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ARTICLE | Clinical News

iCo-007: Phase II data

August 4, 2014 7:00 AM UTC

Top-line data from the physician-sponsored, U.S. Phase II iDEAL trial in 187 Type I or II diabetics with DME showed that all intravitreal injections of 350 and 700 Ug iCo-007 alone and 350 Ug iCo-007 in combination with laser photocoagulation or Lucentis ranibizumab missed the primary endpoint of improving mean visual acuity from baseline to 8 months. Specifically, iCo-00 led to a mean reduction in visual acuity from baseline to month 8 of 11 letters in the 350 Ug monotherapy arm, 21 letters in the 700 Ug monotherapy arm, 14 letters in the 350 Ug plus laser arm and 14 letters in the 350 Ug plus Lucentis arm. At 8 months, the proportion of patients gaining >=5 letters from baseline was about 20% in the 350 Ug monotherapy arm, 13% in the 700 Ug monotherapy arm, 12% in the 350 Ug plus laser arm and 11% in the 350 Ug plus Lucentis arm. At 4 months, the proportion of patients gaining >=5 letters from baseline was about 24% in the 350 Ug monotherapy arm, 18% in the 700 Ug monotherapy arm, 21% in the 350 Ug plus laser arm and 30% in the 350 Ug plus Lucentis arm.

At 8 months, the proportion of patients experiencing a >=15-letter loss in vision from baseline was 33% in the 350 Ug monotherapy arm, 64% in the 700 Ug monotherapy arm, 33% in the 350 Ug plus laser arm and 41% in the 350 Ug plus Lucentis arm. At 4 months, the proportion of patients experiencing a >=15-letter loss in vision from baseline was 9% in the 350 Ug monotherapy arm, 29% in the 700 Ug monotherapy arm, 9% in the 350 Ug plus laser arm and 41% in the 350 Ug plus Lucentis arm. ...