Testing the clinical value of multifocal electroretinography and microperimetry and the effects of intravitreal therapy with ranibizumab on macular function in the course of wet age-related macular degeneration: a 1-year prospective study

Reinsberg, Mihaela; Hilgers, Ralf-Dieter; Lüdeke, Inger; Nassar, Khaled; Grisanti, Swaantje; Grisanti, Salvatore; Lüke, Julia; Lüke, Matthias

doi:10.2147/opth.s123513

Cited by 7 publications

(4 citation statements)

References 42 publications

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“…In the literature, mERG results after anti-VEGF treatment have shown opposing results. MERG results, similar to the outcomes of the present study, have been published previously for other anti-VEGF agents and treatment regimens, and with a shorter follow-up time; after one or three injections of either bevacizumab or ranibizumab [19][20][21], after 6 months with consecutive ranibizumab, bevacizumab or both drugs [6,7,22], and as a 1-year evaluation of continuous treatment with ranibizumab [23,24]. Yet another 12-month study has used a bimonthly aflibercept regimen comparable to arm 1 in the present study [25].…”

Section: Discussionsupporting

confidence: 86%

Electrophysiological evaluation and 18-month follow-up of two regimens with aflibercept for neovascular age-related macular degeneration

2022

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Purpose To compare two aflibercept treatment regimens and the electrophysiological outcome concerning cone and rod function in age-related macular degeneration (nAMD) over 18 months. Methods 41 patients with treatment-naïve nAMD were randomized 1:1 to either arm 1 or 2. Arm 1 received three consecutive monthly aflibercept injections, followed by bimonthly treatment until week 52. Thereafter, a treat-and-extend (TAE) regimen was applied. Arm 2 was treated according to a TAE protocol throughout the 18-month follow-up. We assessed visual acuity (VA), central retinal thickness (CRT), injection rate and interval, and evaluated cone and rod function with full-field and multifocal electroretinography (ffERG, mERG). Results There were no statistically significant differences in mean baseline VA, lesion type, age, gender, or symptom duration between the two arms. During the 18-month follow-up, mean VA improved in arm 1 (n = 19) from 63.5 ± 10.5 to 69.1 ± 9.2 letters; p = 0.098; and in arm 2 (n = 20) from 66.8 ± 13.6 to 73.9 ± 9.0 letters; p = .002. In both arms, mean CRT was significantly reduced; p < 0.000. At month 18, we found no significant difference in the number of injections or injection intervals between groups. Arm 1 had received 11.3 ± 1.7 injections vs. 10.9 ± 2.0 in arm 2. The mean injection interval was 9.2 ± 3.4 weeks vs. 9.5 ± 3.1, with 52% (n = 10) on the maximum 12-week interval in arm 1, and 50% (n = 10) in arm 2. The combined rod-cone a-wave amplitude significantly decreased over time; p = 0.043. The isolated rod b-wave amplitude showed a statistically significant decline; p = 0.026. The overall mERG amplitude and implicit time remained unchanged over time; p = 0.878 vs. p = 0.922. The central ring 1 mERG amplitude improved; p = 0.041, with an unaffected implicit time. Conclusions After 18 months, both treatments arms have received a similar number of injections at comparable intervals. Electrophysiological evaluation shows no signs of toxicity concerning cone function. But ffERGs for the combined and isolated rod response have declined, possibly reflecting either toxic effects of the drug to rods or the natural course of the disease itself.

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Section: Discussionsupporting

confidence: 86%

Electrophysiological evaluation and 18-month follow-up of two regimens with aflibercept for neovascular age-related macular degeneration

2022

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“…There are a small number of publications about microperimetry in DR without macular edema,14 because microperimetry is not a clinical practice test in many countries. However, other macular disorders had been widely studied with microperimetry, for example: age-related macular degeneration,15–20 retinal dystrophies,21–23 myopia24–26 and DME 12,13…”

Section: Discussionmentioning

confidence: 99%

<p>Structure–Function Correlation Using OCT Angiography And Microperimetry In Diabetic Retinopathy</p>

Alonso-Plasencia

Abreu-González

Gomez-Culebras

2019

OPTH

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PurposeTo evaluate macular vasculature in diabetic retinopathy (DR) with optical coherence tomography angiography (OCTA) and to correlate vessel density (VD) with retinal sensitivity (RS) as a way to assess structural and functional findings in DR.DesignProspective observational cross-sectional study.MethodsDiabetic patients with DR but no clinically significant diabetic macular edema (DME) and healthy subjects were included in this study. All of them underwent comprehensive ophthalmic examination, best corrected visual acuity (BCVA), OCTA with RS-3000 Advance AngioScan (Nidek, Gamagori, Japan) and microperimetry with MP-3 (Nidek, Gamagori, Japan). Retinal vascular density measured by OCT angiography in 9 areas was correlated with RS in the same 9 areas by Spearman correlation.ResultsIn this study, 50 subjects were enrolled: 25 eyes of diabetic patients with DR and 25 eyes of non-diabetic subjects. Diabetic patients mean age was 51.88±13.62 years; non-diabetic subjects were 43.48±13.42 years. The BCVA was 20/25 in the diabetic group and 20/20 in the non-diabetic group. Mean RS was decreased in the DR group (27.68±2.71 dB) compared to the non-diabetic group (31.68±1.46 dB) (p<0.05) and in the 9 studied areas (p<0.05). Mean VD was decreased in the DR group compared to non-diabetics (p<0.05) and in 7 of the 9 areas (except temporal superior and inferior squares) (p<0.05). Correlations by areas between VD and RS were assessed, we found moderate correlation in the area temporal to the fovea (r=0.501, p=0.01) in the DR group but not in the non-diabetic subjects. There were no other statistical significant correlations with this pattern.ConclusionDR without DME results in a retinal VD decreased that might be the cause of a reduction of RS in one of the studied areas. Microangiopathic changes are correlated with microperimetry sensitivity drop in the temporal to the fovea grid but not in the other studied grids.

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“…Response densities are known to decrease with age 26 and studies have also shown microstructural and functional progression despite stable morphological features in both non-neovascular and neovascular AMD. 27 , 28 In our present study, many patients—especially the previously treated patients—had developed fibrosis or a macular scar, inhibiting the function of the inner layer. This contributed to a decrease in the intensity of baseline mfERG responses and it would be expected that the use of ranibizumab would have limited efficacy in treating these entities.…”

Section: Discussionmentioning

confidence: 52%

“… 32 However, Reinsberg et al demonstrated that monthly injections with ranibizumab over one year had no statistically significant effects on P1 response density. 28 Over the 12-month enrollment in the study, mfERG results showed retinal health did not improve with either the PRN or monthly ranibizumab injection protocol despite improvements in other endpoints. The mfERG results may prove to be the most sensitive measure of retinal stimulus and reveal loss of structural integrity with chronic nAMD.…”

Section: Discussionmentioning

confidence: 94%

<p>Multifocal ERG and Microperimetry Changes in Response to Ranibizumab Treatment of Neovascular AMD: Randomized Phase 2 Open-Label Study</p>

Asahi

Wallsh

Onishi

et al. 2020

OPTH

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Purpose To compare monthly versus pro re nata (PRN) ranibizumab injections in the treatment of exudative macular degeneration (AMD) while assessing the utility of microperimetry (MP) and multifocal electroretinography (mfERG) testing when monitoring response to treatment. Methods A randomized exploratory trial comparing the efficacy of monthly versus PRN dosing of ranibizumab (0.5 mg or 2.0 mg) for patients with exudative AMD over 12 months. High-resolution optical coherence tomography (HR-OCT) studies were used to guide PRN treatment and any cystic spaces or subretinal fluid prompted retreatment. Macular function was assessed using mean sensitivity on MP and N1-P1 response density on mfERG. Best-corrected visual acuity (BCVA) was measured with Early Treatment Diabetic Retinopathy Study (ETDRS) letters and anatomic response assessed with central foveal thickness (CFT) using HR-OCT studies. Results The 12-month study was completed by 43 patients in the PRN cohort and 33 patients in the monthly cohort. Mean BCVA improved by 6.0 ± 1.3 ETDRS letters in the PRN cohort compared to 7.3 ± 2.8 ETDRS letters in the monthly cohort (p=0.68). A reduction in mean CFT of 64.5 ± 13.3 and 96.3 ± 22.0 µm occurred in the PRN and monthly cohorts, respectively (p=0.22). Macular function assessed with mfERG decreased comparably in both the PRN and monthly cohorts (p=0.33). For all patients, average mean sensitivity significantly improved by 1.7 ± 0.5 dB (p<0.05) and N1-P1 response density significantly decreased by 0.52 ± 0.21 nV/deg 2 (p<0.05). Conclusion Both PRN and monthly treatment of exudative AMD with ranibizumab improve visual function as assessed by BCVA and MP. Macular thickening also improved as demonstrated by HR-OCT findings. However, the decreased retinal function noted by mfERG suggests that some loss of retinal function still occurs despite effective treatment. These measures of visual function may be useful in assessing retinal health and response to treatment in future clinical trials.

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Testing the clinical value of multifocal electroretinography and microperimetry and the effects of intravitreal therapy with ranibizumab on macular function in the course of wet age-related macular degeneration: a 1-year prospective study

Cited by 7 publications

References 42 publications

Electrophysiological evaluation and 18-month follow-up of two regimens with aflibercept for neovascular age-related macular degeneration

Electrophysiological evaluation and 18-month follow-up of two regimens with aflibercept for neovascular age-related macular degeneration

<p>Structure–Function Correlation Using OCT Angiography And Microperimetry In Diabetic Retinopathy</p>

<p>Multifocal ERG and Microperimetry Changes in Response to Ranibizumab Treatment of Neovascular AMD: Randomized Phase 2 Open-Label Study</p>

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