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

Primary Purpose

Diabetic Retinopathy, Diabetes Complications

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Laser Treatment

PF-04523655 high

PF-04523655 middle

PF-04523655 low

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Phase II, Prospective, Randomized, Diabetic Macular Edema, PF-04523655, Laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Arm Label

Laser

PF-04523655 (High)

PF-04523655 middle

PF-04523655 low

Arm Description

This is a procedure - not a drug intervention.

Outcomes

Primary Outcome Measures

Mean Change from Baseline in the Best Corrected Visual Acuity Score

Secondary Outcome Measures

Mean Changes in NEI-VFQ-25 Composite Score from Baseline

Plasma Concentration of PF-04523655

Percent of Subjects Gaining Letters in the Best Corrected Visual Acuity Score from Baseline.

Incidence and Severity of Ocular and Systemic Adverse Events, as Identified by Ophthalmic Examination

Mean Change from Baseline in the Best Corrected Visual Acuity Score

Mean Changes in Area of Fluorescein Leakage from Baseline

Percent of Subjects Losing Letters in the Best Corrected Visual Acuity Score from Baseline.

Mean Changes in Retinal Thickness from Baseline

Mean Changes in Macular Volume from Baseline

Full Information

NCT ID

NCT00701181

First Posted

June 17, 2008

Last Updated

October 9, 2012

Sponsor

Quark Pharmaceuticals

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00701181

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Terminated

Why Stopped

See termination reason in detailed description.

Study Start Date

June 2008 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Quark Pharmaceuticals

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Retinopathy, Diabetes Complications

Keywords

Phase II, Prospective, Randomized, Diabetic Macular Edema, PF-04523655, Laser

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

184 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Laser

Arm Type

Active Comparator

Arm Description

This is a procedure - not a drug intervention.

Arm Title

PF-04523655 (High)

Arm Type

Experimental

Arm Title

PF-04523655 middle

Arm Type

Experimental

Arm Title

PF-04523655 low

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Laser Treatment

Intervention Description

Necessity of laser treatment is assessed every three months.

Intervention Type

Drug

Intervention Name(s)

PF-04523655 high

Intervention Description

3 mg intravitreal injection

Intervention Type

Drug

Intervention Name(s)

PF-04523655 middle

Intervention Description

1 mg intravitreal injection

Intervention Type

Drug

Intervention Name(s)

PF-04523655 low

Intervention Description

0.4 mg intravitreal injection

Primary Outcome Measure Information:

Title

Mean Change from Baseline in the Best Corrected Visual Acuity Score

Time Frame

Month 24

Secondary Outcome Measure Information:

Title

Mean Changes in NEI-VFQ-25 Composite Score from Baseline

Time Frame

Month 24, 36

Title

Plasma Concentration of PF-04523655

Time Frame

Week 1

Title

Percent of Subjects Gaining Letters in the Best Corrected Visual Acuity Score from Baseline.

Time Frame

Month 24, 36

Title

Incidence and Severity of Ocular and Systemic Adverse Events, as Identified by Ophthalmic Examination

Time Frame

Month 24, 36

Title

Mean Change from Baseline in the Best Corrected Visual Acuity Score

Time Frame

Month 36

Title

Mean Changes in Area of Fluorescein Leakage from Baseline

Time Frame

Month 24, 36

Title

Percent of Subjects Losing Letters in the Best Corrected Visual Acuity Score from Baseline.

Time Frame

Month 24, 36

Title

Mean Changes in Retinal Thickness from Baseline

Time Frame

Month 24, 36

Title

Mean Changes in Macular Volume from Baseline

Time Frame

Month 24, 36

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Pfizer Investigational Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85210

Country

United States

Facility Name

Pfizer Investigational Site

City

Meza

State/Province

Arizona

ZIP/Postal Code

85210

Country

United States

Facility Name

Pfizer Investigational Site

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85014

Country

United States

Facility Name

Pfizer Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Facility Name

Pfizer Investigational Site

City

Mountain View

State/Province

California

ZIP/Postal Code

94040

Country

United States

Facility Name

Pfizer Investigational Site

City

Lakeland

State/Province

Florida

ZIP/Postal Code

33805

Country

United States

Facility Name

Pfizer Investigational Site

City

Winter Haven

State/Province

Florida

ZIP/Postal Code

33880

Country

United States

Facility Name

Pfizer Investigational Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

Facility Name

Pfizer Investigational Site

City

Aiea

State/Province

Hawaii

ZIP/Postal Code

96701

Country

United States

Facility Name

Pfizer Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Pfizer Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46290

Country

United States

Facility Name

Pfizer Investigational Site

City

New Albany

State/Province

Indiana

ZIP/Postal Code

47150

Country

United States

Facility Name

Pfizer Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Pfizer Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Pfizer Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Pfizer Investigational Site

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89052

Country

United States

Facility Name

Pfizer Investigational Site

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89074

Country

United States

Facility Name

Pfizer Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89109

Country

United States

Facility Name

Pfizer Investigational Site

City

Portsmouth

State/Province

New Hampshire

ZIP/Postal Code

03801

Country

United States

Facility Name

Pfizer Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

Pfizer Investigational Site

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Pfizer Investigational Site

City

Statesville

State/Province

North Carolina

ZIP/Postal Code

28677

Country

United States

Facility Name

Pfizer Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Pfizer Investigational Site

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

Pfizer Investigational Site

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78413

Country

United States

Facility Name

Pfizer Investigational Site

City

Glostrup

ZIP/Postal Code

2600

Country

Denmark

Facility Name

Pfizer Investigational Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Pfizer Investigational Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Pfizer Investigational Site

City

Muenster

ZIP/Postal Code

48145

Country

Germany

Facility Name

Pfizer Investigational Site

City

Bhubaneshwar

State/Province

Orissa

ZIP/Postal Code

751 024

Country

India

Facility Name

Pfizer Investigational Site

City

Ahmedabad

ZIP/Postal Code

380 004

Country

India

Facility Name

Pfizer Investigational Site

City

Bangalore

ZIP/Postal Code

560 085

Country

India

Facility Name

Pfizer Investigational Site

City

New Delhi

ZIP/Postal Code

110 029

Country

India

Facility Name

Pfizer Investigational Site

City

Kfar Saba

ZIP/Postal Code

44281

Country

Israel

Facility Name

Pfizer Investigational Site

City

Petach - Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Pfizer Investigational Site

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Pfizer Investigational Site

City

Tel Hashomer

ZIP/Postal Code

52621

Country

Israel

Facility Name

Pfizer Investigational Site

City

Zerifin

ZIP/Postal Code

70300

Country

Israel

Facility Name

Pfizer Investigational Site

City

Milano

ZIP/Postal Code

20122

Country

Italy

Facility Name

Pfizer Investigational Site

City

Milano

ZIP/Postal Code

20132

Country

Italy

Facility Name

Pfizer Investigational Site

City

Milano

ZIP/Postal Code

20157

Country

Italy

Facility Name

Pfizer Investigational Site

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Pfizer Investigational Site

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Pfizer Investigational Site

City

Roma

ZIP/Postal Code

00198

Country

Italy

Facility Name

Pfizer Investigational Site

City

Udine

ZIP/Postal Code

33100

Country

Italy

Facility Name

Pfizer Investigational Site

City

Lima

ZIP/Postal Code

L27

Country

Peru

Facility Name

Pfizer Investigational Site

City

Frimley

State/Province

Camberley, Surrey

ZIP/Postal Code

GU15 3UW

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Bristol

ZIP/Postal Code

BS1 2LX

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Bristol

ZIP/Postal Code

BS2 8HW

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Liverpool

ZIP/Postal Code

L7 8XP

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Sheffield

ZIP/Postal Code

S10 2JF

Country

United Kingdom

Facility Name

Pfizer Investigational Site

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

23074206

Citation

Nguyen QD, Schachar RA, Nduaka CI, Sperling M, Basile AS, Klamerus KJ, Chi-Burris K, Yan E, Paggiarino DA, Rosenblatt I, Aitchison R, Erlich SS; DEGAS Clinical Study Group. Dose-ranging evaluation of intravitreal siRNA PF-04523655 for diabetic macular edema (the DEGAS study). Invest Ophthalmol Vis Sci. 2012 Nov 15;53(12):7666-74. doi: 10.1167/iovs.12-9961.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0451004&StudyName=Prospective%2C%20Randomized%2C%20Multi-Center%2C%20Comparator%20Study%20Evaluating%20Efficacy%20and%20Safety%20of%20PF-04523655%20versus%20Laser%20in%20Subjects%20with%20Diab

Description

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Learn more about this trial

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

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

Diabetic Retinopathy, Diabetes Complications

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial