Safety and efficacy assessment of chimeric ribozyme to proliferating cell nuclear antigen to prevent recurrence of proliferative vitreoretinopathy

Arch Ophthalmol. 2007 Sep;125(9):1161-7. doi: 10.1001/archopht.125.9.1161.


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.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Double-Blind Method
  • Female
  • Humans
  • Injections
  • Intraocular Pressure
  • Male
  • Middle Aged
  • Proliferating Cell Nuclear Antigen / genetics*
  • Prospective Studies
  • RNA, Catalytic / administration & dosage*
  • RNA, Catalytic / adverse effects
  • RNA, Messenger / genetics
  • Recombinant Fusion Proteins / administration & dosage
  • Recombinant Fusion Proteins / adverse effects
  • Retinal Detachment / prevention & control
  • Retinal Detachment / surgery
  • Scleral Buckling
  • Secondary Prevention
  • Treatment Outcome
  • Visual Acuity
  • Vitrectomy
  • Vitreoretinopathy, Proliferative / prevention & control*
  • Vitreous Body


  • Proliferating Cell Nuclear Antigen
  • RNA, Catalytic
  • RNA, Messenger
  • Recombinant Fusion Proteins

Associated data

  • ISRCTN/ISRCTN25825250