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Comparison of fluorescein angiographic findings in type 1 and type 2 retinopathy of prematurity with intravitreal bevacizumab monotherapy and spontaneous regression
摘要： Purpose To investigate the extent of vascularization of the peripheral retina and vascular development patterns in patients with type 1 retinopathy of prematurity (ROP) treated with intravitreal injection of bevacizumab (IVB) and compare fluorescein angiography (FA) findings of them to those seen in patients with type 2 ROP who have recovered spontaneously. Methods Between May 2014 and September 2016, patients with type 1 ROP who had a single 0.025 ml (0.625 mg) IVB were evaluated as study group. On the other hand, type 2 ROP patients with stage 2 or stage 3 ROP in zone II without plus disease on indirect ophthalmoscopy were not treated and included as a control group. The progression of ROP and vascularization of retina were evaluated by FA under sedation analgesia in all patients. Results Sixty-two eyes of 31 premature infants were included in the study: 36 eyes/18 patients were treated for type 1 ROP and 26 eyes/13 patients were followed conservatively with the diagnoses of type 2 ROP. In the last FA examination among the study group, vascular terminal was in zone II in 8 eyes/4 patients (22.22%) and in zone III in 28 eyes/14 patients (77.78%). Vascular terminal was in zone III in all eyes of the control group (100%). We noted circumferential vessels in 12 eyes/8 patients (33.3%) and 7 eyes/5 patients (26.92%) in the study and control groups, respectively. Abnormal branching was noticed in 13 eyes/7 patients (46.42%) in the control group, whereas it was not detected in the study group. Arteriovenous shunts were noted in 1 eye of a patient in the study group and in 5 eyes/4 patients in the control group. In 6 eyes/3 patients among the study group, we performed laser photocoagulation to the avascular retina because of profound vascular leakage. Conclusion Peripheral vascular abnormalities probably occur as a result of ROP itself because similar FA findings were detected both in type 1 and type 2 ROP patients with or without treatment, although significantly less in IVB-treated group. Retinal vascularization usually reaches the farthermost limits with time even though it slows down in eyes treated with IVB, indicating the importance of a longer follow-up.
关键词： Fluorescein angiography,Bevacizumab,Peripheral vascular abnormalities,Retinopathy of prematurity
更新于2025-09-23 15:23:52
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Pharmacokinetic Simulations of Intravitreal Biologicals: Aspects of Drug Delivery to the Posterior and Anterior Segments
摘要： Biologicals are important ocular drugs that are be delivered using monthly and bimonthly intravitreal injections to treat retinal diseases, such as age-related macular degeneration. Long acting delivery systems are needed for prolongation of their dosing interval. Intravitreal biologicals are eliminated from the eye via the aqueous humor outflow. Thus, the anterior and posterior segments are exposed to the drug. We utilized a kinetic simulation model to estimate protein drug concentrations in the vitreous and aqueous humor after bolus injection and controlled release administration to the vitreous. The simulations predicted accurately the experimental levels of 5 biologicals in the vitreous and aqueous humor. The good match between the simulations and experimental data demonstrated almost complete anterior segment bioavailability, and major dose sparing with ocular controlled release systems. Overall, the model is a useful tool in the design of intraocular delivery of biologicals.
关键词： aflibercept,ocular drug delivery,ranibizumab,intravitreal injection,controlled release,bevacizumab
更新于2025-09-23 15:22:29
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Bevacizumab versus bevacizumab and macular grid photocoagulation for macular edema in eyes with non-ischemic branch retinal vein occlusion: results from a prospective randomized study
摘要： Background The objective of the study was the investigation of the effects of intravitreal bevacizumab (BEV) with or without additional macular grid laser photocoagulation (GRID) for macular edema (ME) secondary to branch retinal vein occlusion (BRVO). Methods Prospective, randomized, monocentric study. Thirty-two patients were included. Initially, all eyes in both groups received three monthly injections of BEV, followed by additional injections if re-treatment criteria were met. In the BEV + GRID group, photocoagulation was performed 2 weeks after the first BEV injection and laser re-treatment was allowed. The follow-up was 38 weeks. Main outcome measures were best-corrected visual acuity (BCVA) and central retinal thickness (CRT). Changes of foveal avascular zone (FAZ) and of retinal ischemia, as well as the number of injections were also evaluated. Results Sixteen eyes were randomized into each group. At baseline, BCVA was similar in both groups (BEV + GRID: 20/71; BEV: 20/60; P = 0.51). At 38 weeks, BCVA significantly improved in the two groups (BEV + GRID gain of 9 ± 11.2 letters and 16.25 ± 10.08 letters in the BEV) with no difference between them (P < 0.06). With regard to anatomical findings, initial CRT in BEV + GRID was 496.2 μm ± 138.4 μm and 538.9 μm ± 156.9 μm in BEV (P < 0.1697). At 38 weeks, CRT decreased in both groups significantly, 98.2 μm in the BEV + GRID (P = 0.02) and 141.7 μm in the BEV group (P = 0.01), with no significant difference between groups (P < 0.17). The area of FAZ a significantly increased in both groups (41% (P = 0.04) in BEV + GRID; 35% (P = 0.03) in BEV) during the study and the grade of peripheral ischemia remained unchanged. The mean number of injections was 3.8 (range 3–6) with no significant difference between groups. Conclusions Our data demonstrate a beneficial effect of bevacizumab in ME in eyes with BRVO. A loading phase of three injections led to a significant improvement in vision in both groups, which persisted at week 38. Additional grid laser photocoagulation exhibited no beneficial functional or anatomical effect during the study, nor did it reduce the number of injections. The FAZ area increased significantly in both groups, but overall retinal ischemia did not. Further studies investigating more numerous eyes and longer follow-up are needed to confirm these data.
关键词： Anti-VEGF,Grid laser photocoagulation,Macular edema,Branch retinal vein occlusion,Bevacizumab
更新于2025-09-23 15:22:29
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Critical evaluation of the off-label indication and of the risks associated to the use of multi-dose vials on the treatment of age-related macular degeneration
摘要： Age-related macular degeneration (AMD) is an ocular inflammatory diseases treated mainly by means of a bevacizumab (Avastin?) or ranibizumab (Lucentis?) intravitreal injection. Among these drugs, only ranibizumab has a specific therapeutic indication for AMD. Considering that, the off-label use on ophthalmic therapy seems to become a rule when it should be an exception. Furthermore, bevacizumab presentation consists of multi-dose vials although it does not contain preservatives in its formula. The current literature review aimed at assessing the risks for the patient related to the use of off-label indication and multi-dose vials on AMD treatment. Considering this, the proposal related to the Brazilian Public Consultation no.10, dated September 12, 2012, which proposes the Clinical Protocol and Therapeutic Guidelines for AMD treatment, was evaluated. This systematic review allowed to conclude that the bevacizumab off-label indication results in increased risks for the patient when compared to the product with specific therapeutic indication for AMD treatment (ranibizumab), especially referring to the significant raise in the adverse events. The risks for the patient related to the multi-dose vial use, referring to the microbiological stability and dose precision, were also made clear.
关键词： Multi-dose vials/patients risks,Ranibizumab/intravitreal injection,Age-related macular degeneration/treatment,Off-label indication/patients risks,Ophthalmic therapy/off-label use,Bevacizumab/intravitreal injection
更新于2025-09-23 15:22:29
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Effect of Anti-vascular Endothelial Growth Factor Antibody on the Survival of Cultured Retinal Ganglion Cells
摘要： Purpose: To investigate the effects of anti-vascular endothelial growth factor (VEGF) antibody on the survival of retinal ganglion cell (RGC)-5 cells differentiated with staurosporine under oxidative stress. Methods: We used real-time polymerase chain reaction and Western blot to confirm the expression of VEGF, VEGF receptor (VEGFR)-1 and VEGFR-2 in RGC-5 cells differentiated with staurosporine for 6 hours. The differentiated RGC-5 cells were treated with 800 μM hydrogen peroxide (H2O2) for 24 hours to induce oxidative stress. Then, the survival rate of RGC-5 was confirmed by lactate dehydrogenase assay at each concentration (0, 0.01, 0.1, and 1 mg) using bevacizumab as the anti-VEGF antibody. The expression of VEGF, VEGFR-1, and VEGFR-2 was confirmed using real-time polymerase chain reaction. Results: VEGF, VEGFR-1, and VEGFR-2 were all expressed in differentiated RGC-5 cells. When RGC-5 cells were simultaneously treated with bevacizumab and 800 μM H2O2, survival of RGC-5 decreased with bevacizumab concentration. VEGF expression in RGC-5 cells increased with increasing concentration of bevacizumab. Similar patterns were observed for VEGFR-1 and VEGFR-2, but the degree of increase was smaller than that for VEGF. Conclusions: When bevacizumab was administered to differentiated RGC-5 cells, the cell damage caused by oxidative stress increased. Therefore, given these in vitro study results, caution should be exercised with bevacizumab treatment.
关键词： Oxidative stress,RGC-5,Retinal ganglion cell,Anti-vascular endothelial growth factor,Bevacizumab
更新于2025-09-23 15:22:29
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Statement of the BVA, the DOG, and the RG on treatment of choroidal neovascularization in diseases other than neovascular age-related macular degeneration; Stellungnahme des BVA, der DOG und der RG zur Therapie chorioidaler Neovaskularisationen bei anderen Erkrankungen als der neovaskul?ren altersabh?ngigen Makuladegeneration (Englische Version);
摘要： Choroidal neovascularizations (CNV) occur not only in age-related macular degeneration (AMD), but also in numerous other macular and retinal disorders of varying etiology and, if left untreated, can cause irreversible visual loss. The diagnosis of CNV as well as the indication for treatment should be made in the same way as in neovascular AMD: On initial diagnosis: best-corrected visual acuity, fundus examination, optical coherence tomography (OCT), and fluorescein angiography. At follow-up: best-correct visual acuity, fundus examination, OCT, and, depending on findings, fluorescein angiography. Active CNV should be treated with intravitreal operative medication (IVOM) using vascular endothelial growth factor (VEGF) inhibitors if patients have visual acuity of at least 0.05 or if there is sufficient reason to assume that visual acuity could increase to over 0.05 under treatment. Underlying disorders can include, e.g., high myopia, angioid streaks, central serous chorioretinopathy, active and inactive uveitis of varying etiology, including retinochoroiditis, chorioretinitis, and choroiditis, eye injuries, retinal dystrophies, e.g., best disease and pattern dystrophies, idiopathic CNV, subretinal masses (osteomas, hamartomas, nevi). If CNV is not present as a complication in the above-mentioned disorders, IVOM with VEGF inhibitors should not be performed. Ranibizumab and aflibercept are approved in Germany for the treatment of CNV secondary to pathologic myopia. Ranibizumab has been approved in Germany since 12/2016 for the treatment of CNV in disorders other than neovascular AMD and pathologic myopia irrespective of the underlying disease. The other VEGF inhibitors, aflibercept and bevacizumab, can be used off-label. Due to its overall significantly poorer treatment results, photodynamic therapy (PDT) should only be used in exceptional cases and extrafoveal localization. After one initial intravitreal administration of VEGF inhibitors, further CNV activity should be monitored monthly for the first 6 months (see point 2). In the case of persisting or recurrent activity, repeated IVOM should be performed. Depending on disease course, the follow-up interval might be extended 6 months after the last IVOM. In individual justified cases (e.g., patients requiring frequent re-injections), a different treatment regimen (e.g., treat and extend) can be considered in the further course. If visual acuity drops below 0.05 on anti-VEGF treatment, or no further positive treatment outcome is expected (e.g., in the presence of atrophy and/or fibrosis), treatment should be discontinued, unless there is a clear possibility that visual acuity could increase again to over 0.05 under treatment. If no improvement is seen under therapy with a certain VEGF inhibitor, or if deterioration occurs, one can consider switching to an alternative VEGF inhibitor.
关键词： Choroidal neovascularization,Myopia,Retinal dystrophies,Ranibizumab,VEGF inhibitors,Uveitis,Idiopathic CNV,Central serous chorioretinopathy,Angioid streaks,Photodynamic therapy,Subretinal tumors,Aflibercept,Bevacizumab,Eye injuries
更新于2025-09-19 17:15:36
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RATES AND RISK FACTORS FOR RECURRENCE OF RETINOPATHY OF PREMATURITY AFTER LASER OR INTRAVITREAL ANTI–VASCULAR ENDOTHELIAL GROWTH FACTOR MONOTHERAPY
摘要： To determine the rates and risk factors of recurrent retinopathy of prematurity (ROP) treated by laser photocoagulation, intravitreal bevacizumab (IVB) monotherapy, or intravitreal ranibizumab (IVR) monotherapy. In this retrospective cohort study, consecutive infants with Type 1 ROP who received laser, IVB, or IVR treatments were followed for at least 75 weeks of postmenstrual age. Data analysis was performed between March 2010 and February 2017 in Chang Gung Memorial Hospital, Linkou, Taiwan. A total of 176 infants (340 eyes) were included in this study. The mean follow-up was 197.3 ± 110 weeks. All of the baseline demographic and ROP characteristics among the laser, IVB, and IVR groups were similar. The overall recurrence rate after treatment was 44 of 340 eyes (12.9%). The IVB group had a recurrence rate of 10.0%, followed by the laser group (18.0%) and the IVR group (20.8%); however, these rates were not signi?cantly different (P = 0.0528). Compared with the laser group, the IVB and IVR groups exhibited recurrence at later ages (43.4 ± 3.5 weeks for the IVB group, 42.3 ± 2.0 weeks for the IVR group, and 39.5 ± 2.8 weeks for the laser group; P = 0.0058). The mean interval of recurrence from initial treatment in the laser group was 3.6 ± 1.4 weeks compared with 8.8 ± 3.9 weeks and 8.3 ± 1.6 weeks in the IVB and IVR groups, respectively (P = 0.0001). Overall, the independent risk factors of recurrence included an early postmenstrual age at initial treatment (P = 0.0160), Zone I (P = 0.0007), low Apgar score (P = 0.0297), and multiple births (P = 0.0285). There was no signi?cant difference in progression to retinal detachment among the three groups (laser: 3/61, 4.9%; IVB: 2/231, 0.9%;and IVR: 1/48, 2.1%; P = 0.2701). Laser, IVR, and IVB are effective for Type 1 ROP. Retinopathy of prematurity recurrence requiring re-treatment was encountered as late as 50 weeks of postmenstrual age after IVB or IVR but earlier after laser. Longer follow-up for infants treated with anti–vascular endothelial growth factor is needed, especially in patients with signi?cant risk factors such as an early postmenstrual age at initial treatment, Zone I ROP, low Apgar score, and multiple births.
关键词： ranibizumab,risk factors,bevacizumab,rates,laser,anti-VEGF,recurrent retinopathy of prematurity
更新于2025-09-12 10:27:22
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SEVERE RECURRENT FIBROVASCULAR PROLIFERATION AFTER COMBINED INTRAVITREAL BEVACIZUMAB INJECTION AND LASER PHOTOCOAGULATION FOR AGGRESSIVE POSTERIOR RETINOPATHY OF PREMATURITY
摘要： To describe the clinical features of severe recurrent fibrovascular proliferation after combined intravitreal bevacizumab injections and laser photocoagulation for aggressive posterior retinopathy of prematurity. This retrospective, nonrandomized case series reviewed the medical and ophthalmic records in the referral hospital and our hospital. Four patients (seven eyes) with aggressive posterior retinopathy of prematurity. The patients were referred for vitrectomy with/without lensectomy for recurrent fibrovascular proliferation with a tractional retinal detachment after combined intravitreal bevacizumab injections and laser photocoagulation. Three patients were born at 22 weeks or 23 weeks’ gestational age and one patient at 29 weeks’ gestational age. Preoperatively, fluorescein angiography images showed all eyes had tractional retinal detachment from regrowth of fibrovascular proliferation 3 months to 5 months after the intravitreal bevacizumab injection and abnormal retinal vasculature; four eyes had a broad ischemic retina. Postoperatively, four eyes had retinal attachment and three eyes a total retinal detachment. Neovascular glaucoma developed in five of the seven eyes during the clinical course. Severe fibrovascular proliferation may recur due to widespread retinal ischemia with capillary dropout and abnormal vasculature after failed combined intravitreal bevacizumab and laser photocoagulation therapy as the initial treatment for aggressive posterior retinopathy of prematurity. Careful follow-up is important especially after anti–vascular endothelial growth factor treatment, with recognition that severe reactivation is possible.
关键词： intravitreal bevacizumab injection,vitrectomy,retinopathy of prematurity,fluorescein angiography,stage 5 ROP,vascular endothelial growth factor,stage 4 ROP,fibrovascular proliferation,laser photocoagulation,ROP surgery
更新于2025-09-12 10:27:22
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Laser and Anti–Vascular Endothelial Growth Factor Agent Treatments for Retinal Arterial Macroaneurysm
摘要： Purpose: to describe the efficacy of laser and intravitreal injection of anti?vascular endothelial growth factor (anti-VEGF) agents for patients with symptomatic retinal arterial macroaneurysm (RAM). Design: From 2009 to 2016, we collected patients with exudative or hemorrhagic RAM all treated by focal laser photocoagulation. Methods: Nd:YAG laser was performed in patients with subinternal limiting membrane (sub-ILM) hemorrhage. Intravitreal anti-VEGF agents were given in eyes with macular exudation as adjuncts. Changes of visual acuity and central foveal thickness before and after treatment were recorded and compared with Wilcoxon signed-rank test. Results: Thirty-five eyes that underwent a single session of laser photocoagulation for RAM resulted in macroaneurysm regression. The hemorrhagic group included 24 eyes having ruptured macroaneurysms without macular exudation. Five eyes with simultaneous sub-ILM hemorrhage receiving Nd:YAG laser membranotomy had resolution of preretinal hemorrhage. Exudative RAM having cystoid macular edema or submacular fluid with or without ruptured macroaneurysms was treated by focal laser photocoagulation alone in 3, or combined with single intravitreal anti-VEGF agent in 8 eyes. All patients had significantly improved vision when comparing visual acuity at baseline and final follow-up (P = 0.00016). Significant reduction of macular thickness was also observed after laser monotherapy or combined treatment in exudative RAM (P = 0.018). Conclusions: Focal laser photocoagulation was helpful for the management of ruptured or leaky RAM. Combined focal laser and intravitreal anti-VEGF agents could better reduce macular exudation caused by RAM. Additionally, Nd:YAG laser was a safe and effective method to remove the sub-ILM hemorrhage caused by RAM.
关键词： retinal arterial macroaneurysm,argon laser,bevacizumab,aflibercept
更新于2025-09-11 14:15:04
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Aflibercept Treatment for Neovascular Age-related Macular Degeneration and Polypoidal Choroidal Vasculopathy Refractory to Anti-vascular Endothelial Growth Factor
摘要： Purpose: To report the results of switching treatment to vascular endothelial growth factor (VEGF) Trap-Eye (aflibercept) in neovascular age-related macular degeneration (AMD) and polypoidal choroidal vasculopathy (PCV) refractory to anti-VEGF (ranibizumab and bevacizumab). Methods: This is a retrospective study involving 32 eyes from 29 patients; 18 were cases of neovascular AMD and 14 were cases of PCV. The best-corrected visual acuity (BCVA) and central macular thickness (CMT) of spectral-domain optical coherence tomography were evaluated. Results: BCVA and CMT improved from 0.58 to 0.55 (p = 0.005) and from 404 to 321 μm (p < 0.001), respectively, after switching to aflibercept. The 14 eyes that received 6 or more aflibercept injections remained stable at 0.81 to 0.81 and 321 to 327 μm (p = 1.0, 0.29), respectively, after 3 aflibercept injections. The 10 eyes that received 3 or more bevacizumab injections after 3 or more aflibercept injections worsened, from 0.44 to 0.47 and from 332 to 346 μm (p = 0.06, 0.05), respectively. The results showed similar improvement of BCVA and CMT in neovascular AMD and PCV. Conclusions: Aflibercept seems to be effective for improvement and maintenance of BCVA and CMT for neovascular AMD and PCV refractory to anti-VEGF. Switching from aflibercept back to bevacizumab treatment may not be a proper strategy.
关键词： Aflibercept,Polypoidal choroidal vasculopathy,Bevacizumab,Macular degeneration,Anti-vascular endothelial growth factor
更新于2025-09-10 09:29:36