Double-masked prospective ocular safety study of a lens epithelial cell antibody to prevent posterior capsule opacification.
OBJECTIVE
To evaluate the intraocular safety of an immunoconjugate (MDX-RA) developed to prevent posterior capsule opacification (PCO) in human eyes.


METHODS
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 intracamerally. Two doses of the drug were tested: 8 patients with a low dose (50 units), 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 the Early Treatment of Diabetic Retinopathy Study test, contrast sensitivity, aqueous flare, specular microscopy of the IOL's anterior surface, and corneal endothelial counts. The percentage area of PCO was measured from retroillumination images of the posterior capsule.


RESULTS
There was no decrease in corneal endothelial cell count in toxin-treated patients. Early postoperative flare, anterior chamber cell count, and corneal pachymetry were higher in toxin-treated patients. The median percentage area of PCO at 1 year was 32.0 in the placebo group, 3.8 in the low-dose group, and 7.4 in the high-dose group (P = .06).


CONCLUSIONS
This prospective, randomized, placebo-controlled trial confirmed that MDX-RA is safe for intraocular use and is of potential value for further clinical trials of the prevention of PCO.
Meacock
W R
WR
The Eye Department, St. Thomas' Hospital, London, United Kingdom.
Spalton
D J
DJ
Hollick
E J
EJ
Boyce
J F
JF
Barman
S
S
Sanguinetti
G
G
D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D019923:Capsulorhexis / Q000009:adverse effects; D002386:Cataract / Q000209:etiology / Q000473:pathology / Q000517:prevention & control*; D002452:Cell Count; D004311:Double-Blind Method; D004847:Epithelial Cells / Q000276:immunology / Q000473:pathology; D005260:Female; D006801:Humans; D000922:Immunotoxins / Q000627:therapeutic use*; D007903:Lens Capsule, Crystalline / Q000473:pathology*; D019654:Lens Implantation, Intraocular; D007908:Lens, Crystalline / Q000276:immunology / Q000473:pathology; D008297:Male; D018918:Phacoemulsification / Q000009:adverse effects; D019904:Polymethyl Methacrylate; D011446:Prospective Studies; D012276:Ricin; D012449:Safety
D000911:Antibodies, Monoclonal; D000922:Immunotoxins; D012276:Ricin; D019904:Polymethyl Methacrylate