Abstract
Purpose:
To evaluate the ocular and systemic safety of intravitreal aflibercept injection (IAI) in patients undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy
Methods:
This was a prospective, open label clinical trial in which 12 patients were enrolled. All patients had nonclearing vitreous hemorrhage (NCVH). All 12 patients received intravitreal Aflibercept 2.0 mg 5 days prior to surgery. 6 patients were randomized to receive an additional intravitreal injection of Aflibercept at the time of surgery. All patients were followed after surgery with visits 1 day, 1 week, 4 weeks, 12 weeks, and 24 weeks postop. Visual acuity in ETDRS letters, IOP, and grading of vitreous hemorrhage following surgery were assessed at each visit.
Results:
Preop VA was 15 ETDRS letters. Intraoperative bleeding was maintained by cautery and IOP control in 2 patients in the IAI single injection group, and IOP control only in 4. The IAI double injection group had 2 cases that needed IOP control, and the rest had no intraoperative bleeding. Postop vitreous hemorrhage grading revealed only two patients in the IAI double injection group that had mild vitreous hemorrhage, the rest had no vitreous hemorrhage 1 week after surgery. The IAI single injection group showed 1 patient with severe postop hemorrhage, 3 with moderate hemorrhage, and only 1 with no hemorrhage at one week. 1 week VA was 55 ETDRS letters in the double injection group at one week compared to 36 letters in the single injection group. At 4 wks, all vitreous hemorrhage had cleared except in 1 patient in the single injection group. VA was 64 ETDRS letters for the double injection group vs. 47 letters for the single injection group at 4 weeks. OCT thickness was 270 microns in the double injection group vs. 305 microns in the single injection at one month, but was essentially the same at 3 months with a central thickness of 265 microns in the double injection group vs. 271 microns in the single injection group. VA at 12 weeks were 62 ETDRS letters in the double injection group vs. 64 letters in the single injection group.
Conclusions:
Intravitreal aflibercept injection was well tolerated in all patients with no serious adverse events reported. Patients who received two injections appeared to have less incidence of intraoperative hemorrhage, less postoperative vitreous hemorrhage, and appeared to clear the hemorrhage faster than the single injection group.
Keywords: 499 diabetic retinopathy •
762 vitreoretinal surgery •
503 drug toxicity/drug effects