Prospective, Randomized, Multi-Center, Comparator Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema (DEGAS)
Prospective, Randomized, Multi-Center, Comparator Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema (DEGAS)
ClinicalTrials.gov
This study is currently recruiting participants.
Verified by Pfizer, October 2008
Sponsored by: Pfizer
Information provided by: Pfizer
ClinicalTrials.gov Identifier: NCT00701181
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 Procedure: Laser Treatment Phase II
Diabetes Complications Drug: PF-04523655 high
Drug: PF-04523655 middle
Drug: PF-04523655 low
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study
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)
Further study details as provided by Pfizer:
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 ]
Estimated Enrollment: 160
Study Start Date: June 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Laser: No Intervention Procedure: Laser Treatment
Necessity of laser treatment is assessed
every three months.
PF-04523655 (High):
Experimental Drug: PF-04523655 high 3 mg intravitreal injection
PF-04523655 middle:
Experimental Drug: PF-04523655 middle
1 mg intravitreal injection
PF-04523655 low:
Experimental Drug: PF-04523655 low
0.4 mg intravitreal injection
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00701181
Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Locations
United States, California
Pfizer Investigational Site Recruiting
Mountain View, California, United States, 94040
United States, Florida
Pfizer Investigational Site Recruiting
Winter Haven, Florida, United States, 33880
United States, Georgia
Pfizer Investigational Site Recruiting
Augusta, Georgia, United States, 30909
United States, Indiana
Pfizer Investigational Site Recruiting
Indianapolis, Indiana, United States, 46280
Pfizer Investigational Site Recruiting
New Albany, Indiana, United States, 47150
United States, Massachusetts
Pfizer Investigational Site Recruiting
Boston, Massachusetts, United States, 02215
United States, Missouri
Pfizer Investigational Site Recruiting
Columbia, Missouri, United States, 65212
United States, Nevada
Pfizer Investigational Site Recruiting
Henderson, Nevada, United States, 89052
Pfizer Investigational Site Recruiting
Henderson, Nevada, United States, 89074
Pfizer Investigational Site Recruiting
Las Vegas, Nevada, United States, 89109
United States, North Carolina
Pfizer Investigational Site Not yet recruiting
High Point, North Carolina, United States, 27262
Pfizer Investigational Site Recruiting
Charlotte, North Carolina, United States, 28210
Pfizer Investigational Site Recruiting
Statesville, North Carolina, United States, 28677
United States, South Dakota
Pfizer Investigational Site Recruiting
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Pfizer Investigational Site Recruiting
Memphis, Tennessee, United States, 38119
United States, Texas
Pfizer Investigational Site Recruiting
Corpus Christi, Texas, United States, 78413
Denmark
Pfizer Investigational Site Not yet recruiting
Glostrup, Denmark, 2600
United Kingdom
Pfizer Investigational Site Recruiting
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site
Responsible Party: Pfizer Inc ( Tomoko Maeda )
Study ID Numbers: B0451004
First Received: June 17, 2008
Last Updated: October 9, 2008
ClinicalTrials.gov Identifier: NCT00701181
Health Authority: United States: Food and Drug Administration
Keywords provided by Pfizer:
Phase II, Prospective, Randomized, Diabetic Macular Edema, PF-04523655, Laser
Study placed in the following topic categories:
Simethicone
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Edema
Endocrine System Diseases
Macular Degeneration
Retinal Degeneration
Diabetic Angiopathies
Macular Edema
Diabetic Retinopathy
Endocrinopathy
Retinal Diseases
Diabetes Complications
Retinal degeneration
Additional relevant MeSH terms:
Cardiovascular Diseases
ClinicalTrials.gov processed this record on December 04, 2008
