Título

PREVENTION OF MACULAR EDEMA IN PATIENTS WITH DIABETIC RETINOPATHY UNDERGOING CATARACT SURGERY: THE PROMISE TRIAL

Objetivo

To determine the safety and efficacy of intravitreal aflibercept injection (IAI) in patients with diabetic retinopathy (DR) in the prevention of macular edema following cataract surgery.

Método

Design: Phase II, prospective, interventional, single-masked randomized trial at a single center Subjects: There were 30 patients ≥ 18 years of age with non-proliferative diabetic retinopathy and undergoing cataract surgery Methods: 2 mg intravitreal aflibercept (0.05 mL) or sham injection during cataract surgery. Main Outcome Measures: Treatment adverse events, best-corrected visual acuity (BCVA), and incidence of macular edema, which is defined as one of the following: presence of cystoid abnormalities as detected by OCT at any follow-up visit, ≥ 30% increase from pre-operative baseline in central subfield macular thickness, or BCVA decrease of >5 E-ETDRS letters from day 7 due to retinal thickening.

Resultado

There were similar incidences of adverse events between the two groups and no clinically serious ocular adverse events in either group. The IAI group had fewer ME events at Day 14 (13% vs. 53%, p=0.022), but there was no significant difference in ME events at Day 30 (27% vs. 60%, p=0.057), Day 60 (27% vs. 60%, p=0.057), or Day 90 (40% vs. 67%, p=0.161). The IAI group had smaller increases in CST at Day 30 (7.95 μm vs. 50.05 μm, p=0.040) and Day 60 (3.02 μm vs. 56.45 μm, p=0.010), but not at Day 90 (18.48 μm vs. 50.31 μm, p=0.12). There were no significant differences in BCVA gains between the IAI and sham group at the end of the follow-up period (Day 90, ETDRS letters: 9.88 vs. 1.36, p=0.66).

Conclusão

Use of IAI in patients with DR for prevention of ME following cataract surgery showed no significant adverse events. While there were significant differences in macular edema incidence and retinal thickness at periods of time, there was no clinically meaningful benefit in terms of visual acuity. Further larger trials are needed to validate these findings.