hospital
Nagoya, Aichi, , Japan
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Macular Edema, Diabetic Mellitus, Retinal Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Type I, or Type II diabetic subjects

- Subjects must have macular edema that involves the center field of the macula 3. Foveal thickness of at least 250 μm 4. Best corrected distance visual acuity in the study eye must be a letter score between 68 and 35 inclusive

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


- Eyes with prior panretinal photocoagulation (PRP) less than 4 months prior to baseline
eyes in which PRP is needed now or is likely to be needed within the next 9 months


- HbA1C level >12% or recent signs of uncontrolled diabetes


- Atrophy/scarring/fibrosis involving the center of the macula, including evidence of
laser treated atrophy

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Macular Edema, Diabetic Mellitus, Retinal DiseaseA Phase 3 Study To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium To Sham Injections In Subjects With Diabetic Macular Edema NCT01100307
  1. Nagoya, Aichi
  2. Nagoya, Aichi
  3. Nagoya, Aichi
  4. Urayasu-shi, Chiba-Ken
  5. Kurume, Fukuoka
  6. Maebashi, Gumma
  7. Kure, Hiroshima
  8. Asahikawa, Hokkaido
  9. Hakodate, Hokkaido
  10. Sapporo, Hokkaido
  11. Amagasaki, Hyogo
  12. Kobe, Hyogo
  13. Kobe, Hyogo
  14. Hitachi, Ibaraki
  15. Mito, Ibaraki
  16. Kida-gun, Kagawa
  17. Sendai, Miyagi
  18. Matsumoto, Nagano
  19. Kashihara, Nara
  20. Osaka-sayama-shi, Osaka
  21. Otsu, Shiga
  22. Hamamatsu, Shizuoka
  23. Chiyoda-ku, Tokyo
  24. Chiyoda-ku, Tokyo
  25. Meguro-ku, Tokyo
  26. Shinjuku-ku, Tokyo
  27. Shunan, Yamaguchi
  28. Akita,
  29. Aomori,
  30. Chiba,
  31. Fukuoka,
  32. Fukuoka,
  33. Fukuoka,
  34. Fukuoka,
  35. Fukushima,
  36. Kagoshima,
  37. Kumamoto,
  38. Kyoto,
  39. Niigata,
  40. Osaka,
  41. Osaka,
  42. Osaka,
  43. Saga,
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 3 Study To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium To Sham Injections In Subjects With Diabetic Macular Edema
Official Title  ICMJE A Phase 3, Randomized, Controlled, Double-Masked, Multi-Center, Comparative, In Parallel Groups (For 24 Weeks), To Compare The Efficacy And Safety Of 0.3 MG Pegaptanib Sodium, With Sham Injections, And Open Study (For 30 Weeks) To Confirm The Safety Of 0.3 MG Pegaptanib Sodium In Subjects With Diabetic Macular Edema (DME)
Brief Summary The purpose of the study to assess the efficacy of pegaptanib sodium 0.3 mg comparing sham injection and to confirm safety of pegaptanib sodium 0.3 mg in subjects with diabetic macular edema.
Detailed Description During the study, an issue was reported concerning proper maintenance of treatment masking (See Result: Limitations and Caveats)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Macular Edema
  • Diabetic Mellitus
  • Retinal Disease
Intervention  ICMJE
  • Drug: pegaptanib sodium
    Intravitreal injection of 0.3 mg every 6 weeks
  • Other: sham injection
    sham injection every 6 weeks
Study Arms  ICMJE
  • Experimental: pegaptanib sodium
    Intervention: Drug: pegaptanib sodium
  • Sham Comparator: sham injection
    Intervention: Other: sham injection
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 14, 2012)		243
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2010)		240
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Type I, or Type II diabetic subjects
  • Subjects must have macular edema that involves the center field of the macula 3. Foveal thickness of at least 250 ?m 4. Best corrected distance visual acuity in the study eye must be a letter score between 68 and 35 inclusive

Exclusion Criteria:

  • Eyes with prior panretinal photocoagulation (PRP) less than 4 months prior to baseline eyes in which PRP is needed now or is likely to be needed within the next 9 months
  • HbA1C level >12% or recent signs of uncontrolled diabetes
  • Atrophy/scarring/fibrosis involving the center of the macula, including evidence of laser treated atrophy
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01100307
Other Study ID Numbers  ICMJE A5751034
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP