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Trial record 1 of 1 for:    NCT00701181
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Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema (DEGAS)

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ClinicalTrials.gov Identifier: NCT00701181
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : June 19, 2008
Last Update Posted : October 11, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Quark Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 17, 2008
First Posted Date  ICMJE June 19, 2008
Last Update Posted Date October 11, 2012
Study Start Date  ICMJE June 2008
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2008)
Mean Change from Baseline in the Best Corrected Visual Acuity Score [ Time Frame: Month 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2008)
  • Mean Changes in NEI-VFQ-25 Composite Score from Baseline [ Time Frame: Month 24, 36 ]
  • Plasma Concentration of PF-04523655 [ Time Frame: Week 1 ]
  • Percent of Subjects Gaining Letters in the Best Corrected Visual Acuity Score from Baseline. [ Time Frame: Month 24, 36 ]
  • Incidence and Severity of Ocular and Systemic Adverse Events, as Identified by Ophthalmic Examination [ Time Frame: Month 24, 36 ]
  • Mean Change from Baseline in the Best Corrected Visual Acuity Score [ Time Frame: Month 36 ]
  • Mean Changes in Area of Fluorescein Leakage from Baseline [ Time Frame: Month 24, 36 ]
  • Percent of Subjects Losing Letters in the Best Corrected Visual Acuity Score from Baseline. [ Time Frame: Month 24, 36 ]
  • Mean Changes in Retinal Thickness from Baseline [ Time Frame: Month 24, 36 ]
  • Mean Changes in Macular Volume from Baseline [ Time Frame: Month 24, 36 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2008)
  • Mean Changes in Area of Fluorescein Leakage from Baseline [ Time Frame: Month 24, 36 ]
  • Percent of Subjects Losing Letters in the Best Corrected Visual Acuity Score from Baseline. [ Time Frame: Month 24, 36 ]
  • Mean Changes in Retinal Thickness from Baseline [ Time Frame: Month 24, 36 ]
  • Mean Changes in Macular Volume from Baseline [ Time Frame: Month 24, 36 ]
  • Mean Changes in NEI-VFQ-25 Composite Score from Baseline [ Time Frame: Month 24, 36 ]
  • Plasma Concentration of PF-04523655 [ Time Frame: Week 1 ]
  • Percent of Subjects Gaining Letters in the Best Corrected Visual Acuity Score from Baseline. [ Time Frame: Month 24, 36 ]
  • Incidence and Severity of Ocular and Systemic Adverse Events, as Identified by Ophthalmic Examination [ Time Frame: Month 24, 36 ]
  • Mean Change from Baseline in the Best Corrected Visual Acuity Score [ Time Frame: Month 36 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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