Double-masked prospective ocular safety study of a lens epithelial cell antibody to prevent posterior capsule opacification

Purpose: To evaluate the intraocular safety of an immunoconjugate (MDX-RA) developed to prevent posterior capsule opacification (PCO) in human eyes. Setting: St. Thomas's Hospital Eye Department, London, United Kingdom. Methods: Twenty-six patients had phacoemulsification and implantation of an intraocular lens (IOL). All were randomly allocated at the end of surgery to receive a 0.1 mL placebo or 0.1 mL of the immunotoxin MDX-RA intracamera lly. Two doses of the drug were tested: 8 patients with a low dose (50 unit s), 9 patients with a high dose (100 units), and 9 with placebo. Follow-up at days 1, 14, 30, 60, 90, and 180 consisted of visual acuity measured by t he Early Treatment of Diabetic Retinopathy Study test, contrast sensitivity , aqueous flare, specular microscopy of the IOL's anterior surface, and cor neal endothelial counts. The percentage area of PCO was measured from retro illumination images of the posterior capsule. Results: There was no decrease in corneal endothelial cell count in toxin-t reated patients. Early postoperative flare, anterior chamber cell count, an d corneal pachymetry were higher in toxin-treated patients. The median perc entage area of PCO at 1 year was 32.0 in the group, 3.8 in the low-dose gro up, and 7.4 in the high-dose group (P = .06). Conclusion: This prospective, randomized, placebo-controlled trial confirme d that MDX-RA is safe for intraocular use and is of. potential value for fu rther Clinical trials of the prevention of PCO. J. Cataract Refract Surg 20 00;26:716-721 (C) 2000 ASCRS and ESCRS.