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

Phase 2 Terminated 184 enrolled Quark Pharmaceuticals Pfizer · collab

RandomizedParallel-groupSingle-blindTreatment

Summary

To evaluate the effectiveness of study drug in improving visual acuity compared to laser treatment in the patients with diabetic macular edema

Timeline

Start: 2008-06
Primary completion: 2011-01
Completion: 2011-01

Outcome

Missed primary endpoint

Stopped: “See termination reason in detailed description.”

paper PF-04523655 3-mg group showed a trend for greater improvement in BCVA from baseline than laser (respectively 5.77 vs. 2.39 letters; P = 0.08; PMID 23074206 ↗

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PF-04523655	Small interfering RNA (siRNA)	0.4 mg	Intravitreal
Subject	PF-04523655	Small interfering RNA (siRNA)	1 mg	Intravitreal
Subject	PF-04523655	Small interfering RNA (siRNA)	3 mg	Intravitreal