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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

Study Description
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Brief Summary:
To evaluate the effectiveness of study drug in improving visual acuity compared to laser treatment in the patients with diabetic macular edema

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Diabetes Complications Procedure: Laser Treatment Drug: PF-04523655 high Drug: PF-04523655 middle Drug: PF-04523655 low Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : June 2008
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Laser
This is a procedure - not a drug intervention.
 Procedure: Laser Treatment
Necessity of laser treatment is assessed every three months.
Experimental: PF-04523655 (High) Drug: PF-04523655 high
3 mg intravitreal injection
Experimental: PF-04523655 middle Drug: PF-04523655 middle
1 mg intravitreal injection
Experimental: PF-04523655 low Drug: PF-04523655 low
0.4 mg intravitreal injection


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change from Baseline in the Best Corrected Visual Acuity Score [ Time Frame: Month 24 ]

Secondary Outcome Measures :
  1. Mean Changes in NEI-VFQ-25 Composite Score from Baseline [ Time Frame: Month 24, 36 ]
  2. Plasma Concentration of PF-04523655 [ Time Frame: Week 1 ]
  3. Percent of Subjects Gaining Letters in the Best Corrected Visual Acuity Score from Baseline. [ Time Frame: Month 24, 36 ]
  4. Incidence and Severity of Ocular and Systemic Adverse Events, as Identified by Ophthalmic Examination [ Time Frame: Month 24, 36 ]
  5. Mean Change from Baseline in the Best Corrected Visual Acuity Score [ Time Frame: Month 36 ]
  6. Mean Changes in Area of Fluorescein Leakage from Baseline [ Time Frame: Month 24, 36 ]
  7. Percent of Subjects Losing Letters in the Best Corrected Visual Acuity Score from Baseline. [ Time Frame: Month 24, 36 ]
  8. Mean Changes in Retinal Thickness from Baseline [ Time Frame: Month 24, 36 ]
  9. Mean Changes in Macular Volume from Baseline [ Time Frame: Month 24, 36 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00701181


  Show 53 Study Locations
Sponsors and Collaborators
Quark Pharmaceuticals
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Quark Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00701181     History of Changes
Other Study ID Numbers: B0451004
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: October 11, 2012
Last Verified: October 2012

Keywords provided by Quark Pharmaceuticals:
Phase II
Prospective
Randomized
 Diabetic Macular Edema
PF-04523655
Laser

Additional relevant MeSH terms:
Macular Edema
Diabetic Retinopathy
Diabetes Complications
Macular Degeneration
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Mellitus
Endocrine System Diseases