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

October 9, 2012 updated by: Quark Pharmaceuticals

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)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

184

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Glostrup, Denmark, 2600
        • Pfizer Investigational Site
  • Germany
      • Freiburg, Germany, 79106
        • Pfizer Investigational Site
      • Leipzig, Germany, 04103
        • Pfizer Investigational Site
      • Muenster, Germany, 48145
        • Pfizer Investigational Site
  • India
      • Ahmedabad, India, 380 004
        • Pfizer Investigational Site
      • Bangalore, India, 560 085
        • Pfizer Investigational Site
      • New Delhi, India, 110 029
        • Pfizer Investigational Site
    • Orissa
      • Bhubaneshwar, Orissa, India, 751 024
        • Pfizer Investigational Site
  • Israel
      • Kfar Saba, Israel, 44281
        • Pfizer Investigational Site
      • Petach - Tikva, Israel, 49100
        • Pfizer Investigational Site
      • Tel Aviv, Israel, 64239
        • Pfizer Investigational Site
      • Tel Hashomer, Israel, 52621
        • Pfizer Investigational Site
      • Zerifin, Israel, 70300
        • Pfizer Investigational Site
  • Italy
      • Milano, Italy, 20132
        • Pfizer Investigational Site
      • Milano, Italy, 20122
        • Pfizer Investigational Site
      • Milano, Italy, 20157
        • Pfizer Investigational Site
      • Padova, Italy, 35128
        • Pfizer Investigational Site
      • Roma, Italy, 00168
        • Pfizer Investigational Site
      • Roma, Italy, 00198
        • Pfizer Investigational Site
      • Udine, Italy, 33100
        • Pfizer Investigational Site
  • Peru
      • Lima, Peru, L27
        • Pfizer Investigational Site
  • United Kingdom
      • Bristol, United Kingdom, BS1 2LX
        • Pfizer Investigational Site
      • Bristol, United Kingdom, BS2 8HW
        • Pfizer Investigational Site
      • Liverpool, United Kingdom, L7 8XP
        • Pfizer Investigational Site
      • Sheffield, United Kingdom, S10 2JF
        • Pfizer Investigational Site
      • Southampton, United Kingdom, SO16 6YD
        • Pfizer Investigational Site
    • Camberley, Surrey
      • Frimley, Camberley, Surrey, United Kingdom, GU15 3UW
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85210
        • Pfizer Investigational Site
      • Meza, Arizona, United States, 85210
        • Pfizer Investigational Site
      • Peoria, Arizona, United States, 85381
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85016
        • Pfizer Investigational Site
      • Phoenix, Arizona, United States, 85014
        • Pfizer Investigational Site
    • California
      • Mountain View, California, United States, 94040
        • Pfizer Investigational Site
    • Florida
      • Lakeland, Florida, United States, 33805
        • Pfizer Investigational Site
      • Winter Haven, Florida, United States, 33880
        • Pfizer Investigational Site
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Pfizer Investigational Site
    • Hawaii
      • Aiea, Hawaii, United States, 96701
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Pfizer Investigational Site
      • New Albany, Indiana, United States, 47150
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02215
        • Pfizer Investigational Site
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Pfizer Investigational Site
      • Henderson, Nevada, United States, 89074
        • Pfizer Investigational Site
      • Las Vegas, Nevada, United States, 89109
        • Pfizer Investigational Site
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Pfizer Investigational Site
      • High Point, North Carolina, United States, 27262
        • Pfizer Investigational Site
      • Statesville, North Carolina, United States, 28677
        • Pfizer Investigational Site
      • Winston-Salem, North Carolina, United States, 27157
        • Pfizer Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Pfizer Investigational Site
    • Texas
      • Corpus Christi, Texas, United States, 78413
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean Change from Baseline in the Best Corrected Visual Acuity Score
Time Frame: Month 24
Month 24

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quark Pharmaceuticals

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria

June 18, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Estimate)

October 11, 2012

Last Update Submitted That Met QC Criteria

October 9, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B0451004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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