Efficacy of One-Year Treatment with Aflibercept for Diabetic Macular Edema with Practical Protocol

Abstract

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).

Pharmacological Management of Diabetic Macular Edema in Real-Life Observational Studies

“…Finally, for subgroups with high BVA (>60 letters), there is a mean gain of + 3.1 letters in the anti-VEGF studies [ 16 – 18 , 20 , 22 , 30 , 31 , 34 , 40 – 42 , 44 ] (mean BVA of 65.3 letters) and + 8.8 letters in the DEX-implant studies [ 51 , 59 , 60 , 74 ] (BVA mean of 68.4 letters). Mean follow-up was, respectively, 13.5 months for a mean of 6.5 IVI and 9 months for a mean of 1.8 IVI ( Figure 7 ) ( Table 1 ).…”

Comparisons of One to Three Monthly Injections of Aflibercept for Diabetic Macular Edema by Practical Protocol

“…The medical records of 95 eyes of 71 cases that were diagnosed with DME and had received the first IVA injection at the Chiba University Hospital from January in 2015 to December in 2017 were reviewed. The inclusion criteria were patients with DME who had a vision impairment and a CMT > 250 μ m based on the optical coherence tomographic images (SD-OCT, Heidelberg Engineering, Heidelberg, Germany) [ 19 , 20 , 24 ]. The recent Japanese survey indicates that most ophthalmologists in Japan think OCT findings including CMTs as one of the most important indicators for initial therapeutic intervention [ 24 ].…”

“…Therefore, most Japanese ophthalmologists use OCT findings as the most important assessment indicator [ 24 ]. Eyes with a CMT < 250 μ m, vitreomacular traction, epiretinal membrane, uveitis, glaucoma, and other retinal diseases, with brain or heart ischemia, were excluded [ 19 , 20 , 24 ]. In addition, patients who did not agree to the high cost of frequent IVA injections were excluded [ 19 , 24 ].…”

“…The results of our recent studies of the different injection protocols indicated that as few as 3.8 ± 2.4 anti-VEGF injections can significantly improve the best-corrected visual acuity (BCVA) and the central macular thickness (CMT) in eyes with DME after a one-year treatment period [ 19 ]. In representative clinical trials including the VISTA and the VIVID studies, the mean number of injections was 9-12 times/year.…”

“…In these studies, the injection protocol was 1 to 3 consecutive monthly injections, but if the CMT was >300 μ m, additional injections were given [ 19 , 20 ]. A reduction of the total number of IVA injections is more desirable for the treatment of DME with a practical protocol because it improved the cost effectiveness.…”