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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Type :	Interventional (Clinical Trial)
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 :	June 2008
Actual Primary Completion Date :	January 2011
Actual Study Completion Date :	January 2011

Arms and Interventions

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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

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Primary Outcome Measures :

1. Mean Change from Baseline in the Best Corrected Visual Acuity Score [ Time Frame: Month 24 ]

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 53 Study Locations

Sponsors and Collaborators

Quark Pharmaceuticals

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Quark Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00701181 History of Changes
Other Study ID Numbers:	B0451004
First Posted:	June 19, 2008
Last Update Posted:	October 11, 2012
Last Verified:	October 2012

Keywords provided by Quark Pharmaceuticals:

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

Additional relevant MeSH terms:

Macular Edema; Diabetic Retinopathy; Diabetes Complications; Macular Degeneration; Retinal Degeneration; Retinal Diseases	Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Endocrine System Diseases