Evaluation of microaneurysms as predictors of therapeutic response to anti-VEGF therapy in patients with DME

Hatano, Makoto; Higashijima, Fumiaki; Yoshimoto, Takuya; Ogata, Tadahiko; Ohta, Manami; Kobayashi, Yohnosuke; Wakuta, Makiko; Yanai, Ryoji; Kimura, Kazuhiro

doi:10.1371/journal.pone.0277920

Cited by 6 publications

(4 citation statements)

References 36 publications

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“…Indeed, increased CST was more frequently observed around microaneurysms 16 nd a recent analysis published in literature demonstrated that the use of anti-VEGF decreased the numbers of microaneurysms in patients with DME. 7 We demonstrate in the current analysis that the numbers of microaneurysms was halved by the end of the follow-up period, probably explaining the sustained anatomical response to the molecule. The same conclusions can be drawn with hard exudate quanti cation which showed a signi cant decrease in surface area between baseline and the end of follow-up.…”

Section: Discussionmentioning

confidence: 49%

“…The primary outcome measure was the change in BCVA at 12 months. Secondary outcome measures were the proportion of patients who gained ≥ 15 letters from baseline to month 12, CST changes at 12 months, the change in microaneurysms numbers from baseline to 12 months counted on early, and late phases of uorescein angiography as previously described, 7 and the change in hard exudates area on fundus retinography using ImageJ (available in the public domain at https://imagej.nih.gov/ij/download.html Institute of Health, USA) according to the algorithm previously described. 8 Ocular hypertension (OHT) was de ned as IOP > 25 mmHg and/or an increase of 10 mmHg from baseline over the follow-up period.…”

Section: Outcome Measuresmentioning

confidence: 99%

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: Pro Re Nata brolucizumab for early onset and treatment-naïve diabetic macular edema: a prospective study

Bilgic¹,

Kodjikian²,

González-Cortés³

et al. 2023

Preprint

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OBJECTIVES To determine the efficacy and safety of brolucizumab therapy administered on a pro re nata (PRN) basis without loading dose in treatment naïve patients with diabetic macular edema (DME) for 1 year follow-up. METHODS Patients with recent DME (< 6 months) received a mandatory brolucizumab injection at inclusion and other injections could be given on a PRN basis with an 8-week interval (between injections) at minimum. Rescue therapy with other anti-VEGF was possible in case of incomplete DME resolution after the second brolucizumab and with a minimum of 1-month treatment free interval between 2 injections. The primary outcome measure was the change in best-corrected visual acuity (BCVA) at 12 months. Secondary outcome measures included the change in central subfield thickness (CST), the change in hard exudate surface area and microaneurysms at 1 year. RESULTS A total of 53 patients were included. At 12 months, the mean (SD) number of injections was 2.6 (0.8) in addition to the first mandatory injection. The mean (SD) interval between 2 consecutive injections was 3.2 (1.4) months. The mean (SD) BCVA improved from 0.62 (0.1) logMAR to 0.40 (0.16) logMAR (p = 0.012). The mean CST reduced from 397.0 (47.2) µm to 224.5 (28.1) µm (p = 0.013). The hard exudate surface area decreased significantly (p = 0.012) as did the number of microaneurysms (p = 0.02). Seven patients required at least 1 rescue therapy and no patients experienced intra-ocular inflammatory adverse events. CONCLUSION Brolucizumab therapy for DME is a safe and effective modality for the treatment of recent DME and has the potential to reduce the number of injections.

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Section: Discussionmentioning

confidence: 49%

Section: Outcome Measuresmentioning

confidence: 99%

: Pro Re Nata brolucizumab for early onset and treatment-naïve diabetic macular edema: a prospective study

Bilgic¹,

Kodjikian²,

González-Cortés³

et al. 2023

Preprint

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“…Makoto Hatano et al demonstrated that detection of MAs in the nasal macula using pretreatment indocyanine green angiography may indicate resistance to anti-VEGF therapy in DME patients. The presence of large MAs in the nasal macula indicates that the DME condition is physiologically and anatomically severe, and such cases are likely to resist anti-VEGF therapy [ 24 ].…”

Section: Discussionmentioning

confidence: 99%

Real-World Outcomes of a Loading Phase with Intravitreal Faricimab in Neovascular Age-Related Macular Degeneration (n-AMD) and Diabetic Macular Edema (DME)

Giancipoli,

Guglielmi,

Bux

et al. 2024

Ophthalmol Ther

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Introduction The aims of this work were to evaluate the real-world efficacy and safety of a loading dose of intravitreal faricimab in eyes with active neovascular age-related macular degeneration (n-AMD) or diabetic macular edema (DME) and to analyze the treatment outcome in relation to specific biomarkers. Methods Patients with active n-AMD or DME, treated with four monthly intravitreal injections of faricimab, were enrolled in this retrospective, uncontrolled study. Best-corrected visual acuity (BCVA), central subfield thickness (CST), presence of retinal fluid (RF) on optical coherence tomography (OCT), and adverse events were assessed at baseline and at weeks 4, 8, 12, and 16. Predefined biomarkers were evaluated at baseline (BL) and at last visit. Results Sixteen eyes of 15 patients with n-AMD (n-AMD group) and 15 eyes of 12 patients with DME (DME group) were included. Mean (± standard deviation) logarithm of minimum angle of resolution (logMAR) BL BCVA changed from 0.68 (± 0.43) to 0.53 (± 0.36; P = 0.13) and from 0.51 (± 0.34) to 0.32 (± 0.24; P : 0.048) at week 16 in n-AMD and DME group, respectively. A statistically significant mean CST reduction was reported in both groups at last visit (n-AMD: − 166.5 μm; P = 0.0009/DME: − 110.8 μm; P = 0.0086). Seventy-five and 33% of eyes with n-AMD and DME respectively achieved complete RF resolution at last visit. Subfoveal inner and outer retinal damage correlated with a lower final BCVA in n-AMD group. The presence of large (> 100 μm) juxtafoveal microaneurysms (MAs) was significantly correlated with a higher chance of residual fluid in eyes with DME. Conclusions Both n-AMD and DME groups achieved satisfactory anatomical results after a loading-dose of intravitreal faricimab. BCVA improvement might be hampered by pre-existing retinal damage in eyes with n-AMD. Large, juxtafoveal MAs might represent a hallmark of a slower anatomical response to the treatment in eyes with DME.

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“…However, the evaluation of MAs pre-and post-anti-EGF therapy may have clinical implications for decision making. Hanato M et al, using indocyanine green angiography (IA), found that non-responders to anti-VEGF therapy had a higher number of pre-treatment nasal macular MAs [44]. Additionally, Mori et al found that the number of MAs in late-phase IA at baseline and at six months was significantly higher in patients who had a recurrence of DME after treatment [45].…”

Section: Vd Changes During Dme Treatmentmentioning

confidence: 99%

Correlation between Topographic Vessel Density and Retinal Thickness Changes in Patients with Diabetic Macular Edema Treated with Anti-VEGF Therapy: Is It a Suitable OCTA Biomarker?

Santamaría,

Caminal,

Cobos

et al. 2023

JPM

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The objective of this study was to determine the correlation between topographic vessel density (VD) and retinal thickness (RT) reductions induced by vascular endothelial growth factor inhibitors (anti-VEGF) in patients with diabetic macular edema (DME) using optical coherence tomography angiography (OCTA). This was a prospective, interventional case series. VD and RT measurements were separately taken in four parafoveal subfields at baseline and after six months of treatment. This correlation was statistically assessed using Spearman’s rho correlation coefficient after adjustment for multiple comparisons. The study included a total of 48 eyes in the final analysis. Mean VD decreased from baseline to month 6 (from 45.2 (±3.5) to 44.6% (±3.2) in the superficial capillary plexus and from 50 (±3.3) to 49% (±3.9) in the deep capillary plexus). Statistically significant reductions in RT were observed in all ETDRS sectors (p < 0.0001). No significant association was found between RT and VD, even when analyzing responders and non-responders separately. After six months of anti-VEGF treatment, no significant correlation was observed between the topographic VD and RT values. These findings suggest that reductions in VD values may not solely result from a reduction in microaneurysms, also being affected by the repositioning of displaced vessels due to edema and a reduction in their caliber. Therefore, VD changes may not be a suitable indirect OCTA biomarker of microaneurysm turnover and treatment response.

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Evaluation of microaneurysms as predictors of therapeutic response to anti-VEGF therapy in patients with DME

Cited by 6 publications

References 36 publications

: Pro Re Nata brolucizumab for early onset and treatment-naïve diabetic macular edema: a prospective study

: Pro Re Nata brolucizumab for early onset and treatment-naïve diabetic macular edema: a prospective study

Real-World Outcomes of a Loading Phase with Intravitreal Faricimab in Neovascular Age-Related Macular Degeneration (n-AMD) and Diabetic Macular Edema (DME)

Correlation between Topographic Vessel Density and Retinal Thickness Changes in Patients with Diabetic Macular Edema Treated with Anti-VEGF Therapy: Is It a Suitable OCTA Biomarker?

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