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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Quark Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00701181
First received: June 17, 2008
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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)

Resource links provided by NLM:


Further study details as provided by Quark Pharmaceuticals:

Primary Outcome Measures:
  • Mean Change from Baseline in the Best Corrected Visual Acuity Score [ Time Frame: Month 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Changes in NEI-VFQ-25 Composite Score from Baseline [ Time Frame: Month 24, 36 ] [ Designated as safety issue: No ]
  • Plasma Concentration of PF-04523655 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
  • Percent of Subjects Gaining Letters in the Best Corrected Visual Acuity Score from Baseline. [ Time Frame: Month 24, 36 ] [ Designated as safety issue: No ]
  • Incidence and Severity of Ocular and Systemic Adverse Events, as Identified by Ophthalmic Examination [ Time Frame: Month 24, 36 ] [ Designated as safety issue: Yes ]
  • Mean Change from Baseline in the Best Corrected Visual Acuity Score [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
  • Mean Changes in Area of Fluorescein Leakage from Baseline [ Time Frame: Month 24, 36 ] [ Designated as safety issue: Yes ]
  • Percent of Subjects Losing Letters in the Best Corrected Visual Acuity Score from Baseline. [ Time Frame: Month 24, 36 ] [ Designated as safety issue: Yes ]
  • Mean Changes in Retinal Thickness from Baseline [ Time Frame: Month 24, 36 ] [ Designated as safety issue: Yes ]
  • Mean Changes in Macular Volume from Baseline [ Time Frame: Month 24, 36 ] [ Designated as safety issue: No ]

Enrollment: 184
Study Start Date: June 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701181

  Show 53 Study Locations
Sponsors and Collaborators
Quark Pharmaceuticals
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Quark Pharmaceuticals

Additional 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
Study First Received: June 17, 2008
Last Updated: October 9, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014