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

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.

• Laser Treatment (Procedure): Necessity of laser treatment is assessed every three months.
• PF-04523655 high (Drug): 3 mg intravitreal injection
• PF-04523655 middle (Drug): 1 mg intravitreal injection
• PF-04523655 low (Drug): 0.4 mg intravitreal injection

Primary outcomes

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

Secondary outcomes

• 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]

Sex: All, ages: 18 Years to any

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.

• Results publication: 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. PMID 23074206

• Pfizer CT.gov Call Center, Study director, Pfizer