Author: Yusuke Koga (Japan)
Co-authors: Kentaro Kojima, Yohei Otsuki, Natsuki Kusada, Chie Sotozono
Purpose
Retinal vein occlusion (RVO) is the second-leading cause of retinal vascular disease-related vision loss. The most common cause of visual loss in RVO patients is macular edema (ME). Recently, anti-vascular endothelial growth factor (anti-VEGF) therapy has been the standard treatment for RVO-related ME. The VIBRANT Study investigated the effect of anti-VEGF therapy on ME with branch retinal vein occlusion (BRVO), and the GALILEO Study investigated the effect of anti-VEGF therapy on ME with central retinal vein occlusion (CRVO). The findings in these large-scale, prospective, randomized clinical trial studies revealed the effectiveness of anti-VEGF treatment, however, the visual acuity (VA) of the patients before treatment in the studies was 20/40 or less. Thus, the purpose of this prospective observational study is to investigate the effects of intravitreal aflibercept (IVA) injections for BRVO and CRVO patients with a VA of better than 20/40.
Setting/Venue
Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Methods
In this prospective observational study, untreated BRVO and CRVO patients with ME and a 20/40 or better VA were enrolled. We excluded the following patients: those with a history of laser therapy, other ocular surgery, topical steroid treatment or other anti-VEGF therapy; those with uncontrolled glaucoma; those with uncontrolled hypertension; and/or those with pathology of other retinal disorders that affect visual acuity. After obtaining written informed consent, the patients received IVA injections with a 'treat-and-extend' regimen. The primary endpoints were retinal sensitivity (RS) at central 4 degrees measured with microperimetry (MP-1) and best-collected visual acuity (BCVA) at 12-months post treatment. The secondary endpoints were central retinal thickness (CRT) measured by optical coherence tomography (OCT) and the mean deviation (MD) value of Humphrey 30-2 visual field analyzer (HFA) findings at 12-months post treatment.
Results
Thirty-seven eyes of 37 BRVO patients and 15 eyes of 15 CRVO patients were enrolled. Of those, 35 BRVO patients and 14 CRVO patients completed the study. In the BRVO group and CRVO group, from pre-treatment to at 12-months post therapy, mean RS significantly improved from 8.75±3.32 dB to 11.6±3.08 dB and from 6.30±3.49 dB to 10.59±4.68 dB, respectively (P<0.05), mean BCVA (logMAR) significantly improved from 0.19±0.12 to 0.06±0.16 µm (P<0.005) and from 0.15±0.13 to 0.07±0.16 (P=0.0805), respectively, thus showing no significant improvement in the CRVO patients, CRT significantly decreased from 402±116 µm to 245±51.1 µm (P<0.0001) and from 397±135 µm to 237±70.0 µm (P<0.005), respectively, and the MD values HFA changed from -4.5±3.4 dB to -4.5±4.4 dB (P=0.8619) and from -2.9±2.1 dB to -3.2±3.1 dB (P=0.8777), respectively, thus illustrating no significant change in both groups. In the BRVO and CRVO groups, the mean number of IVA injections was 5.9±1.6 and 5.4±1.1, respectively. Two BRVO patients and 1 CRVO patient were dropped out of the study. In the BRVO group, 1 patient developed endophthalmitis and treatment in 1 patient was interrupted. In the CRVO group, branch retinal artery occlusion developed in 1 patient.
Conlusions
Anti-VEGF therapy was found effective for treating RVO-related ME patients with a VA of 20/40 or better.
Financial Disclosure
This study is an investigator-initiated clinical study conducted with finantial support from Bayer Yakuhin, Ltd. kojima k: Santen Pharmaceutical Co. Ltd., lecture fee sotozono c: Santen Pharmaceutical Co. Ltd., finantial support
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