Real-Time Photographic- and Fluorescein Angiographic-Guided Management of Diabetic Retinopathy: Randomized PRIME Trial Outcomes.

摘要: Purpose To assess the safety and efficacy of as-needed (PRN) intravitreal aflibercept injections (IAI) in managing diabetic retinopathy (DR) guided by real-time DR severity scale (DRSS) level or panretinal leakage index (PLI) assessment among eyes without macular edema (DME). Design Prospective, randomized phase 2 trial (PRIME). Methods A total 40 with nonproliferative (NPDR) proliferative (PDR) received monthly IAIs until a DRSS improvement ≥2 steps was achieved were (1:1) to DRSS-guided PLI-guided management strategies graded central reading center. Main outcome measurements included changes PLI. Results Through week 52, 95% steps. Following improvement, 97% required at least 1 PRN IAI. In requiring IAI completing 100% 59% experienced worsening (P = .01) DRSS- arms, respectively. mean PLI decreased 18.2% (P = .49) 54.6% (P Conclusions The PRIME study analyzed imaging-based biomarkers guide DME: Within context this limitations, most patients re-treatment every 3-4 months, deterioration appeared precede worsening. Finally, these findings reaffirm fact that close clinical follow-up is important even achieve substantial improvements apparently quiescent disease.