The purpose of this study was to determine the efficacy of one-year treatment of diabetic macular edema (DME) with intravitreal aflibercept (IVA) injections on a practical protocol. The medical records of 51 eyes of 43 patients who were diagnosed with DME and had received IVA treatments were reviewed. The best-corrected visual acuity (BCVA) and the central macular thickness (CMT) were measured at the baseline and at 1, 3, 6, and 12 months after the IVA. The mean number of IVA injections was 3.8 ± 2.4. The mean BCVA was significantly better and the CMT was thinner after the IVA at all follow-up times (P < 0.05). The BCVA was better in eyes with a serous retinal detachment (SRD) than without a SRD (P < 0.01). There was a significant correlation between the photoreceptor outer segment (PROS) length and BCVA at the baseline and at 12 months after the IVA (P < 0.05). A fewer number of IVA injections significantly improved the BCVA and the CMT in eyes with DME after one-year treatment. IVA was more effective in the SRD+ group than in the SRD− group. The PROS length may be a predictive marker for visual outcomes after one-year treatment with IVA for DME (IRB#2272).
The purpose of this study was to compare the efficacies of one initial intravitreal injection of aflibercept followed by a pro re nata (PRN; 1+PRN) regimen to those of three consecutive monthly injections followed by the PRN (3+PRN) regimen for diabetic macular edema (DME) with practical protocols. The medical records of 95 eyes of 71 cases that were diagnosed with DME and had received intravitreal aflibercept (IVA) injections were reviewed. Fifty-seven eyes had received IVA with the 1+PRN regimen, and 38 eyes had received IVA with the 3+PRN regimen. The best-corrected visual acuity (BCVA) and the central macular thickness (CMT) were measured at the baseline and at 1, 3, 6, and 12 months after the IVA. The mean number of injections of the 1+PRN group was 2.9 ± 1.7 , which was significantly fewer than that of the 3+PRN group at 4.6 ± 1.4 ( P < 0.001 ). The change of the mean BCVA before and after the IVA at 12 months of the 3+PRN group was − 0.14 ± 0.17 logMAR units which was significantly better than that of the 1+PRN group of − 0.045 ± 0.25 logMAR units ( P = 0.02 ). The change of the CMT before and after the IVA at 6 months of the 3+PRN group was − 141.3 ± 152.4 μ m which was significantly more than that of the 1+PRN group at − 86.1 ± 117.8 μ m ( P = 0.013 ). Although the mean number of injections was more than that in the 1+PRN regimen, the 3+PRN regimen had better visual outcomes at 12 months. In a practical protocol, we recommend the 3+PRN regimen for patients with DME (IRB#3541).
To compare the efficacy and safety of intravitreal aflibercept with three loading doses + pro re nata regimen combined with subthreshold laser application to that of IVA monotherapy on eyes with diabetic macular edema. This was a phase 4 clinical trial with a prospective, randomized, and parallel investigator-driven protocol. Patients with DME were randomly assigned to the IVA monotherapy group (n = 25) or the IVA + SL combination therapy group (n = 26). The main outcome measures were the number of IVA injections and the changes in the best-corrected visual acuity (BCVA) and the central retinal thickness (CRT) at the final evaluation at 96 weeks. The mean number of IVA injections in the monotherapy group was 5.86 ± 2.43 and it was 6.05 ± 2.73 in the IVA + SL group at 96 weeks, and this difference was not significant (P = 0.83). The differences in the mean changes of the CRT (P = 0.17) and the BCVA (P = 0.31) were also not significant between the two groups throughout the follow-up period. We conclude that adjunct of SL to anti-VEGF therapy does not reduce the number of necessary intravitreal injections.
A 61-year-old Japanese woman presented with impairment of her left vision due to macular schisis secondary to branch retinal vein occlusion. Her left vision was 20/50, and schisis was observed inferotemporally. She underwent phacoemulsification and aspiration, implantation of the intraocular lens, and removal of the epiretinal membrane and internal limiting membrane. Her visual acuity stabilized ~20/50 for two and a half years after the initial surgery. However, she developed macula-involving retinal detachment, and her visual acuity declined to counting fingers. She underwent pars plana vitrectomy and removal of the residual vitreous cortex together with the inner retina within the area of vein occlusion. After the removal of silicone oil and the addition of an encircling buckle, the retina remained attached and visual acuity improved to 20/60 at one year after the final surgery. The combination of rhegmatogenous and tractional detachment in the area of schisis was suspected, and vitrectomy with inner retinectomy was effective.
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