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

Sponsor

Quark Pharmaceuticals (Industry)

Overall Status

Terminated

CT.gov ID

NCT00701181

Collaborator

Pfizer (Industry)

184

Enrollment

Locations

Arms

Duration (Months)

3.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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

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

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 Design

Study Type:

Interventional

Actual Enrollment :

184 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

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)

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Mean Change from Baseline in the Best Corrected Visual Acuity Score [Month 24]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Mesa	Arizona	United States	85210
2	Pfizer Investigational Site	Meza	Arizona	United States	85210
3	Pfizer Investigational Site	Peoria	Arizona	United States	85381
4	Pfizer Investigational Site	Phoenix	Arizona	United States	85014
5	Pfizer Investigational Site	Phoenix	Arizona	United States	85016
6	Pfizer Investigational Site	Mountain View	California	United States	94040
7	Pfizer Investigational Site	Lakeland	Florida	United States	33805
8	Pfizer Investigational Site	Winter Haven	Florida	United States	33880
9	Pfizer Investigational Site	Augusta	Georgia	United States	30909
10	Pfizer Investigational Site	Aiea	Hawaii	United States	96701
11	Pfizer Investigational Site	Chicago	Illinois	United States	60637
12	Pfizer Investigational Site	Indianapolis	Indiana	United States	46290
13	Pfizer Investigational Site	New Albany	Indiana	United States	47150
14	Pfizer Investigational Site	Baltimore	Maryland	United States	21287
15	Pfizer Investigational Site	Boston	Massachusetts	United States	02111
16	Pfizer Investigational Site	Boston	Massachusetts	United States	02215
17	Pfizer Investigational Site	Henderson	Nevada	United States	89052
18	Pfizer Investigational Site	Henderson	Nevada	United States	89074
19	Pfizer Investigational Site	Las Vegas	Nevada	United States	89109
20	Pfizer Investigational Site	Portsmouth	New Hampshire	United States	03801
21	Pfizer Investigational Site	Charlotte	North Carolina	United States	28210
22	Pfizer Investigational Site	High Point	North Carolina	United States	27262
23	Pfizer Investigational Site	Statesville	North Carolina	United States	28677
24	Pfizer Investigational Site	Winston-Salem	North Carolina	United States	27157
25	Pfizer Investigational Site	Rapid City	South Dakota	United States	57701
26	Pfizer Investigational Site	Corpus Christi	Texas	United States	78413
27	Pfizer Investigational Site	Glostrup		Denmark	2600
28	Pfizer Investigational Site	Freiburg		Germany	79106
29	Pfizer Investigational Site	Leipzig		Germany	04103
30	Pfizer Investigational Site	Muenster		Germany	48145
31	Pfizer Investigational Site	Bhubaneshwar	Orissa	India	751 024
32	Pfizer Investigational Site	Ahmedabad		India	380 004
33	Pfizer Investigational Site	Bangalore		India	560 085
34	Pfizer Investigational Site	New Delhi		India	110 029
35	Pfizer Investigational Site	Kfar Saba		Israel	44281
36	Pfizer Investigational Site	Petach - Tikva		Israel	49100
37	Pfizer Investigational Site	Tel Aviv		Israel	64239
38	Pfizer Investigational Site	Tel Hashomer		Israel	52621
39	Pfizer Investigational Site	Zerifin		Israel	70300
40	Pfizer Investigational Site	Milano		Italy	20122
41	Pfizer Investigational Site	Milano		Italy	20132
42	Pfizer Investigational Site	Milano		Italy	20157
43	Pfizer Investigational Site	Padova		Italy	35128
44	Pfizer Investigational Site	Roma		Italy	00168
45	Pfizer Investigational Site	Roma		Italy	00198
46	Pfizer Investigational Site	Udine		Italy	33100
47	Pfizer Investigational Site	Lima		Peru	L27
48	Pfizer Investigational Site	Frimley	Camberley, Surrey	United Kingdom	GU15 3UW
49	Pfizer Investigational Site	Bristol		United Kingdom	BS1 2LX
50	Pfizer Investigational Site	Bristol		United Kingdom	BS2 8HW
51	Pfizer Investigational Site	Liverpool		United Kingdom	L7 8XP
52	Pfizer Investigational Site	Sheffield		United Kingdom	S10 2JF
53	Pfizer Investigational Site	Southampton		United Kingdom	SO16 6YD