Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema

NCT00701181

Last updated date
Study Location
Pfizer Investigational Site
Mesa, Arizona, 85210, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetic Retinopathy, Diabetes Complications
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

- Patients with Diabetes Mellitus (Type 1 or Type 2) Showing Diabetic Macular Edema in the Eye.

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


- Proliferative Diabetic Retinopathy in the Study Eye.


- Subjects Receiving Concomitant Intravitreal Anti-VEGF Therapy.

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Diabetic Retinopathy, Diabetes ComplicationsStudy Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema
NCT00701181
  1. Mesa, Arizona
  2. Meza, Arizona
  3. Peoria, Arizona
  4. Phoenix, Arizona
  5. Phoenix, Arizona
  6. Mountain View, California
  7. Lakeland, Florida
  8. Winter Haven, Florida
  9. Augusta, Georgia
  10. Aiea, Hawaii
  11. Chicago, Illinois
  12. Indianapolis, Indiana
  13. New Albany, Indiana
  14. Baltimore, Maryland
  15. Boston, Massachusetts
  16. Boston, Massachusetts
  17. Henderson, Nevada
  18. Henderson, Nevada
  19. Las Vegas, Nevada
  20. Portsmouth, New Hampshire
  21. Charlotte, North Carolina
  22. High Point, North Carolina
  23. Statesville, North Carolina
  24. Winston-Salem, North Carolina
  25. Rapid City, South Dakota
  26. Corpus Christi, Texas
  27. Glostrup,
  28. Freiburg,
  29. Leipzig,
  30. Muenster,
  31. Bhubaneshwar, Orissa
  32. Ahmedabad,
  33. Bangalore,
  34. New Delhi,
  35. Kfar Saba,
  36. Petach - Tikva,
  37. Tel Aviv,
  38. Tel Hashomer,
  39. Zerifin,
  40. Milano,
  41. Milano,
  42. Milano,
  43. Padova,
  44. Roma,
  45. Roma,
  46. Udine,
  47. Lima,
  48. Frimley, Camberley, Surrey
  49. Bristol,
  50. Bristol,
  51. Liverpool,
  52. Sheffield,
  53. Southampton,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema
Official Title  ICMJE A Phase II Prospective, Randomized, Multi-Center, Diabetic Macular Edema Dose Ranging, Comparator Study Evaluating The Efficacy And Safety Of PF-04523655 Versus Laser Therapy (DEGAS)
Brief Summary To evaluate the effectiveness of study drug in improving visual acuity compared to laser treatment in the patients with diabetic macular edema
Detailed Description DEGAS termination decision date was December 17, 2010. Rationale: the objectives of the study could no longer be achieved. The study was not terminated for safety.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetic Retinopathy
  • Diabetes Complications
Intervention  ICMJE
  • Procedure: Laser Treatment
    Necessity of laser treatment is assessed every three months.
  • Drug: PF-04523655 high
    3 mg intravitreal injection
  • Drug: PF-04523655 middle
    1 mg intravitreal injection
  • Drug: PF-04523655 low
    0.4 mg intravitreal injection
Study Arms  ICMJE
  • Active Comparator: Laser
    This is a procedure - not a drug intervention.
    Intervention: Procedure: Laser Treatment
  • Experimental: PF-04523655 (High)
    Intervention: Drug: PF-04523655 high
  • Experimental: PF-04523655 middle
    Intervention: Drug: PF-04523655 middle
  • Experimental: PF-04523655 low
    Intervention: Drug: PF-04523655 low
Publications * Nguyen QD, Schachar RA, Nduaka CI, Sperling M, Basile AS, Klamerus KJ, Chi-Burris K, Yan E, Paggiarino DA, Rosenblatt I, Aitchison R, Erlich SS; DEGAS Clinical Study Group. Dose-ranging evaluation of intravitreal siRNA PF-04523655 for diabetic macular edema (the DEGAS study). Invest Ophthalmol Vis Sci. 2012 Nov 15;53(12):7666-74. doi: 10.1167/iovs.12-9961.

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: February 22, 2011)
184
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2008)
160
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with Diabetes Mellitus (Type 1 or Type 2) Showing Diabetic Macular Edema in the Eye.

Exclusion Criteria:

  • Proliferative Diabetic Retinopathy in the Study Eye.
  • Subjects Receiving Concomitant Intravitreal Anti-VEGF Therapy.
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 Denmark,   Germany,   India,   Israel,   Italy,   Peru,   United Kingdom,   United States
Removed Location Countries Brazil
 
Administrative Information
NCT Number  ICMJE NCT00701181
Other Study ID Numbers  ICMJE B0451004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Quark Pharmaceuticals
Study Sponsor  ICMJE Quark Pharmaceuticals
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Quark Pharmaceuticals
Verification Date October 2012

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