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NCT00701181 Clinical Trial

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

Diabetic Retinopathy Clinical Trial

— DEGAS  

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)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00701181
Other study ID # B0451004
Secondary ID
Status Terminated
Phase Phase 2
First received June 17, 2008
Last updated October 9, 2012
Start date June 2008
Est. completion date January 2011

Study information
Verified date October 2012
Source Quark Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 184
Est. completion date January 2011
Est. primary completion date January 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Laser Treatment
Necessity of laser treatment is assessed every three months.
Drug:
• PF-04523655 high
3 mg intravitreal injection
• PF-04523655 middle
1 mg intravitreal injection
• PF-04523655 low
0.4 mg intravitreal injection

Locations
Country Name City State
Denmark Pfizer Investigational Site Glostrup
Germany Pfizer Investigational Site Freiburg
Germany Pfizer Investigational Site Leipzig
Germany Pfizer Investigational Site Muenster
India Pfizer Investigational Site Ahmedabad
India Pfizer Investigational Site Bangalore
India Pfizer Investigational Site Bhubaneshwar Orissa
India Pfizer Investigational Site New Delhi
Israel Pfizer Investigational Site Kfar Saba
Israel Pfizer Investigational Site Petach - Tikva
Israel Pfizer Investigational Site Tel Aviv
Israel Pfizer Investigational Site Tel Hashomer
Israel Pfizer Investigational Site Zerifin
Italy Pfizer Investigational Site Milano
Italy Pfizer Investigational Site Milano
Italy Pfizer Investigational Site Milano
Italy Pfizer Investigational Site Padova
Italy Pfizer Investigational Site Roma
Italy Pfizer Investigational Site Roma
Italy Pfizer Investigational Site Udine
Peru Pfizer Investigational Site Lima
United Kingdom Pfizer Investigational Site Bristol
United Kingdom Pfizer Investigational Site Bristol
United Kingdom Pfizer Investigational Site Frimley Camberley, Surrey
United Kingdom Pfizer Investigational Site Liverpool
United Kingdom Pfizer Investigational Site Sheffield
United Kingdom Pfizer Investigational Site Southampton
United States Pfizer Investigational Site Aiea Hawaii
United States Pfizer Investigational Site Augusta Georgia
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Corpus Christi Texas
United States Pfizer Investigational Site Henderson Nevada
United States Pfizer Investigational Site Henderson Nevada
United States Pfizer Investigational Site High Point North Carolina
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Lakeland Florida
United States Pfizer Investigational Site Las Vegas Nevada
United States Pfizer Investigational Site Mesa Arizona
United States Pfizer Investigational Site Meza Arizona
United States Pfizer Investigational Site Mountain View California
United States Pfizer Investigational Site New Albany Indiana
United States Pfizer Investigational Site Peoria Arizona
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Portsmouth New Hampshire
United States Pfizer Investigational Site Rapid City South Dakota
United States Pfizer Investigational Site Statesville North Carolina
United States Pfizer Investigational Site Winston-Salem North Carolina
United States Pfizer Investigational Site Winter Haven Florida

Sponsors (2)
Lead Sponsor Collaborator
Quark Pharmaceuticals Pfizer

Countries where clinical trial is conducted

United States,  Denmark,  Germany,  India,  Israel,  Italy,  Peru,  United Kingdom, 

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