afety Reult of Two Phae III Trial of an Intravitreou Injection of Highly Purified Ovine Hyaluronidae (Vitrae®) for the Management of Vitreou Hemorrhage

Purpoe To evaluate the afety of intravitreou ovine hyaluronidae for the management of vitreou hemorrhage. Deign Two propective, randomized, placebo-controlled, double-maked tudie. Pooled efficacy data are preented in a companion article in thi iue of THE JOURNAL. Method ubject with vitreou hemorrhage ≥1 month, evere at entry and bet corrected viual acuity (BCVA) wore than 20/200 in the tudy eye were randomized to 7.5 IU, 55 IU, 75 IU ovine hyaluronidae, aline, or no injection. Aement occurred on day 1, week 1, month 1, 2, 3, 6, and then every 6 month for a long a 32 month. Aement included hitory, ocular ymptom, advere event, BCVA, intraocular preure, external eye examination, lit-lamp biomicrocopy, fundu examination, B-can ultraonography, and fundu photography. Reult Of 1362 ubject in the afety population, 1344 received hyaluronidae or aline and 18 no treatment. Iriti wa the mot common ocular advere event, occurring in 33.3%, 62.1%, 58.9%, and 62.1% of aline, 7.5 IU, 55 IU, and 75 IU-treated ubject. In eye with more than mild iriti, a doe repone wa oberved: 8.9%, 20.2%, 33.7%, and 39.7% of aline, 7.5 IU, 55 IU, and 75 IU-treated ubject, repectively, were noted to have moderate or evere iriti. Retinal detachment (RD) were reported in 9.5% of tudy eye: 26 (6.9%), 22 (11.1%), 35 (9.3%), and 45 (11.5%) in the aline, 7.5 IU, 55 IU, and 75 IU-treated ubject. Overall, 1.8% of tudy eye had rhegmatogenou RD: 1.1%, 2.5%, 1.6%, and 2.3% of aline, 7.5, 55, and 75 IU treated ubject. Cataract occurred imilarly acro treatment group. No injection-related infectiou endophthalmiti wa reported. Concluion No eriou afety iue were reported after a ingle intravitreou injection of ovine hyaluronidae. RD incidence wa not tatitically different between group. Iriti manifeting a an acute elf limited inflammation wa the mot common advere event, occurred in a doe repone fahion, but wa not noted to reult in a eriou advere event in any hyaluronidae treated eye.