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

Sponsor:	Quark Pharmaceuticals
Collaborator:	Pfizer
Information provided by (Responsible Party):	Quark Pharmaceuticals
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 Diabetes Complications	Procedure: Laser Treatment Drug: PF-04523655 high Drug: PF-04523655 middle Drug: PF-04523655 low	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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)

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Diabetes Complications Diabetic Eye Problems Edema Retinal Disorders

U.S. FDA Resources

Further study details as provided by Quark Pharmaceuticals:

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 ]

Enrollment:	184
Study Start Date:	June 2008
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

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

Show 53 Study Locations

Sponsors and Collaborators

Quark Pharmaceuticals

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Quark Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00701181 History of Changes
Other Study ID Numbers:	B0451004
Study First Received:	June 17, 2008
Last Updated:	October 28, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Quark Pharmaceuticals:

Phase II
Prospective
Randomized

Diabetic Macular Edema
PF-04523655
Laser

Additional relevant MeSH terms:

Diabetic Retinopathy
Edema
Macular Edema
Retinal Diseases
Diabetes Complications
Eye Diseases
Diabetic Angiopathies

Vascular Diseases
Cardiovascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration

ClinicalTrials.gov processed this record on February 09, 2012