Abstract
Purpose :
Proliferative diabetic retinopathy (PDR) is a potentially blindness-inducing complication of diabetes that affects 17 million persons worldwide. Since the 1980s, pan-retinal photocoagulation (PRP) has been the reference treatment, but its side effects involve loss of the peripheral field of vision. The main objective of this study was to evaluate neovascularisation regression by means of anti-VEGF intravitreal injections (IVI) of aflibercept (EYLEA®) in uncomplicated proliferative diabetic retinopathy at 12 months.
Methods :
Phase II, interventional, prospective, open-label, multicenter pilot study. Randomized into 2 arms (PRP or IVI group) and monitored for 18 months. Participants had type 1 or type 2 diabetes with uncomplicated proliferative diabetic retinopathy, excluding macular oedema greater than 350 µm. As regards the examination, visual acuity assessment was carried out using an ETDRS Log-MAR scale at 4 meters, optical coherence tomography (OCT) for retinal thickness, OCT angiography for the foveal avascular zone (FAZ) and fluoresceine angiography (Spectralis HEIDELBERG) for surface area measurement.
Results :
A total of 40 patients were randomized to the 2 groups between May 2014 and August 2018. As regards the primary endpoint, there was a significant difference, with neovessel regression exceeding 50% in 88.9% of the IVI group at 12 months, compared with 26.3% in the PRP group (p = 0.0002). As regards variation in macular retinal thickness, the 12-month test was likewise significant, with a mean reduction of 20.8 µm in the IVI group versus a mean increase of 16.9 µm in the PRP group (p = 0.0004). There was no significant difference concerning best corrected visual acuity, area of the foveal avascular zone or non-perfusion index.
Conclusions :
The study showed greater regression of neovascularisation at 12 months with intravitreal aflibercept compared to PRP in treatment of proliferative diabetic retinopathy. No significant difference in visual acuity gain appeared. Our study is in line with the S Protocol by Gross (2015, JAMA) and the CLARITY study by Sivaprasad (2017, LANCET). However, instead of focusing on visual acuity, the primary endpoint here is neovessel regression on angiography, showing superior efficacy of IVTs that become a valid alternative to RRP and its adverse effects.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.