scholarly journals Vitrectomized versus non-vitrectomized eyes in diabetic macular edema response to ranibizumab—retinal layers thickness as prognostic biomarkers

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.

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).


PLoS ONE ◽  
2021 ◽  
Vol 16 (10) ◽  
pp. e0257695
Author(s):  
Francesco Saverio Sorrentino ◽  
Claudio Bonifazzi ◽  
Francesco Parmeggiani

Purpose To suggest the safety and efficacy of preservative-free triamcinolone acetonide intravitreal injectable suspension (Taioftal) for the treatment of diabetic macular edema. Methods A prospective clinical study involved 49 patients (49 eyes), that were treated with Taioftal and followed-up for six months. Complete ophthalmic examination, including spectral domain optical coherence tomography, was performed at baseline, and at month 1, 3, 6 after the intravitreal injection. Accurate collection and analysis of best-corrected visual acuity (BCVA), central foveal thickness (CFT), intraocular pressure (IOP), and adverse events (AEs) were carried out in order to evaluate visual function and macular morphology before and after treatment Results Median BCVA value chosen as comparing statistics was significantly improved at every follow-up time points (gain of 6 letters at month 1, 12 at month 3 –improvement up to 24% at month 3 with stabilization until month 6) compared to baseline, as certified by Kruskal-Wallis rank sum test (P<0.05). Median CFT significantly waned at each follow-up times (decrease of about 65 μm at month 1, 155 at month 3 –reduction up to 28% at month 3 keeping good outcome until month 6) compared to baseline (P<0.05). IOP elevation, with no severe increases, was the most common among spotted AEs (median of 23 mmHg at month 1, 20 at month 3). Conclusion Intravitreal injection of preservative-free triamcinolone (Taioftal) is an effective, safe and inexpensive drug used to improve visual acuity and reduce central foveal thickness in eyes affected by diabetic macular edema during an average time of 6 months. Temporary, never severe, elevation of IOP is totally manageable with topical medications. No serious vision-threatening complications are related to the use of intravitreal triamcinolone injections.


2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Erhan Yumuşak ◽  
Kemal Örnek

Purpose. To compare the efficacy of perioperative ranibizumab injections on diabetic macular edema (DME) in patients undergoing cataract surgery.Methods. This study included 59 eyes of 59 patients. All patients had advanced cataract with DME and underwent an uneventful phacoemulsification surgery. There were 3 subgroups. The first group received intravitreal ranibizumab injection 2 weeks preoperatively, the second group received intraoperatively, and the third group received 2 weeks postoperatively. Follow-up examinations were performed at 1 week as well as at 1 and 3 months.Results. Baseline visual acuity showed a significant increase in all groups at 1 month. In group 1, compared to baseline value, foveal thickness (FT) increased significantly at 1 month and showed a significant decrease up to month 3. In group 2, FT increased at month 1 and this continued up to month 3. In group 3, FT increased at month 1 and was almost stable up to month 3. There were not any significant differences for visual acuity and FT between the groups.Conclusions. Although intrapostoperative ranibizumab injection for DME seems to be more effective than preoperative injections in patients undergoing cataract surgery, the treatment still needs to be continued following surgery.


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.


2007 ◽  
Vol 51 (3) ◽  
pp. 204-209 ◽  
Author(s):  
Yuka Shimonagano ◽  
Reiko Makiuchi ◽  
Miho Miyazaki ◽  
Norihito Doi ◽  
Akinori Uemura ◽  
...  

2020 ◽  
Vol 12 ◽  
pp. 251584142091776
Author(s):  
Angela Carneiro ◽  
Angelina Meireles ◽  
João Paulo Castro Sousa ◽  
Carla Teixeira

Introduction: The ILUVIEN® (fluocinolone acetonide) Clinical Evidence in Portugal (ICE-PT) study is a retrospective, multicenter, observational study evaluating the effectiveness and safety of the FAc implant in patients with diabetic macular edema. Methods: Patients included in this study had received the 0.2 µg/day fluocinolone acetonide implant for the treatment of diabetic macular edema and had measurements of visual acuity and retinal thickness assessed by optical coherence tomography for at least 12 months pre- and post-fluocinolone acetonide implant administration, with ⩾2 follow-up visits. Outcomes measured included visual acuity, central foveal thickness, and intraocular pressure. Results: There was a significant increase in mean visual acuity compared with baseline at 3, 6, 9, and 12 months post-fluocinolone acetonide in both the overall study population and the pseudophakic subgroup ( p < 0.05 at all time points in both groups). A significant reduction in mean central foveal thickness compared with baseline was seen in the overall study population at 3, 6, 9, and 12 months post-fluocinolone acetonide ( p < 0.05 at all time points). At 12-month post-fluocinolone acetonide, a small but significant intraocular pressure increase of 1.0 mmHg was seen in the overall study population. Conclusion: The results of this analysis show that switching from the current standard of care to the fluocinolone acetonide implant leads to beneficial effects in terms of vision and retinal structure in patients with diabetic macular edema and that patients benefited from FAc implant administration, regardless of lens status.


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.


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