Clinical trial NCT00701181: Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Retinopathy
Diabetes Complications
Keywords: Phase II
Prospective
Randomized
Diabetic Macular Edema
PF-04523655
Laser
Lead sponsor: Quark Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2008-06-19
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean Change from Baseline in the Best Corrected Visual Acuity Score
timeFrame: Month 24
Secondary outcomes:
measure: Mean Changes in NEI-VFQ-25 Composite Score from Baseline
timeFrame: Month 24, 36
measure: Plasma Concentration of PF-04523655
timeFrame: Week 1
measure: Percent of Subjects Gaining Letters in the Best Corrected Visual Acuity Score from Baseline.
timeFrame: Month 24, 36
measure: Incidence and Severity of Ocular and Systemic Adverse Events, as Identified by Ophthalmic Examination
timeFrame: Month 24, 36
measure: Mean Change from Baseline in the Best Corrected Visual Acuity Score
timeFrame: Month 36
measure: Mean Changes in Area of Fluorescein Leakage from Baseline
timeFrame: Month 24, 36
measure: Percent of Subjects Losing Letters in the Best Corrected Visual Acuity Score from Baseline.
timeFrame: Month 24, 36
measure: Mean Changes in Retinal Thickness from Baseline
timeFrame: Month 24, 36
measure: Mean Changes in Macular Volume from Baseline
timeFrame: Month 24, 36
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Meza
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Peoria
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Mountain View
country: United States
facility: Pfizer Investigational Site
state: California
city: Lakeland
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Winter Haven
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Augusta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Aiea
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: New Albany
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Henderson
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Pfizer Investigational Site
state: Nevada
city: Portsmouth
country: United States
facility: Pfizer Investigational Site
state: New Hampshire
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: High Point
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Statesville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Rapid City
country: United States
facility: Pfizer Investigational Site
state: South Dakota
city: Corpus Christi
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Glostrup
country: Denmark
facility: Pfizer Investigational Site
city: Freiburg
country: Germany
facility: Pfizer Investigational Site
city: Leipzig
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Bhubaneshwar
country: India
facility: Pfizer Investigational Site
state: Orissa
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
city: Bangalore
country: India
facility: Pfizer Investigational Site
city: New Delhi
country: India
facility: Pfizer Investigational Site
city: Kfar Saba
country: Israel
facility: Pfizer Investigational Site
city: Petach - Tikva
country: Israel
facility: Pfizer Investigational Site
city: Tel Aviv
country: Israel
facility: Pfizer Investigational Site
city: Tel Hashomer
country: Israel
facility: Pfizer Investigational Site
city: Zerifin
country: Israel
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Padova
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Udine
country: Italy
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Frimley
country: United Kingdom
facility: Pfizer Investigational Site
state: Camberley, Surrey
city: Bristol
country: United Kingdom
facility: Pfizer Investigational Site
city: Bristol
country: United Kingdom
facility: Pfizer Investigational Site
city: Liverpool
country: United Kingdom
facility: Pfizer Investigational Site
city: Sheffield
country: United Kingdom
facility: Pfizer Investigational Site
city: Southampton
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
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.