Randomized clinical trial comparing intravitreal aflibercept combined with subthreshold laser to intravitreal aflibercept monotherapy for diabetic macular edema

Tatsumi, Tetsuya; Takatsuna, Yoko; Oshitari, Toshiyuki; Kaiho, Tomomi; Kawasaki, Yohei; Shiko, Yuki; Sugawara, Takeshi; Baba, Takayuki; Yamamoto, Shuichi

doi:10.1038/s41598-022-14444-y

Cited by 7 publications

(13 citation statements)

References 44 publications

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Section: Clinical Applicationsmentioning

confidence: 99%

“…The mean follow-up of the studies shown ranged between 6 and 24 months [ 55 – 64 ]. Most of the studies reported indicated a common positive result for the usefulness of YSML, which appeared to have complimentary effects to the anti-VEGF therapy [ 55 – 64 ]. Their combined use was demonstrated, in fact, to significantly reduce the number of anti-VEGF injections while preserving or even improving morpho-functional outcomes.…”

Section: Clinical Applicationsmentioning

confidence: 99%

“…Their combined use was demonstrated, in fact, to significantly reduce the number of anti-VEGF injections while preserving or even improving morpho-functional outcomes. BCVA improvement and a CMT decrease were illustrated in two thirds [ 55 , 56 , 58 – 61 , 63 ] and in half of the studies considered [ 55 , 58 – 61 ], respectively, and a stabilization of these features was described in the remaining cases throughout the entire follow-up [ 56 , 57 , 62 – 64 ].…”

Section: Clinical Applicationsmentioning

confidence: 99%

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Yellow Subthreshold Micropulse Laser in Retinal Diseases: An In-Depth Analysis and Review of the Literature

et al. 2023

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Yellow subthreshold micropulse laser (YSML) is a retinal laser capable of inducing a biologic response without causing thermal damage to the targeted tissue. The 577-nm YSML is delivered to the retina abiding by different protocols in which wavelength, power, duration, spot size and number of spots can be properly set to achieve the most effective and safe treatment response in various chorioretinal disorders. The ultrashort trains of power modulate the activation of the retinal pigment epithelium cells and intraretinal cells, such as Müller cells, causing no visible retinal scars. Subthreshold energy delivered by YSML stimulates the production of the heat-shock proteins, highly conserved molecules that protect cells against any sort of stress by blocking apoptotic and inflammatory pathways that cause cell damage. YSML treatment allows resorption of the subretinal fluid in central serous chorioretinopathy and intraretinal fluid in various conditions including diabetic macular edema, postoperative cystoid macular edema and other miscellaneous conditions. YSML also seems to modulate the development and progression of reticular pseudodrusen in dry age-related macular degeneration. The aim of this review is to discuss and summarize the safety and efficacy of YSML treatment in retinal diseases.

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Section: Clinical Applicationsmentioning

confidence: 99%

Section: Clinical Applicationsmentioning

confidence: 99%

Section: Clinical Applicationsmentioning

confidence: 99%

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Yellow Subthreshold Micropulse Laser in Retinal Diseases: An In-Depth Analysis and Review of the Literature

et al. 2023

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“…Thirty full-text articles were reviewed to determine whether they met the inclusion criteria. Eventually, 13 articles were included in the NMA ( Figure 1 ) ( 14 , 18 , 24 – 34 ). Characteristics of all the included RCTs are summarized in Table 1 .…”

Section: Resultsmentioning

confidence: 99%

“…Additionally, the effectiveness of LP may be improved by LP becoming easier because of the reduction in macular edema caused by anti-VEGF injections. Several studies have evaluated LP as an adjunctive treatment for anti-VEGF agents; however, their conclusions are inconsistent (13)(14)(15)(16)(17)(18).…”

Section: Introductionmentioning

confidence: 99%

Intravitreal anti-vascular endothelial growth factor, laser photocoagulation, or combined therapy for diabetic macular edema: A systematic review and network meta-analysis

2023

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PurposeTo conduct a network meta-analysis (NMA) comparing the efficacy of anti-vascular endothelial growth factor (VEGF) therapy alone versus laser photocoagulation (LP) therapy alone or anti-VEGF therapy combined with LP therapy for diabetic macular edema (DME).MethodsPubMed, Embase, Web of Science, and Cochrane Central Register of Controlled Trials were systematically searched for studies comparing anti-VEGF therapy alone versus LP therapy alone or anti-VEGF therapy combined with LP therapy for DME. Primary outcomes were mean best-corrected visual acuity (BCVA) and central macular thickness (CMT) change. Relevant data were collected and pooled using NMA.ResultsA total of 13 randomized controlled trials were included in our NMA. Anti-VEGF therapy significantly improved BCVA the most compared to the combined (mean difference [MD] = 1.5; 95% confidence interval [CI]: 0.084, 2.7) and LP (MD = 6.3; 95% CI: 5.1, 7.6) therapies at six months, while there was no difference in reducing CMT at six months between the anti-VEGF and combined therapies (MD = -16; 95% CI: -46, 13). At 12 months, no significant difference was found between the anti-VEGF and combined therapy in terms of BCVA (MD = 0.1; 95% CI: -1.7, 1.5) and CMT (MD = 21; 95% CI: -3.0, 44).ConclusionThere was no significant difference between the anti-VEGF therapy and combined therapy. For the long-term treatment of patients with DME, combined therapy is recommended.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD42022376401.

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Efficacy of anti-VEGF monotherapy versus anti-VEGF therapy with subthreshold micropulse laser (SML) in the management of diabetic macular oedema (DMO): a systematic review and meta-analysis

Wijeweera,

Ni,

Petocz

et al. 2024

Graefes Arch Clin Exp Ophthalmol

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Background Intravitreal injection anti-vascular endothelial growth factor (IVI anti-VEGF) therapy serves as the primary treatment for centre involving diabetic macular oedema (DMO). Conventional laser therapy (CLT) adjunct has proven beneficial; however, it is not widely used due to significant risks of retinal scarring. Subthreshold micropulse laser (SML) therapy has, however, emerged as a comparable alternative to combination therapy, offering a distinct advantage by mitigating the risk of retinal scarring. Methods A search of six databases was conducted. A meta-analysis of mean differences was performed including subgroup analyses where appropriate. Primary outcome was the number of injections at 12–14 months; secondary outcomes were changes in central macular thickness (CMT) and best corrected visual acuity (BCVA) at 6–8 months and 12–14 months. Results A total of ten papers including six randomised clinical trials and four retrospective clinical studies were included in our study, capturing 563 eyes of 478 patients. Overall, the risk of bias was moderate for these studies. Significantly fewer anti-VEGF therapy injections were administered in the combination therapy versus anti-VEGF monotherapy patients at 12–14 months who had poor visual acuity (6/18 Snellen or worse) at baseline, mean difference − 2.25 (95% CI; − 3.35, − 1.15; p < 0.05). Combination therapy was not associated with significantly fewer intravitreal injections in patients with a higher visual acuity (6/15 Snellen or better) at baseline. Our analysis also showed significant improvements to both BCVA and CMT were reached at 6 − 8 month post-baseline at the 95% confidence intervals: − 1.13 (− 2.09, − 0.16) and − 4.04 (− 7.59, − 0.50). These improvements remained statistically significant at 12–14 months: − 0.94 (− 1.67, − 0.20) and − 1.92 (− 3.52, − 0.32) respectively with combination therapy. Conclusion Our findings demonstrate that combination therapy (SML + IVI anti-VEGF) is associated with fewer intravitreal injections. We report a better BCVA and a reduction in CMT at 6 and 12 months from baseline with combination treatment compared to the IVI anti-VEGF monotherapy comparator. SML is a proven non-scarring cost-effective therapy for DMO that should be readily available in the medical retinal therapy as it may reduce the burden of care.

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Randomized clinical trial comparing intravitreal aflibercept combined with subthreshold laser to intravitreal aflibercept monotherapy for diabetic macular edema

Cited by 7 publications

References 44 publications

Yellow Subthreshold Micropulse Laser in Retinal Diseases: An In-Depth Analysis and Review of the Literature

Yellow Subthreshold Micropulse Laser in Retinal Diseases: An In-Depth Analysis and Review of the Literature

Intravitreal anti-vascular endothelial growth factor, laser photocoagulation, or combined therapy for diabetic macular edema: A systematic review and network meta-analysis

Efficacy of anti-VEGF monotherapy versus anti-VEGF therapy with subthreshold micropulse laser (SML) in the management of diabetic macular oedema (DMO): a systematic review and meta-analysis

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