scholarly journals Anatomical and functional responses in eyes with diabetic macular edema treated with “1 + PRN” ranibizumab: one-year outcomes in population of mainland China

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Kunbei Lai ◽  
Chuangxin Huang ◽  
Longhui Li ◽  
Yajun Gong ◽  
Fabao Xu ◽  
...  

Abstract Background To evaluate the anatomical and functional responses in eyes with diabetic macular edema (DME) treated with ranibizumab under “1 + pro re nata (PRN)” regimen. Methods This prospective interventional case series included 69 eyes of 69 patients with DME treated with intravitreal injections of 0.5 mg ranibizumab followed by repeated injections as needed. Best-corrected visual acuity (BCVA), central foveal thickness (CFT), subfoveal choroidal thickness (SFCT), and predictive factors for final visual outcomes were assessed. Results Logarithm of minimal angle of resolution (logMAR) BCVA improved from 0.64 ± 0.23 at baseline to 0.56 ± 0.27, 0.53 ± 0.26, 0.47 ± 0.25, 0.44 ± 0.32, 0.47 ± 0.26 and 0.46 ± 0.26 at time-point of months 1, 2, 3, 6, 9, and 12, respectively (P < 0.05 for any follow-up time-point except month 1). CFT decreased from 478.23 ± 172.31 μm at baseline to 349.74 ± 82.21 μm, 313.52 ± 69.62 μm, 292.59 ± 61.07 μm, 284.67 ± 69.85 μm, 268.33 ± 43.03 μm, and 270.39 ± 49.27 μm at above time-points, respectively (P < 0.05). The number of injections was 6.83 times over 12 months’ follow-up under “1 + PRN” regimen. Multivariate analysis showed that the factors including age, BCVA at baseline, disruption of ellipsoid zone, posterior vitreous detachment (PVD), and vitreomacular traction (VMT) were correlated with the final BCVA. Conclusions Intravitreal injections of ranibizumab under “1 + PRN” regimen is a not only effective but also safe way to improve visual acuity of DME patients. And older age, lower baseline BCVA, VMT, and disruption of ellipsoid zone are predictors for final poor BCVA while PVD is a positive predictive factor for good final BCVA. Trial registration The trial was registered retrospectively in ClinicalTrials.gov on 2 June 2019 (NCT03973138).

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Bernardete Pessoa ◽  
João Leite ◽  
João Heitor ◽  
João Coelho ◽  
Sérgio Monteiro ◽  
...  

AbstractTo evaluate the role of the vitreous in the management of diabetic macular edema with ranibizumab intravitreal injections in a pro re nata regimen. Prospective study of 50 consecutive eyes with diabetic macular edema treated with ranibizumab and 12 months of follow-up. Primary endpoint: to assess differences between non-vitrectomized and vitrectomized eyes in the number injections needed to control the edema. Secondary endpoints: comparison of groups regarding best corrected visual acuity, central foveal thickness and thickness of seven retinal layers. 46 eyes from 38 patients, 10 vitrectomized and 36 non-vitrectomized, completed the follow-up. At month 12, the two groups achieved an equivalent anatomical outcome and needed a similar number of ranibizumab intravitreal injections. In vitrectomized eyes final visual acuity was worse when baseline retinal nerve fiber layers in the central foveal subfield were thicker, showing a strong correlation (r = − 0.942, p < 0.001). A similar, albeit moderate correlation was observed in non-vitrectomized eyes (r = − 0.504, p = 0.002). A decrease of retinal nerve fiber layers inner ring thickness was correlated with a better final visual acuity only in vitrectomized eyes (r = 0.734, p = 0.016). The effect of diabetic macular edema seems to be worse in vitrectomized eyes, with a thinner inner retina reservoir.Clinicaltrials.govNCT04387604.


2016 ◽  
Vol 3 (2) ◽  
pp. 30-34
Author(s):  
Prachand Gautam ◽  
Koshal Shrestha ◽  
Gyanendra Lamichhane ◽  
Sushila Patel

INTRODUCTION: Diabetic retionopathy is a microangilpathy. The present study was done to investigate results of Intravitreal Triamcinolone Acetonide injection for the treatment diffuse diabetic macular edema. MATERIAL AND METHODS: The study included 40 eyes of 40 patients with clinically significant diffuse diabetic macular edema. Eyes were diagnosed with diabetic macular edema according to Early Treatment Diabetic Retinopathy Study guidelines. An Intravitreal injection of Triamcinolone Acetonide at the dose of 4 mg/0.2 ml was administered. Best corrected visual acuity was measured as the logarithm of the minimum angle of resolution (logMAR) and snellen vision drum and size of macular edema (hard exudates) was obtained by slit lamp biomicroscopy using +90 D Volk lens at each visit. Intraocular pressure (IOP) and other complications related with steroid and injection related complications were also evaluated. Subsequently patients were followed up on 1st day, 2nd week and 3rd month. RESULTS: All patients were completed second follow up at 3 months. The mean size of macular edema, which obtained at 3 months postoperatively, was significantly different from the baseline measurement from 1.4125 to 0.9474 DD. Mean visual acuity improved significantly from baseline at 3 months of follow up was 0.7421 LogMAR (≈ 6/30 in Snellen chart). Eleven eyes developed intraocular pressure higher than 21 mmHg at 2nd week postoperatively. Other drug and injection related complications were not developed. Increased IOP were controlled with anti glaucoma drugs. CONCLUSIONS: Intravitreal Triamcinolone was a promising therapeutic method for diabetic macular edema. TriamcinoloneAcetonide effectively reduces size of macular edema and improves visual acuity in the short term.Journal of Universal College of Medical Sciences (2015) Vol.03 No.02 Issue 10 Page: 30-34


2018 ◽  
Vol 2018 ◽  
pp. 1-16 ◽  
Author(s):  
Laurent Kodjikian ◽  
David Bellocq ◽  
Thibaud Mathis

Objectives of the Study. Summary of observational studies concerning the pharmacological management of diabetic macular edema (DME). Methods. A literature review was conducted using the PubMed database on 1 February 2018 to identify studies evaluating the efficacy of anti-VEGF and dexamethasone (DEX) implants for DME. Studies with more than 10 patients and follow-up of more than 6 months were selected. Analyses were carried out on the overall population and on subgroups defined according to baseline visual acuity (BVA) and the patients’ naïve or non-naïve status. Results. Thirty-two studies evaluating the efficacy of anti-VEGF and 31 studies evaluating the efficacy of DEX-implants were retained, concerning 6,842 and 1,703 eyes, respectively. A mean gain of +4.7 letters for a mean of 5.8 injections (mean follow-up: 15.6 months) and +9.6 letters for a mean of 1.6 injections (10.3 months) was found in the anti-VEGF and DEX-implant studies, respectively. Final VA appears to be similar for both treatment (62 letters for anti-VEGF, 61.2 letters for DEX-implant), and BVA appears lower for DEX-implant, which may partially explain the greater visual gain. The DEX-implant studies show greater gains in VA compared to the anti-VEGF studies, especially for higher BVA. Indeed, mean gains for the subgroups of patients with BVA<50 letters, 50<BVA<60 letters, and BVA>60 letters are +4.3, +5.8, and +3.1 letters, respectively, in the anti-VEGF studies and +10.5, +9.3, and +8.8 letters, respectively, in the DEX-implant studies. Regarding the patient’s initial status, only naïve status appears to confer the best functional response in DEX-implant studies. Conclusion. Observational studies investigating DEX-implant report clinically similar final VA when compared to anti-VEGF, but superior visual gains in real-life practice. This latter difference could be due to the better BVA, but also to the fact that less injections were administered in the anti-VEGF observational studies than in the interventional studies.


2019 ◽  
Vol 30 (2) ◽  
pp. 363-369 ◽  
Author(s):  
Abdullah Ozkaya ◽  
Gokhan Demir ◽  
Asli Kirmaci

Purpose: To compare the efficacy of ranibizumab and aflibercept in the treatment of diabetic macular edema associated with subfoveal retinal detachment. Methods: This is a retrospective, comparative study. The treatment-naïve diabetic macular edema patients who had diabetic macular edema associated with subfoveal retinal detachment and underwent intravitreal aflibercept or intravitreal ranibizumab treatment were included. The patients were treated on a pro re nata treatment regimen after a loading dose of 3-monthly injections and the follow-up time was 12 months. The primary outcome measure of this study was the presence of subfoveal retinal detachment after treatment at different time points. The secondary outcome measures were the change in best corrected visual acuity and central retinal thickness. Results: A total of 46 eyes of 46 patients were included. The aflibercept group consisted of 20 and the ranibizumab group consisted of 26 eyes. During the follow-up period of 12 months, subfoveal retinal detachment was completely resolved in 75% versus 57.7% of the eyes at month 3 (p = 0.2), 90% versus 76.9% at month 6 (p = 0.2), 90% versus 65.4% at month 9 (p = 0.05), and 100% versus 80.8% at month 12 (p = 0.03) in the intravitreal aflibercept versus intravitreal ranibizumab groups. The change in best corrected visual acuity was not statistically different between the groups at months 3, 6, 9, and 12, respectively (p > 0.05 for all). Conclusion: Both intravitreal aflibercept and intravitreal ranibizumab were effective in regards to anatomical and functional outcomes of diabetic macular edema patients associated with subfoveal retinal detachment. Interestingly, intravitreal aflibercept seemed more effective than intravitreal ranibizumab in the resolution of subfoveal retinal detachment at month 12.


2017 ◽  
Vol 28 (1) ◽  
pp. 74-79 ◽  
Author(s):  
Giuseppe Lo Giudice ◽  
Antonio Avarello ◽  
Gianluca Campana ◽  
Alessandro Galan

Purpose: To evaluate the early effects of dexamethasone (DEX) intravitreal implants in patients with diabetic macular edema (DME). Methods: This was a prospective, single-arm, interventional clinical series. Eighteen patients (18 eyes) with chronic/recalcitrant or naive DME were included. Patients underwent single DEX intravitreal implant. Clinical assessments, including ophthalmologic examination, central retinal thickness (CRT) measurement by spectral-domain optical coherence tomography (SD-OCT) scan, best-corrected visual acuity (BCVA), and intraocular pressure (IOP) were carried out at baseline, 1-3 hours, and then 3, 7, and 30 days after treatment. The main outcome was change in CRT on SD-OCT, while secondary outcome measures included visual acuity (VA) and changes in IOP following implant. Results: Mean CRT significantly decreased from 565 ± 171 µm at baseline to 310 ± 89 µm at end of follow-up (p<0.001), with reduction becoming evident 1-3 hours after injection. Mean BCVA also significantly improved 7 days and 30 days after treatment up to 0.14 logMAR (p<0.05). All patients had a controlled IOP after the injection with only 1/18 eyes having a transient increase in IOP during follow-up. Conclusions: This is the first study showing very early effects of DEX implants on CRT reduction and VA improvement in DME.


2016 ◽  
Vol 27 (2) ◽  
pp. 210-214 ◽  
Author(s):  
Gabriel Katz ◽  
Elad Moisseiev ◽  
Dafna Goldenberg ◽  
Joseph Moisseiev ◽  
Yosef Lomnicky ◽  
...  

Purpose To evaluate the efficacy of switching from bevacizumab to ranibizumab in patients with diabetic macular edema (DME). Methods This was a retrospective study of patients with DME initially treated with bevacizumab and switched to ranibizumab. Visual acuity (VA) and central retinal thickness (CRT) were retrieved at fixed timepoints prior to and after the switch. Results Forty eyes of 32 patients were included in the study. The difference in VA between any of these fixed timepoints was not statistically significant. A significant gain in VA was found in eyes that lost more than 0.1 logMAR during treatment with the last 3 bevacizumab injections. The mean CRT was significantly lower after the first 3 ranibizumab injections and at the final follow-up (p<0.001), a 67 ± 14 μm and 78 ± 18 μm reduction in thickness, respectively. Conclusions Switching to ranibizumab resulted in a significant decrease in the CRT of eyes with DME, and should be considered when there is a lack of response or deterioration while on bevacizumab injections. A significant gain in VA was observed in a subgroup of eyes that lost more than one line while receiving the last 3 bevacizumab injections prior to the switch.


2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Lucy J. Kessler ◽  
Gerd U. Auffarth ◽  
Dmitrii Bagautdinov ◽  
Ramin Khoramnia

Purpose. Ellipsoid zone (EZ) integrity is identified as a potential biomarker for therapy surveillance and outcome prediction of visual acuity (VA). However, only a few studies report long-term results of over 1 year of clinical and anatomical changes in patients with diabetic macular edema (DME). This study is aimed at describing the long-term VA and anatomical outcomes in spectral domain optical coherence tomography (OCT) (relative ellipsoid zone reflectivity ratio, central macular thickness, and volume) in patients with DME treated with antivascular endothelial growth factor (anti-VEGF) therapy. Furthermore, we studied the correlation between EZ integrity and changes in visual acuity. Methods. 71 eyes of 71 patients were included in this retrospective study. Clinical characteristics were reviewed yearly. OCT data were assessed at baseline and after 1, 3, and 5 years. EZ parameters were quantified automatically. OCT parameters and visual outcome were correlated and analyzed in multivariable regression models. Results. EZ reflectivity ratio correlated with functional outcome in DME patients from baseline to fifth year at all time points (for all p < 0.05 ). EZ reflectivity improved the most in the first year of treatment (0.68 to 0.75; p < 0.05 ) and declined gradually until year 5 of therapy (0.71; compared to baseline p > 0.05 ). Similarly, best VA was achieved after 1 year (0.40 logarithm of the minimum angle of resolution (logMAR) to 0.28 logMAR; p < 0.001 ) and declined gradually until year 5. Final VA in year 5 was comparable to baseline (0.45 logMAR, compared to baseline p > 0.05 ). Together with baseline VA, baseline EZ parameters did predict VA outcome after 1 year ( p < 0.05 ). Concordantly, VA and EZ parameters from year 1 were associated with VA outcome in year 2. Conclusion. This study described the long-term course of EZ changes during anti-VEGF treatment in DME patients. In addition, our results underlined the potential of EZ parameters as novel OCT biomarkers for prediction of VA outcomes during therapy.


2017 ◽  
Vol 2017 ◽  
pp. 1-4 ◽  
Author(s):  
Filipe Mira ◽  
Manuel Paulo ◽  
Filipe Henriques ◽  
João Figueira

Purpose. The aim was to evaluate the efficacy of aflibercept in patients with diabetic macular edema (DME) unresponsive to prior anti-VEGF therapy. Methods. Retrospective review of DME unresponsive to previous anti-VEGF switched to aflibercept with 3 months of follow-up. Changes in best correct visual acuity (BCVA), central retinal thickness (CRT), and frequency of injections were analyzed. The percentage of subjects who had ≥20/40 (logMAR equivalent 0.3) and ≤20/200 (logMAR equivalent 1) was evaluated. Results. A total of 32 eyes from 26 patients were included. Mean age was 65 ± 10 years old. The mean number of previous anti-VEGF injections was 5.34 ± 2.38, and the mean number of aflibercept injections at the end of the study was 2.00 ± 0.00. The CRT at baseline was 501.47 ± 150.51 μm and 367.97 ± 124.61 μm at 3 months of follow-up (P<0.001). The logMAR BCVA at baseline was 0.71 ± 0.36 and 0.65 ± 0.33 at the end of the follow-up (P=0.037). At baseline, 12.5% of patients had ≥20/40 compared with 25% at the end of follow-up. At baseline, 28.13% of patients had 20/200 or inferior vision compared with 15.63% at the end of the follow-up. Conclusions. DME patients unresponsive to previous multiple ranibizumab injections demonstrate a significant anatomical and functional improvement with the switch to aflibercept.


2021 ◽  
pp. 112067212110248
Author(s):  
Anna V Bux ◽  
Francesca Fortunato ◽  
Antonio Barone ◽  
Vincenzo Russo ◽  
Nicola Delle Noci ◽  
...  

Purpose: To assess the efficacy and safety of dexamethasone 0.7 mg implants (DEX-I) in patients with diabetic macular edema (DME) either naïve to therapy or refractory to anti-VEGF treatment, in a single-center, real-world setting. Methods: Patients diagnosed with DME and treated with DEX-I were retrospectively enrolled in the study and split in two groups: naïve (Group 1, n = 64) and refractory (Group 2, n = 64) to treatment. Patients were evaluated at baseline, at 1 month, and every 3 months after each DEX-I implant. Main outcome measures were change in best-corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline to follow-up visits. Results: Significant improvements in BCVA were observed in treatment-naïve patients at 6 months following the first and second DEX-I injection ( p = 0.0023 and p = 0.0063, respectively), with significant reductions in mean CMT at 6 months after all DEX implants. In treatment-refractory patients, mean CMT was significantly reduced from baseline to 6 months ( p < 0.05) after all DEX-I injections, although no changes were observed in BCVA. Conclusions: DEX-I improved visual acuity and macular edema mostly in treatment-naïve patients, suggesting DEX-I may be a viable first-line treatment option in DME.


2020 ◽  
Vol 161 (49) ◽  
pp. 2078-2085
Author(s):  
Mónika Ecsedy ◽  
Illés Kovács ◽  
Róbert Gergely ◽  
Katalin Gombos ◽  
Judit Meisel ◽  
...  

Összefoglaló. Bevezetés és célkitűzés: A Navilas® 577s mikropulzuslézerrel végzett kezelés biztonságosságának és hatásosságának vizsgálata diabeteses maculaoedemában. Módszer: Retrospektív vizsgálatunkba diabeteses maculaoedema miatt gondozott és legalább 6 hónapos utánkövetéssel rendelkező, korábban Navilas® 577s mikropulzuslézer-kezelésen átesett 28 beteg 46 szemét válogattuk be. Minden szemen optikaikoherencia-tomográfia (OCT) vastagsági térkép navigált, nonkontakt, küszöb alatti mikropulzuslézer-kezelés történt egy alkalommal. A kezelést megelőzően és az azt követő 6. hónapban rögzítettük a látóélesség, a centrális retinavastagság értékeit és az éreredetű endothelialis növekedési faktort (VEGF) gátló injekciók számát. A követési idő végén megvizsgáltuk a szemfenéki képnek a digitális fundusfotográfia és az átmetszeti OCT-képek segítségével észlelhető változásait. Eredmények: A vizsgált szemek közül 30 esetben a lézerkezelést korábbi centrális maculaoedema miatt VEGF-gátló injekciós kezelés előzte meg, míg 16 szem esetében primer lézerkezelés történt. A Navilas® 577s mikropulzuslézer-kezelést követően 6 hónappal sem a látóélesség, sem a centrális maculavastagság nem változott szignifikánsan egyik csoportban sem (p>0,05). Ugyanakkor a korábban injekciós kezelésben részesült szemek esetében a lézerkezelést megelőző 6 hónapban adott injekciók száma az átlagos 2,63 ± 1,18 értékről átlagosan 0,5 ± 0,73 értékre csökkent (p<0,001). A fundusfotókon és az átmetszeti OCT-scaneken a lézerkezelést követően egyetlen szem esetében sem találtunk látható pigmentelváltozásokat vagy hegesedést. Következetetés: Megfigyeléseink szerint a Navilas® 577s mikropulzuslézer-kezelés biztonságos a diabeteses maculaoedemás betegek kezelésében, továbbá a VEGF-gátlóval kezelt szemeken szerepet játszhat az injekciók számának csökkentésében. Orv Hetil. 2020; 161(49): 2078–2085. Summary. Introduction and objective: To assess the safety and efficacy of Navilas® 577s micropulse subthreshold laser in the treatment of non-center involved diabetic macular edema. Method: In this retrospective study, we included 46 eyes of 28 patients with diabetic macular edema, who were treated at least 6 months ago with Navilas® 577s micropulse laser. Laser treatment was navigated by optical coherence tomography (OCT) macular thickness map in subthreshold micropulse mode at one occasion. Data from visual acuity testing, retinal thickness, and the number of anti-vascular endothelial growth factor (VEGF) injections needed 6 months before and after treatment were registered. At the end of the follow-up, digital fundus photography and OCT radial scans were performed to evaluate any possible anatomical changes. Results: 30 eyes had previous anti-VEGF treatment for central macular edema, and in 16 eyes we performed the laser as primary treatment. At the end of the follow-up, no significant visual acuity or central retinal thickness change were observed (p>0.05). On the other hand, in the anti-VEGF pretreated group the number of injections decreased significantly from 2.63 ± 1.18 to 0.5 ± 0.73 (p<0.001). We did not find any pigmentary changes or visible signs of scaring on final fundus photography pictures or OCT radial scans. Conclusion: Navilas® 577s subthreshold microsecond laser proved to be a safe option in the treatment of diabetic macular edema. It can be very useful in anti-VEGF treated eyes by decreasing the number of injections needed. Orv Hetil. 2020; 161(49): 2078–2085.


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