RaScaL: A Pilot Study to Assess the Efficacy, Durability, and Safety of a Single Intervention with Ranibizumab plus Peripheral Laser for Diabetic Macular Edema Associated with Peripheral Nonperfusion on Ultrawide-Field Fluorescein Angiography

2014 ◽  
Vol 233 (2) ◽  
pp. 89-95 ◽  
Author(s):  
Ivan J. Suñer ◽  
Marc C. Peden ◽  
Mark E. Hammer ◽  
W. Sanderson Grizzard ◽  
Janet Traynom ◽  
...  
Keyword(s):  
Pilot Study ◽  
Fluorescein Angiography ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Intravitreal Ranibizumab ◽  
Foveal Thickness ◽  
Central Foveal Thickness ◽  
Treatment Naïve ◽  
Prospective Phase ◽  
Single Intervention

Background and Objectives: To determine the efficacy, durability, and safety of a single treatment with intravitreal ranibizumab plus peripheral scatter laser (RaScaL) in patients with diabetic macular edema associated with peripheral retinal nonperfusion on ultrawide-field fluorescein angiography (UWFA). Study Design: A 6-month, randomized, controlled, prospective phase I/II study of 30 treatment-naïve eyes of 22 patients (8 bilateral patients) with visual impairment secondary to diabetic macular edema associated with peripheral nonperfusion on UWFA. Patients were randomized to receive ranibizumab plus UWFA-guided peripheral scatter laser (n = 15) or triamcinolone acetonide plus macular laser (n = 15). Results: At 6 months, the RaScaL group patients had fewer recurrences warranting retreatment (33% vs. 80%, p < 0.003). Mean change in final visual acuity and central foveal thickness were not statistically significant between groups. Conclusion: This pilot study suggests the efficacy, safety and durability of the RaScaL treatment regimen in patients with diabetic macular edema associated with peripheral nonperfusion on UWFA.

scholarly journals Comparison of Intravitreal Dexamethasone Implant and Ranibizumab in Vitrectomized Eyes with Diabetic Macular Edema

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Jia-Kang Wang ◽  
Tzu-Lun Huang ◽  
Pei-Yao Chang ◽  
Wei-Ting Ho ◽  
Yung-Ray Hsu ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Glycosylated Hemoglobin ◽  
Dexamethasone Implant ◽  
Intravitreal Ranibizumab ◽  
Foveal Thickness ◽  
Central Foveal Thickness ◽  
Intravitreal Dexamethasone Implant ◽  
Intravitreal Dexamethasone ◽  
Treatment Number

Purpose. This retrospective study aimed to compare the efficacy of intravitreal ranibizumab (IVR) and intravitreal dexamethasone implant (IDI) for pseudophakic vitrectomized eyes with diabetic macular edema (DME) in a single institution. Methods. Pseudophakic vitrectomized eyes with treatment-naïve center-involved DME were enrolled, with one eye in each patient. They were divided into two groups: one group receiving IDI every 3 to 4 months and another group receiving IVR using 3 monthly plus treat-and-extend injections, all with monthly follow-up for 6 months. Switch of intravitreal drugs or deferred macular laser was not allowed. Primary outcome measures included change in central foveal thickness (CFT) in 1 mm by spectral-domain optical coherence tomography and best-corrected visual acuity (BCVA) at Month 6. Results. Twenty-two eyes were included in the IDI group and 26 eyes in the IVR group. The baseline demographics, glycosylated hemoglobin level, intraocular pressure (IOP), BCVA, and CFT did not significantly differ ( p > 0.05 ). Compared to baseline data, CFT decreased and BCVA improved significantly after either IDI or IVR at Month 6 ( p < 0.05 ). Significantly better mean final BCVA (0.38 logMAR vs. 0.62 logMAR, p = 0.04 ), more mean visual gain (−0.30 logMAR vs. −0.15 logMAR, p = 0.02 ), lower mean final CFT (310.9 μm vs. 384.2 μm, p = 0.04 ), and larger mean CFT decrease (−150.0 μm vs. −60.1 μm, p = 0.03 ) were found in the IDI group compared to those in the IVR group. A smaller mean treatment number (2.6 vs. 5.6, p < 0.001 ) and higher rate of postinjection ocular hypertension requiring topical hypotensive agent therapy (27.3% vs. 0%, p = 0.0002 ) were demonstrated in the IDI group than those in the IVR group. Conclusion. We concluded that IDI and IVR can both effectively treat vitrectomized eyes with DME. Dexamethasone implants had significantly better visual/anatomical improvement, smaller treatment number, and higher rate of elevated IOP after injection than IVR in pseudophakic vitrectomized eyes with DME in a 6-month period.

scholarly journals Clinical impact of the 0.2 µg/day fluocinolone acetonide intravitreal implant: outcomes from the ILUVIEN® clinical evidence study in Portugal

2020 ◽  
Vol 12 ◽  
pp. 251584142091776
Author(s):  
Angela Carneiro ◽  
Angelina Meireles ◽  
João Paulo Castro Sousa ◽  
Carla Teixeira
Keyword(s):  
Visual Acuity ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Clinical Evidence ◽  
Fluocinolone Acetonide ◽  
Foveal Thickness ◽  
Time Points ◽  
Central Foveal Thickness ◽  
Study Population ◽  
Fluocinolone Acetonide Implant

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.

scholarly journals Correlation of Volume of Macular Edema with Retinal Tomography Features in Diabetic Retinopathy Eyes

2021 ◽  
Vol 11 (12) ◽  
pp. 1337
Author(s):  
Santosh Gopi Krishna Gadde ◽  
Arpita Kshirsagar ◽  
Neha Anegondi ◽  
Thirumalesh B. Mochi ◽  
Stephane Heymans ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Macular Edema ◽  
Response To Treatment ◽  
Foveal Thickness ◽  
Naive Group ◽  
Central Foveal Thickness ◽  
Edema Volume ◽  
Raster Scan ◽  
Treatment Naïve

Optical coherence tomography (OCT) enables the detection of macular edema, a significant pathological outcome of diabetic retinopathy (DR). The aim of the study was to correlate edema volume with the severity of diabetic retinopathy and response to treatment with intravitreal injections (compared to baseline). Diabetic retinopathy (DR; n = 181) eyes were imaged with OCT (Heidelberg Engineering, Germany). They were grouped as responders (a decrease in thickness after intravitreal injection of Bevacizumab), non-responders (persistent edema or reduced decrease in thickness), recurrent (recurrence of edema after injection), and treatment naïve (no change in edema at follow-up without any injection). The post-treatment imaging of eyes was included for all groups, except for the treatment naïve group. All eyes underwent a 9 × 6 mm raster scan to measure the edema volume (EV). Central foveal thickness (CFT), central foveal volume (CFV), and total retinal volume (TRV) were obtained from the early treatment diabetic retinopathy study (ETDRS) map. The median EV increased with DR severity, with PDR having the greatest EV (4.01 mm3). This correlated positively with TRV (p < 0.001). Median CFV and CFT were the greatest in severe NPDR. Median EV was the greatest in the recurrent eyes (4.675 mm3) and lowest (1.6 mm3) in the treatment naïve group. Responders and non-responders groups had median values of 3.65 and 3.93 mm3, respectively. This trend was not observed with CFV, CFT, and TRV. A linear regression yielded threshold values of CFV (~0.3 mm3), CFT (~386 µm), and TRV (~9.06 mm3), above which EV may be detected by the current scanner. In this study, EV provided a better distinction between the response groups when compared to retinal tomography parameters. The EV increased with disease severity. Thus, EV can be a more precise parameter to identify subclinical edema and aid in better treatment planning.

scholarly journals Differentiating features of OCT angiography in diabetic macular edema

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Reza Mirshahi ◽  
Hamid Riazi-Esfahani ◽  
Elias Khalili Pour ◽  
Kaveh Fadakar ◽  
Parsa Yarmohamadi ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Optical Coherence Tomography Angiography ◽  
Vascular Density ◽  
Diabetic Patients ◽  
Foveal Thickness ◽  
Central Foveal Thickness ◽  
Capillary Plexus ◽  
Superficial Capillary Plexus

AbstractThe purpose of current study was to evaluate different optical coherence tomography angiography (OCTA) metrics in eyes with diabetic retinopathy with and without diabetic macular edema (DME). In this retrospective study, macular OCTA images of eyes with non-proliferative or proliferative diabetic retinopathy were evaluated. Vascular density, vascular complexity and non-perfusion densities were compared between eyes with and without DME. One-hundred-thirty-eight eyes of 92 diabetic patients including 49 eyes with DME were included. In multivariate analysis, the presence of DME was positively associated with geometric perfusion deficit (GPD) in superficial capillary plexus (SCP), capillary non-perfusion (CNP) of SCP, and GPD in deep capillary plexus (DCP) (all P < 0.05). In eyes with DME, central foveal thickness was associated with VD ratio (SCP/DCP) (P = 0.001) and FAZ area (P = 0.001). In conclusion, in eyes with diabetic retinopathy, the presence of DME was associated with more extensive capillary non-perfusion compared to those with no macular edema.

scholarly journals Comparison of outcomes between intravitreal ranibizumab and intravitreal aflibercept for diabetic macular edema with “Treat-and-Extend” regimen

2020 ◽  
Author(s):  
Masahiko Sugimoto ◽  
Shinichiro Chujo ◽  
Taku Sasaki ◽  
Atsushi Ichio ◽  
Ryohei Miyata ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Retinal Thickness ◽  
Intravitreal Ranibizumab ◽  
Treat And Extend ◽  
Corrected Visual Acuity ◽  
Anti Vegf ◽  
Intravitreal Aflibercept ◽  
Treatment Naïve ◽  
Treat And Extend Regimen

Abstract Background To compare the effectiveness of intravitreal ranibizumab (IVR) and intravitreal aflibercept (IVA) performed with the Treat-and-Extend (TAE) regimen on eyes with diabetic macular edema (DME).Patients and methods This was a retrospective study of 125 eyes of 125 treatment naïve DME patients who received anti-VEGF injections at 3 consecutive monthly intervals as the loading phase. Of these 125 eyes, 26 eyes completed the treatment with the TAE regimen for at least 24 months. Among the 26 eyes, 13 eyes of 13 patients (mean age, 70.9±6.0 years) received intravitreal injections of 0.5 mg ranibizumab and 13 eyes of 13 patients (65.9±8.6 years) received 2 mg aflibercept. The changes in the best-corrected visual acuity (BCVA), central retinal thickness (CRT), diabetic retinopathy severity (DRS), and total injection numbers were compared between the two anti-VEGF agents.Results No significant differences were detected in the baseline demographics. At 24 months, the BCVA was significantly improved in both groups; from 0.31±0.19 to 0.10±0.12 logMAR units for IVR and 0.41±0.19 to 0.16±0.28 logMAR units for IVA ( P=1.29x10 -9 ). The CRT was significantly reduced in both groups; 440.9±69.3 to 307.5±66.4 μm for IVR and 473.9±71.5 to 317.8±71.2 μm for IVA ( P=3.55x10 -9 ). No significant differences were detected in the improvements of the BCVA and the CRT in both groups, and the total injection numbers were significant fewer for the IVA group (11.0±1.2) than the IVR group (12.0±1.0). The DRS was significantly improved in both groups ( P =0.0004 for IVR and P =0.009 for IVA).Conclusion No significant differences were detected in the improvements of the BCVA or CRT and injection numbers between IVR and IVA groups treated with the TAE regimen. These results indicate that the results of the treatment with both agents with the TAE regimen were equally effective.

scholarly journals Topical Triamcinolone Acetonide-Loaded Liposome Formulation Used as an Adjuvant to Intravitreal Ranibizumab Therapy for Neovascular Age-Related Macular Degeneration

Pharmaceutics ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 1491
Author(s):  
Jose Navarro-Partida ◽  
Juan Carlos Altamirano-Vallejo ◽  
Luis Abraham Aceves Franco ◽  
Jesús Gonzalez-Cortes ◽  
Sergio Hernandez-Da Mota ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Triamcinolone Acetonide ◽  
Age Related Macular Degeneration ◽  
Intravitreal Ranibizumab ◽  
Foveal Thickness ◽  
Central Foveal Thickness ◽  
Liposome Formulation ◽  
Age Related ◽  
Treatment Naïve ◽  
Vitreoretinal Diseases

Novel strategies have been developed to reduce or avoid intravitreal injections (IVTs) of the antiangiogenic (ranibizumab (RBZ)) and anti-inflammatory (triamcinolone acetonide (TA)) agents used to treat vitreoretinal diseases. One of the strategies includes liposomes. This study evaluated the safety and efficacy of a topical triamcinolone-loaded liposome formulation (TALF) as an adjuvant to intravitreal RBZ therapy in treatment- naïve patients with neovascular age-related macular degeneration (nAMD). Subjects were randomly assigned to the RBZ-TALF or the RBZ-pro re nata (RBZ-PRN) groups. Patients from the RBZ-TALF group were instructed to apply TALF for 12 months after a single dose of RBZ. Patients from the RBZ-PRN group received three monthly RBZ-IVTs. Retreatment with RBZ was considered in the case of nAMD reactivation. Regarding safety, non-ocular abnormalities were observed during TALF therapy. Concerning efficacy, non-significant differences were identified in terms of visual acuity or central foveal thickness when the RBZ-PRN and RBZ-TALF groups were compared. It is worth noting that the average number of RBZ injections was significantly lower in the RBZ-TALF group (2.5 ± 1.4 vs. 6.1 ± 1.3 IVTs; p = 0.0004). Therefore, TALF used as an adjuvant to RBZ reduces the need for RBZ-IVT retreatment with optimal visual and anatomic results.

scholarly journals Renal Biomarkers for Treatment Effect of Ranibizumab for Diabetic Macular Edema

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Ivan Pochou Lai ◽  
Wei-Lun Huang ◽  
Chung-May Yang ◽  
Chang-Hao Yang ◽  
Tzyy-Chang Ho ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Intravitreal Ranibizumab ◽  
Foveal Thickness ◽  
Corrected Visual Acuity ◽  
Visual Improvement ◽  
Renal Biomarkers ◽  
One Year ◽  
Ranibizumab Treatment

Aims. To investigate the correlations between renal biomarkers and the treatment outcomes of ranibizumab for diabetic macular edema (DME). Methods. This hospital-based study retrospectively enrolled 88 eyes from 67 patients who had received one-year intravitreal ranibizumab treatment for DME. Best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) at baseline and during the follow-up period were recorded. BCVA and OCT characteristics at baseline and their changes after ranibizumab treatment were compared between different proteinuria and estimated glomerular filtration rate (eGFR) groups. Results. Of the 88 eyes studied, those with moderately increased proteinuria had a thicker central subfield foveal thickness (CFT) and a higher proportion of intraretinal cysts than those with no proteinuria (P=0.012 and 0.045, respectively) at baseline. After one year of ranibizumab treatment, the reduction in CFT was greater in patients with severely increased proteinuria than those with normal to mildly increased proteinuria (P=0.030). On the other hand, patients with an eGFR <30 tended to have poorer visual improvements than those with normal eGFR (P=0.044). Conclusions. After ranibizumab treatment for DME, patients with severe proteinuria tended to gain better anatomical improvement, while those with poor eGFR tended to have poorer visual improvement.

scholarly journals Safety and Tolerability of Topical Ophthalmic Triamcinolone Acetonide-Loaded Liposomes Formulation and Evaluation of Its Biologic Activity in Patients with Diabetic Macular Edema

Pharmaceutics ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 322
Author(s):  
Jose Navarro-Partida ◽  
Juan Carlos Altamirano-Vallejo ◽  
Alejandro Gonzalez-De la Rosa ◽  
Juan Armendariz-Borunda ◽  
Carlos Rodrigo Castro-Castaneda ◽  
...  
Keyword(s):  
Biological Activity ◽  
Macular Edema ◽  
Triamcinolone Acetonide ◽  
Diabetic Macular Edema ◽  
Current Data ◽  
Ocular Complications ◽  
Foveal Thickness ◽  
Central Foveal Thickness ◽  
Clinical Assay ◽  
Retinal Disorders

Intravitreal injections (IVTs) of corticosteroids as triamcinolone acetonide (TA) are frequently used for the treatment of many vitreous and retinal disorders. However, IVTs are related to severe ocular complications. Lately, a topical ophthalmic TA-loaded liposomes formulation (TALF) was designed to transport TA into the posterior segment of the eye when instilled on the ocular surface. To evaluate the safety, tolerability, and biological activity of TALF, an animal study and a phase I clinical assay were performed. Moreover, four patients with diabetic macular edema (DME) were treated with TALF in order to explore the biological activity of the formulation. No inflammation, lens opacity, swelling, or increase in intraocular pressure were recorded after the instillation of TALF in any of the animal or clinical studies. Mainly, mild and transient adverse events such as dry eye and burning were reported. TALF significantly improves visual acuity and diminishes central foveal thickness in patients with DME. The current data demonstrate the safety, tolerability, and biological activity of TALF. It seems that TALF can be used topically to treat vitreous and retinal diseases that respond to TA such as DME, avoiding the use of corticosteroid IVTs and their associated hazards.

scholarly journals Pretreatment Neutrophil-to-Lymphocyte Ratio Predicts Prognosis in Patients with Diabetic Macular Edema Treated with Ranibizumab

2019 ◽  
Author(s):  
Yuxiang Hu ◽  
Yi Cheng ◽  
Xiaoxuan Xu ◽  
Bo Yang ◽  
Feng Mei ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Linear Regression Analysis ◽  
Multiple Linear Regression Analysis ◽  
Neutrophil To Lymphocyte Ratio ◽  
Clinicopathological Parameters ◽  
Intravitreal Ranibizumab ◽  
Lymphocyte Ratio ◽  
Treatment Naïve ◽  
The Mean

Abstract Background: To investigate the prognostic value of the neutrophil-to-lymphocyte ratio (NLR) in patients with diabetic macular edema (DME) treated monthly with ranibizumab. Methods: We retrospectively analyzed the medical records of all patients who received intravitreal ranibizumab (IVR) treatment for DME at the First Affiliated Hospital of Nanchang University between December 2015 and December 2017. Clinicopathological parameters, including NLR, were evaluated to identify predictors of better outcomes of IVR monotherapy. Results: Ninety-one treatment-naïve eyes treated with IVR for DME were retrospectively analyzed in this study. Baseline best-corrected visual acuity (BCVA), neutrophils, NLR, monocyte-to-lymphocyte ratio, and platelet-to-lymphocyte ratio were negatively correlated with the changes in BCVA at 24 weeks compared with the baseline, while baseline central retinal thickness and lymphocytes were positively correlated with the changes in BCVA at 24 weeks compared with the baseline. Multiple linear regression analysis revealed that NLR was independently associated with the mean change of BCVA between baseline and week 24. In addition, patients with NLR < 2.27 showed a better improvement in letter score than those with NLR > 2.27. Conclusion: Pretreatment NLR is independently associated with the BCVA in DME patients treated with IVR, and higher pretreatment NLR may contribute to inferior BCVA outcomes.

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