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Clinical Trials |

Safety and Efficacy Assessment of Chimeric Ribozyme to Proliferating Cell Nuclear Antigen to Prevent Recurrence of Proliferative Vitreoretinopathy

William M. Schiff, MD; John C. Hwang, MD; Michael D. Ober, MD; Jeffrey L. Olson, MD; Elona Dhrami-Gavazi, MD; Gaetano R. Barile, MD; Stanley Chang, MD; Naresh Mandava, MD ; IM-VIT100 Study Group
Arch Ophthalmol. 2007;125(9):1161-1167. doi:10.1001/archopht.125.9.1161.
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Objective  To determine the safety and efficacy of VIT100 (Immusol, Inc, San Diego, California), a ribozyme to proliferating cell nuclear antigen, in preventing recurrent proliferative vitreoretinopathy (PVR) in patients with established PVR who undergo vitrectomy for retinal reattachment repair.

Methods  A multicenter, double-masked, placebo-controlled, randomized clinical trial. One hundred seventy-five eyes from 175 patients with grade C or worse PVR were randomly assigned to receive high-dose VIT100, low-dose VIT100, or placebo by intravitreal injection at the conclusion of retinal reattachment surgery.

Main Outcome Measures  The primary efficacy end point was recurrent retinal detachment secondary to PVR. The secondary end point was recurrent retinal detachment due to any cause.

Results  One hundred fifty-four patients completed the study. Forty-one patients (27%) developed recurrent retinal detachment due to PVR by 24 weeks, including 18 patients (33%) in the group receiving 0.75 mg, 13 patients (24%) in the group receiving 0.15 mg, and 10 patients (22%) in the placebo group. There was no statistically significant difference in patients reaching this end point by 24 weeks (P = .37). Ancillary statistical analyses are reported.

Conclusions  VIT100 was not effective in preventing PVR recurrence in patients with established grade C or worse PVR.

Application to Clinical Practice  To our knowledge, this is the most recent, meticulously designed clinical trial in PVR.

Trial Registration  isrctn.org Identifier: LOCATOR="http://controlled-trials.com/ISRCTN25825250">ISRCTN25825250

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