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- ItemSomente MetadadadosComparison of two doses of intravitreal bevacizumab (Avastin) for treatment of macular edema secondary to branch retinal vein occlusion: Results from the Pan-American collaborative retina study group at 6 months of follow-up(Lippincott Williams & Wilkins, 2008-02-01) Wu, Lihteh; Arevalo, Jose Fernando; Roca, Jose Antonio; Maia, Mauricio [UNIFESP]; Berrocal, Maria Hortensia; Rodriguez, Francisco J.; Evans, Teodoro; Costa, Rogerio Alves [UNIFESP]; Cardillo, José Augusto [UNIFESP]; PACORES; Inst Cirugia Ocular; Clin Oftalmol Ctr; Clin Ricardo Palma; Universidade Federal de São Paulo (UNIFESP); Univ Puerto Rico; Univ Rosario; Hosp Olhos AraraquaraPurpose: To report the 6-month anatomical and visual outcomes after injecting two different doses of intravitreal bevacizumab in patients with macular edema secondary to branch retinal vein occlusion (BRVO).Methods: An interventional, retrospective multicenter study of 45 eyes that were treated with at least one intravitreal injection (24 eyes, 1.25 mg; 21 eyes, 2.5 mg) of bevacizumab is reported. The main outcome measures were the central 1-mm macular thickness (CMT) and the change in ETDRS lines of best-corrected visual acuity (BCVA) at 6 months.Results: Forty-five eyes were injected on average 26.1 months (range, 3-86 months) after the diagnosis. The average follow-up was 35.2 weeks (range, 24-52 weeks). All patients completed at least 6 months of follow-up. In the 1.25-mg dose group, at 1 month, there was an average gain of 4.5 lines of BCVA; at 3 months, 5.1 lines of BCVA; and at 6 months, 5.1 lines of BCVA (P < 0.005). In the 2.5-mg dose group, at 1 month, there was an average gain of 2.3 lines of BCVA; at 3 months, 3.8 lines of BCVA; and at 6 months, 4.8 lines of BCVA (P = 0.05). In the 1.25-mg dose group, the mean CMT +/- SD decreased from 461 +/- 211 mu m at baseline to 321 +/- 152 mu m at 1 month, 273 +/- 99 mu m at 3 months, and 277 +/- 114 mu m at 6 months (P = 0.0002). In the 2.5-mg group, the mean CMT +/- SD decreased from 385 +/- 168 mu m at baseline to 279 +/- 111 mu m at 1 month, 249 +/- 97 mu m at 3 months, and 240 +/- 93 mu m at 6 months (P = 0.011).Conclusion: There were no statistically significant differences between the two dose groups with regard to the number of injections and anatomical and functional outcomes. Intravitreal injection of bevacizumab at doses up to 2.5 mg appears to be effective in improving BCVA and reducing CMT in BRVO in the short term. Multiple injections are needed in a large number of eyes for continued control of macular edema and preservation of visual acuity in the short term. Longer studies are needed to determine what role if any intravitreal injection of bevacizumab may play in the long-term treatment of this condition.
- ItemSomente MetadadadosComparison of two doses of intravitreal bevacizumab as primary treatment for macular edema secondary to branch retinal vein occlusions: results of the Pan American Collaborative Retina Study Group at 24 months(Lippincott Williams & Wilkins, 2009-11-01) Wu, Lihteh; Arevalo, Jose Fernando; Berrocal, Maria Hortensia; Maia, Mauricio [UNIFESP]; Roca, Jose Antonio; Morales-Canton, Virgilio; Alezzandrini, Arturo A.; Diaz-Llopis, Manuel Jose; Inst Cirugia Ocular; Ctr Caracas; Univ Puerto Rico; Universidade Federal de São Paulo (UNIFESP); Clin Ricardo Palma; Hosp Luis Sanchez Bulnes; Univ Buenos Aires; Inst Oftalmol ValenciaPurpose: The purpose of this study was to compare the injection burden, central macular thickness (CMT), and change in best-corrected visual acuity (BCVA) after injecting 1.25 mg or 2.5 mg of bevacizumab as needed in patients with primary macular edema secondary to branch retinal vein occlusion.Methods: An interventional, retrospective, comparative multicenter study was conducted of 63 eyes with macular edema secondary to branch retinal vein occlusion that were treated primarily with intravitreal bevacizumab (38 eyes, 1.25 mg; 25 eyes, 2.5 mg). The main outcome measures were the CMT and the change of BCVA at 24 months.Results: All patients completed at least 24 months of follow-up. The mean number of injections per eye was 3.6 in the 1.25-mg group and 4.3 in the 2.5-mg group (P = 0.4770). At 24 months, in the 1.25-mg group, the logarithm of the minimum angle of resolution BCVA improved from baseline 0.38 +/- 0.63 (P < 0.0001) units to 0.64 +/- 0.6 units for the 2.5-mg group (P < 0.0001). In the 1.25-mg group, 26 (68%) eyes gained >= 3 of Early Treatment of Diabetic Retinopathy Study visual acuity and 2 (5%) eyes lost >= 3 lines of Early Treatment of Diabetic Retinopathy Study visual acuity. In the 2.5-mg group, 18 (72%) eyes improved >= 3 of Early Treatment of Diabetic Retinopathy Study visual acuity, and none of the eyes lost >= 3 lines of Early Treatment of Diabetic Retinopathy Study visual acuity. The CMT in the 1.25-mg group improved from 453 +/- 140 mu m to 244 +/- 125 mu m (P < 0.0001) versus 444 +/- 175 mu m to 234 +/- 80 mu m in the 2.5-mg group (P < 0.0001). There were no cases of endophthalmitis. No systemic adverse events were reported.Conclusion: Intravitreal bevacizumab at doses up to 2.5 mg seems to be effective in improving BCVA and reducing CMT in macular edema secondary to branch retinal vein occlusion. No statistically significant differences were found between the two dose groups with regard to the number of injections, CMT, and change in BCVA. RETINA 29:1396-1403, 2009
- ItemSomente MetadadadosCOMPARISON of TWO DOSES of INTRAVITREAL BEVACIZUMAB AS PRIMARY TREATMENT for MACULAR EDEMA SECONDARY TO CENTRAL RETINAL VEIN OCCLUSION Results of the Pan American Collaborative Retina Study Group at 24 Months(Lippincott Williams & Wilkins, 2010-07-01) Wu, Lihteh; Arevalo, J. Fernando; Berrocal, Maria H.; Maia, Mauricio [UNIFESP]; Roca, Jose A.; Morales-Canton, Virgilio; Alezzandrini, Arturo A.; Diaz-Llopis, Manuel J.; Inst Cirugia Ocular; Clin Oftalmol Ctr Caracas; Univ Puerto Rico; Universidade Federal de São Paulo (UNIFESP); Clin Ricardo Palma; Hosp Luis Sanchez Bulnes; Univ Buenos Aires; Inst Oftalmol ValenciaPurpose: the purpose of this study was to compare the injection burden, central macular thickness (CMT), and change in best-corrected visual acuity after injecting 1.25 mg or 2.5 mg bevacizumab as needed in patients with primary macular edema secondary to central retinal vein occlusion.Methods: This is an interventional, retrospective, comparative multicenter study of 86 eyes with macular edema secondary to central retinal vein occlusion that were treated primarily with intravitreal bevacizumab (44 eyes, 1.25 mg; 42 eyes, 2.5 mg). the main outcome measures were the CMT and the change of best-corrected visual acuity at 24 months.Results: All patients completed at least 24 months of follow-up. the mean number of injections per eye were 7.2 for the 1.25-mg dose group and 8.1 for the 2.5-mg dose group (P = 0.4492). At 24 months, in the 1.25-mg dose group, the logarithm of the minimal angle of resolution best-corrected visual acuity improved from baseline 0.35 +/- 6 0.57 units (P < 0.0001) versus 0.27 +/- 0.68 units for the 2.5-mg dose group (P < 0.0001). These differences were not statistically significant between both dose groups. in the 1.25-mg dose group, 25 (56.8%) eyes gained >= 3 lines of Early Treatment of Diabetic Retinopathy Study visual acuity and 6 (13.6%) lost >= 3 lines of Early Treatment of Diabetic Retinopathy Study visual acuity. in the 2.5-mg dose group, 24 (57.1 %) eyes improved >= 3 lines of Early Treatment of Diabetic Retinopathy Study visual acuity and 7 (16.7%) lost >= 3 lines of Early Treatment of Diabetic Retinopathy Study visual acuity. the CMT in the 1.25-mg dose group improved from 635 +/- 324 mu m to 264 +/- 160 mu m (P < 0.0001) versus 528 +/- mu m to 293 +/- 137 mu m in the 2.5-mg dose group (P < 0.0001). There was no statistically significant difference between both dose groups with regard to the CMT reduction.Conclusion: Intravitreal bevacizumab at doses up to 2.5 mg seems to be effective in improving visual acuity and reducing CMT in macular edema secondary to central retinal vein occlusion. There were no statistically significant differences between the two dose groups with regard to the number of injections, CMT, and change in visual acuity. RETINA 30:1002-1011, 2010
- ItemSomente MetadadadosEmerging pharmacotherapies for diabetic macular edema(Informa Healthcare, 2007-11-01) Furlani, Bruno A.; Meyer, Carsten H.; Rodrigues, Eduardo B.; Maia, Mauricio; Farah, Michel E. [UNIFESP]; Penha, Fernando M.; Holz, Frank G.; Univ Bonn; Universidade Federal de São Paulo (UNIFESP)Diabetic macular edema (DME) is the most frequent cause of severe vision impairment in patients with non-proliferative diabetic retinopathy. Even though patients should achieve optimal glycemic control, normalization of blood pressure and serum lipids, as well as improvement of cardiac and renal status, these measures alone will not prevent every patient from developing visual loss caused by DME. the goal of local treatment for DME is vision improvement, usually achieved after reducing leakage on fluorescein angiography (FA) and retinal thickness on optical coherence tomography (OCT). Laser photocoagulation is still the standard treatment for clinically significant DME. However, laser photocoagulation rarely provides major visual improvement, especially in patients with diffuse DME. Thus, a therapeutic intervention that restores visual acuity impaired by DME more often remains a significant unmet medical need. This review aims to present the most important emerging drug technologies for therapy of DME at present, including corticosteroids, vascular endothelial growth factor inhibitors, protein kinase C inhibitors, small interfering RNA, hydroxy-3-methyl-glutaryl coenzyme A reductase inhibitors and non-hormonal anti-inflammatory agents. Recent progress in this field suggests that local management of DME may change rapidly in the near future. Novel emerging drugs should enable better anatomical and functional outcomes for therapy of this sight-threatening disease.
- ItemAcesso aberto (Open Access)Ensaio clínico randomizado multicêntrico para avaliar a eficácia de injeções intravítreas de bevacizumabe, triancinolona ou de sua combinação no tratamento do edema macular diabético(Universidade Federal de São Paulo (UNIFESP), 2015-07-31) Oliveira Neto, Hermelino Lopes de [UNIFESP]; Mattos Junior, Rubens Belfort [UNIFESP]; Universidade Federal de São Paulo (UNIFESP)In diabetic patients, it is estimated that the risk of blindness is twenty times higher than the normal population and approximately 19% of blindness in the world are caused by diabetes mellitus (DM). In Brazil, diabetic retinopathy (DR), a specific microvascular complication, is among the leading causes of irreversible blindness, affecting 7.6% of the population according to the Ministry of Health, and this disease accounts for 4.6% of severe visual impairments. The diabetic macular edema (EMD) is the primary mechanism for vision lossin patients with non-proliferative DR. It arises due to secondary formation of micro aneurysms, changes in the blood-retinal barrier, increasedinflammation and angigenic factors that promote increase in thevascular permeability abd consequent leakage of fluid and lipids to the retina. The EMD treatment includes laser photocoagulation, intravitreal injection of anti-angiogenic drugs or steroids.The aim of this study was to evaluate and compare the efficacy and adverse effects of intravitreous injections of bevacizumab, triancinolone or their combination in the treatment of clinically significant diabetic macular edema through tests of visual acuity and IOP measurements and central macular thickness. This study included142 patients with diabetic retinopathy and clinically significant macular edema from eight cities. It is a randomized, multicenter and masked study. Patients underwent ophthalmologic examination and optical coherence tomography (OCT). Afterwards they were divided into three treatment groups: (1) Bevacizumab-1.25mg /0.05ml; (2) triamcinolone-4mg /0.1ml; (3) Bevacizumab+triancinolone. The obtained average age was 58.8 years for the BEVACIZUMABE group, 57.1 years for the TRIANCINOLONE group and 61years for BEVACIZUMABE+TRIANCINOLONE group(p =0.716). We observed statistically significant improvement in visual acuity (>4lines) in all groups, comparing the results of week 24 with the baseline visit. At week 24 there was no significant difference in the visual acuity between the 3 groups (p =0.436). It was observed reduction in macular thickness in all thegroups (BEVACIZUMABE=103?m, TRIANCINOLONE=160 micrometres BEVACIZUMABE TRIANCINOLONE+=125um), and the TRIANCINOLONE group showed significantly less thick(247 microns) than the bevacizumab group (287 microns). In all groups, there was an IOP increase, and the TRIANCINOLONE group had higher mean value of IOP throughout the study period (18 mmHg) .The average number of injections was higher in the BEVACIZUMABE group (3.2 injections), followed by BEVACIZUMABE+TRIAMCINOLONE (2.4 injections) and TRIANCINOLONA (2.1injections) group.In this investigation no severe adverse event was observed. At the end of the study, there was no significant difference between the groups regarding the visual acuity, intraocular pressure and central macular thickness.