Abstract:Background
The DRCR.net Protocol T clinical trial assessed the comparative efficacy and safety of anti-VEGF treatments including aflibercept, ranibizumab and bevacizumab in diabetic macular edema (DME). Post -hoc analyses showed that after a 12-week induction period, there was still DME resolution in an increasing number of patients through week 24.
Purpose
To assess clinical and cost consequences of extending the anti-VEGF loading dose from 3 to 6 monthly injections in patients with persistent DME in Spain.… Show more
“…In a previous paper published by our group, we evaluated the cost of extending the anti-VEGF treatment from 3 to 6 monthly injections [ 25 ]. This study revealed the incremental costs of extending the anti-VEGF dose in central-involved DME patients who initially did not respond adequately to treatment.…”
Section: Discussionmentioning
confidence: 99%
“…“Not-adequately” respond to anti-VEGF was defined if after 3 anti-VEGF injections (either ranibizumab, bevacizumab, or aflibercept), there was (1) no improvement in best corrected visual acuity (BCVA) and/or (2) a central retinal thickness (CRT) reduction < 20% and/or (3) recurrence of DME despite monthly anti-VEGF injections and/or (4) similar BCVA but worsening of DME; and/or (5) decreased in BCVA and a CRT thickening [ 25 ].…”
Section: Methodsmentioning
confidence: 99%
“…In a previous paper, we assessed the clinical and economic consequences of an extension of initial anti-VEGF treatment from 3 to 6 monthly injections in patients with persistent central-involved DME and visual impairment based on the findings of the post hoc analyses of the DRCR.net Protocol T clinical trial. The results of the study showed that for the total number of patients treated, an average of €7927.02 per additional responder patient would be necessary [ 25 ].…”
Background
To evaluate the cost-effectiveness of early- versus late-switch to the intravitreal-dexamethasone implant (DEX-i) in patients with diabetic macular edema (DME) who did not adequately respond to vascular endothelial growth factor inhibitors (anti-VEGF).
Methods
Retrospective analysis of a multicenter Clinical Data Registry. The registry included DME eyes who received 3 intravitreal anti-VEGF injections (early-switch) or > 3 intravitreal anti-VEGF injections (late-switch) before switching to DEX-i injections. The primary outcome was to estimate the incremental cost needed to obtain a best-corrected visual acuity (BCVA) improvement ≥ 0.1 or a central-retinal thickness CRT ≤ 250 μm.
Results
The analysis included 108 eyes, 32 (29.6%) and 76 (70.4%) in the early- and late-switch groups, respectively. Early-switch strategy was associated with a cost saving of €3,057.8; 95% CI: €2,406.4–3,928.4, p < 0.0001). Regarding incremental-cost-effectiveness ratio, late-switch group was associated with an incremental cost of €25,735.2 and €13,533.2 for achieving a BCVA improvement ≥ 0.1 at month 12 and at any of the time-point measured, respectively. At month 12, 38 (35.2%) eyes achieved a BCVA improvement ≥ 0.1. At month 12, 52 (48.1) eyes had achieved a CRT ≤ 250 micron. As compared to baseline, the mean (95% CI) CRT reduction was − 163.1 (− 212.5 to − 113.7) µm and − 161.6 (− 183.8 to − 139.3) µm in the early-switch and late-switch groups, respectively, p = 0.9463.
Conclusions
In DME eyes, who did not adequately respond to anti-VEGF, switching to DEX-i at early stages (after the first 3-monthly injections) was found to be more cost-effective than extending the treatment to 6-monthly injections of anti-VEGF.
“…In a previous paper published by our group, we evaluated the cost of extending the anti-VEGF treatment from 3 to 6 monthly injections [ 25 ]. This study revealed the incremental costs of extending the anti-VEGF dose in central-involved DME patients who initially did not respond adequately to treatment.…”
Section: Discussionmentioning
confidence: 99%
“…“Not-adequately” respond to anti-VEGF was defined if after 3 anti-VEGF injections (either ranibizumab, bevacizumab, or aflibercept), there was (1) no improvement in best corrected visual acuity (BCVA) and/or (2) a central retinal thickness (CRT) reduction < 20% and/or (3) recurrence of DME despite monthly anti-VEGF injections and/or (4) similar BCVA but worsening of DME; and/or (5) decreased in BCVA and a CRT thickening [ 25 ].…”
Section: Methodsmentioning
confidence: 99%
“…In a previous paper, we assessed the clinical and economic consequences of an extension of initial anti-VEGF treatment from 3 to 6 monthly injections in patients with persistent central-involved DME and visual impairment based on the findings of the post hoc analyses of the DRCR.net Protocol T clinical trial. The results of the study showed that for the total number of patients treated, an average of €7927.02 per additional responder patient would be necessary [ 25 ].…”
Background
To evaluate the cost-effectiveness of early- versus late-switch to the intravitreal-dexamethasone implant (DEX-i) in patients with diabetic macular edema (DME) who did not adequately respond to vascular endothelial growth factor inhibitors (anti-VEGF).
Methods
Retrospective analysis of a multicenter Clinical Data Registry. The registry included DME eyes who received 3 intravitreal anti-VEGF injections (early-switch) or > 3 intravitreal anti-VEGF injections (late-switch) before switching to DEX-i injections. The primary outcome was to estimate the incremental cost needed to obtain a best-corrected visual acuity (BCVA) improvement ≥ 0.1 or a central-retinal thickness CRT ≤ 250 μm.
Results
The analysis included 108 eyes, 32 (29.6%) and 76 (70.4%) in the early- and late-switch groups, respectively. Early-switch strategy was associated with a cost saving of €3,057.8; 95% CI: €2,406.4–3,928.4, p < 0.0001). Regarding incremental-cost-effectiveness ratio, late-switch group was associated with an incremental cost of €25,735.2 and €13,533.2 for achieving a BCVA improvement ≥ 0.1 at month 12 and at any of the time-point measured, respectively. At month 12, 38 (35.2%) eyes achieved a BCVA improvement ≥ 0.1. At month 12, 52 (48.1) eyes had achieved a CRT ≤ 250 micron. As compared to baseline, the mean (95% CI) CRT reduction was − 163.1 (− 212.5 to − 113.7) µm and − 161.6 (− 183.8 to − 139.3) µm in the early-switch and late-switch groups, respectively, p = 0.9463.
Conclusions
In DME eyes, who did not adequately respond to anti-VEGF, switching to DEX-i at early stages (after the first 3-monthly injections) was found to be more cost-effective than extending the treatment to 6-monthly injections of anti-VEGF.
“…Various kinds of anti-VEGF drugs are commonly used in DME treatment, including imported drugs, such as ranibizumab. These drugs bind to and inhibit VEGF receptors to prevent the formation of specific receptors of neovascularization, and therefore, blood glucose and its effects such as retinal capillary permeability can be reduced to improve vision[ 15 ]. Compaq eye injections have a significant effect on neovascularization inhibition to reduce VEGF concentration and vascular wall permeability in the eyes and reduce the infiltration of blood vessels; therefore, retinal edema can be absorbed and the degree of macular edema can be relieved to significantly improve visual performance.…”
BACKGROUND
Diabetes is a serious public health concern in China, with 30% of patients developing retinopathy, and diabetic macular edema (DME) having the biggest impact on vision. High blood glucose level can cause retinal cell hypoxia, thus promoting vascular endothelial growth factor (VEGF) formation and increasing vascular permeability, which induces DME. Moreover, cell hypoxia can accelerate the rate of apoptosis, which leads to the aging of patients. In severe cases, optic cell apoptosis or retinal fibrosis and permanent blindness may occur.
AIM
To investigate and compare the efficacy, mechanism, and differences between two anti-VEGF drugs (Compaq and ranibizumab) in DME patients.
METHODS
Ninety-six patients with DME who attended our hospital from April 2018 to February 2020 were included and randomly divided into two groups (Compaq group and ranibizumab group). The groups received vitreal cavity injections of 0.5 mg Compaq and 0.5 mg ranibizumab, respectively, once a month. The best corrected visual acuity (BCVA), intraocular pressure (IOP), macular retinal thickness (CMT), macular choroidal thickness (SFCT), foveal no perfusion area (FAZ), superficial capillary density, deep capillary density, treatment effect, and adverse reactions were compared before and after treatment and between the two groups.
RESULTS
Before treatment and 1-mo post-treatment, there was no statistically significant difference in the estimated BCVA in both groups (
P
> 0.05). BCVA decreased in the Compaq group 3 mo after treatment, and the difference was statistically significant (
P
< 0.05). Before treatment, and 1 mo and 3 mo post-treatment, there was no statistically significant difference in the estimated IOP in either group (
P
> 0.05). Before treatment and 1-mo post-treatment, there was no statistically significant difference in the estimated CMT, SFCT, or FAZ in either group (
P
> 0.05). CMT and SFCT values decreased in the Compaq group 3 mo post-treatment, and the difference was statistically significant (
P
< 0.05). Before treatment, and 1 mo and 3 mo post-treatment, there were no statistically significant differences in vascular density in the shallow or deep capillary plexi of the fovea, parafovea, or overall macular area between the two groups (
P
> 0.05). Marked efficient, effective, and invalid rates were 70.83% and 52.08%, 27.08% and 39.58%, and 2.08% and 8.33% in the Compaq and ranibizumab groups, respectively. The differences between the two groups were statistically significant (
P
< 0.05).
CONCLUSION
Anti-VEGF drugs can effectively improve CMT and SFCT, without affecting microcirculation, thus providing an effective and safe treatment for patients with DME.
“…Associated SWiT therapy (Fig. 5 ) leads to fewer follow-up visits and decreases the burden costs for long-term treatment, as revealed in a 24-week Protocol T post hoc analysis, where it was shown that extending the anti-VEGF loading dose from 3 to 6 injections requires investing €5882.77 (8 injections), €10,091.03 (14 injections), and €10,198.59 (30 injections) per additional responder patient (3-month nonresponders and 6-month responders) to aflibercept, ranibizumab, and bevacizumab, respectively [ 43 ]. Fig.…”
Background
Diabetic macular edema (DME) is the main cause of visual loss in diabetic patients. Despite the use of anti-VEGF therapy as first-line treatment, there are many patients whose response to treatment is poor or transient at best. Sophisticated laser techniques have emerged aiming at low-intensity retinal damage, avoiding excessive heat that causes tissue necrosis and related collateral effects.
Objective
To evaluate the effect of combined sublethal laser modalities from short-pulse duration (SPD) with endpoint management (EpM) subthreshold laser [named the “sandwich technique” (SWiT)] on central subfield thickness (CST) and best-corrected visual acuity (BCVA) in patients with DME.
Material and methods
In this consecutive retrospective study, 37 patients (37 eyes) with center-involved (CI) DME were treated with SWiT laser therapy from April 2017 to June 2021. The technique consisted of a mean number of 200 (range number 50–400) SPD laser burns OCT-guided thickened area performed on the juxta- and perifoveal area 500 µm away from the foveal center, overlapping with a mean number of 1000 (range number 800–1200) EpM laser burns focused on 6 mm macular diameter area but saving 300 µm toward the foveal center. All patients underwent ophthalmological evaluations, including BCVA and CST measurement by spectral-domain optical coherence tomography (SD-OCT), before and after SWiT laser therapy. The mean follow-up time was 19.2 months (range 2–60 months).
Results
Thirty-five out of 37 cases showed an improvement in CST and BCVA following treatment. At baseline, mean CST (µm) ± standard error (SE) and mean BCVA (logMAR) ± SE was 456.95 ± 37.00 and 0.71 ± 0.29, respectively. After a mean follow-up of 19.2 months, mean CST (µm) ± SE and BCVA (logMAR) ± SE were 272.09 ± 9.10 (p < 0.0001) and 0.54 ± 0.26 (p = 0.003), respectively. A statistically significant reduction in CST and improvement in BCVA was noted after laser therapy application. The anti-VEGF injection frequency was reduced during the mean 19.2 months of the study period.
Conclusions
The novel “sandwich” laser therapy aid reduced CST and improved BCVA in this retrospective case series. Further prospective studies are warranted.
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