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Background and Objective: To evaluate the efficacy of intravitreal ziv-aflibercept (IVZ) in patients with diabetic macular edema (DME) resistant to intravitreal bevacizumab (IVB)., Patients and Methods: This prospective study was conducted in patients with persistent DME. Patients were switched to IVZ no longer than 6 weeks after the last three consecutive monthly IVB treatments and monitored over a course of 12 weeks. Changes in best-corrected visual acuity (BCVA), central macular thickness (CMT), and macular volume on optical coherence tomography were compared., Results: A total of 59 eyes (38 patients) were included. Mean BCVA improved from 0.84 to 0.71 logMAR (P = .001) after first IVZ treatment and remained significant. In a subgroup analysis, this significance was observed only in the group with baseline visual acuity of less than 20/50. Mean CMT decreased from 479 μm to 364 μm (P = .004) after the first IVZ injections and remained significant., Conclusion: IVZ may be best reserved for patients with persistent DME after initial failure with bevacizumab, with less likelihood for anatomic or functional improvement in those with mild persistent DME. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:145-151.]., (Copyright 2020, SLACK Incorporated.)

Background and Objective: To report the correlation of central macular thickness (CMT) and best-corrected visual acuity (BCVA) after 1-year treatment by two doses (2.5 mg or 1.25 mg) of intravitreal ziv-aflibercept (IVZ) versus bevacizumab (IVB) in eyes with diabetic macular edema (DME)., Patients and Methods: In this study, the correlation of CMT and BCVA changes of the eyes enrolled in a previous clinical trial of 123 eyes were re-evaluated. The correlation of BCVA and CMT changes at each visit was evaluated in the three study arms individually. Then, the eyes in each of the arms were classified at each follow-up visit into three subgroups based on their CMT changes related to the baseline CMT: CMT decrease of 30% or more of baseline CMT, between 10% to 29% of baseline CMT, and less than 9% of baseline CMT or CMT increase., Results: BCVA and CMT changes were correlated significantly (P < .05) in all and in half of the follow-up visits, respectively, in the eyes treated by IVZ 1.25 mg and IVB (r = 0.554 and r = 0.617 at 1 year, respectively). Nevertheless, such a significant correlation was not detected in the eyes treated by IVZ 2.5 mg in any of the follow-up visits (r = 0.202 at 1 year; P = .259). In the IVZ 2.5 mg group, BCVA improvement was observed in all subgroups with each level of CMT reductions., Conclusion: Ziv-aflibercept 2.5 mg might have a beneficial effect on DME beyond thickness reduction. [Ophthalmic Surg Lasers Imaging Retina. 2019;50:684-690.]., (Copyright 2019, SLACK Incorporated.)

Purpose: To evaluate the effect of three intravitreal bevacizumab (IVB) injections alone or in combination with intravitreal erythropoietin (EPO) in the treatment of refractory diabetic macular edema (DME)., Methods: In a randomized double-blind clinical trial, 48 eyes of 34 diabetic patients with refractory DME were enrolled. Eyes were randomly assigned to receive either 3 monthly injections of 0.05 cc (1.25 mg) IVB plus 0.05 cc (1000 unit) EPO or 0.05 cc (1.25 mg) IVB alone. Main outcome was best-corrected visual acuity (BCVA) changes and secondary outcome was central macular thickness (CMT). The patients were followed for 6 months., Results: Mean BCVA changes up to 4 and 6 months were insignificant in both groups. It changed from 0.72 ± 0.56 logMAR at baseline to 0.74 ± 0.5 (P = 0.85) and 0.71 ± 0.44 (P = 0.40) in the combination group and from 0.48 ± 0.39 logMAR to 0.47 ± 0.35 (P = 0.48) and 0.52 ± 0.33 (P = 0.69) in the IVB alone group, at 4 and 6 months, respectively. The difference of mean BCVA changes between the groups was insignificant at both 4 and 6 months (P = 0.07 and P = 0.36, respectively). Within the group changes of mean CMT were significant only in the combination group at 4 and 6 months, from 518 ± 134 μ at baseline to 472 ± 151 to 475 ± 167 μ, respectively (P = 0.01 and P = 0.05). Corresponding changes were not significant in the IVB alone group. However, the difference between the groups was not significant at all visits (P = 0.51 and P = 0.71, respectively)., Conclusions: This clinical trial demonstrated that intravitreal erythropoietin had no additional effect to IVB in the treatment of refractory DME in the short term., Trial Registration: Clinical trials.gov identifier: NCT03821168.

Click here to listen to the Podcast BACKGROUND/AIMS: To compare the efficacy of combined intravitreal injection of bevacizumab and a Rho-kinase inhibitor, fasudil (intravitreal bevacizumab (IVB)/intravitreal fasudil (IVF)), with IVB alone for centre-involving diabetic macular oedema (DME)., Methods: In this prospective randomised clinical trial, 44 eyes with centre-involving DME were randomised into two groups. The combined group received three consecutive injections of IVB (1.25 mg) and IVF (50 µM/L) monthly, while the monotherapy group received only one IVB (1.25 mg) injection per month for 3 months. Changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT) were compared between the two groups at months 3 and 6. The primary outcome measure was the mean change in BCVA at month 6., Results: Mean BCVA was significantly improved in both groups at month 3 (P<0.001), but it persisted up to month 6 only in the IVB/IVF group. Improvement of BCVA was greater in the IVB/IVF group at both time points (P=0.008, P<0.001). In the IVB/IVF and IVB groups, 54.5% versus 10% of the eyes gained≥15 ETDRS letters at month 6 (P=0.026). Between months 3 and 6, mean BCVA significantly decreased by 5±7 ETDRS letters in the IVB group (P=0.002), while no significant deterioration was observed in the IVB/IVF group. Corresponding with the BCVA changes, CMT was significantly reduced in both groups at month 3 (p=0.006, p<0.001) but this reduction sustained only in the IVB/IVF group up to month 6 (p<0.001)., Conclusion: Adjunctive intravitreal injection of a Rho-kinase inhibitor may enhance and prolong the therapeutic effects of anti-vascular endothelial growth factor drugs for centre- involving DME., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose: To evaluate the incidence and risk factors of post-intravitreal injection (IVI) endophthalmitis in a single center modified operating room (OR) setting. Methods: In a retrospective chart review study, patients who underwent IVI in a modified OR between September 2014 and November 2016 were included. Cases of post-IVI endophthalmitis were identified from the Hospital Infection Control Committee records, which tracks all post-procedure infections. Results: 51 472 IVIs (37 814 patients) including 13 658 bilateral simultaneous injections were performed during the study period. There were 17 cases of endophthalmitis (0.033%, 95% CI 0.019%-0.052%). There were no cases of bilateral endophthalmitis. Age, sex, indication for IVI, simultaneous bilateral injections, number of previous injections, and type of injected drug were not significantly associated with incidence of endophthalmitis. Conclusion: Post-IVI endophthalmitis is rare in this modified OR setting. Simultaneous bilateral IVIs and on-site preparation of injections are safe under these conditions.

Purpose: To compare the results of intravitreal bevacizumab (IVB) injection alone or in combination with intravitreal 1 mg triamcinolone acetonide (IVT) in center-involved diabetic macular edema., Methods: In this randomized clinical trial study, ninety-two eyes of 46 patients with bilateral center-involved diabetic macular edema and no previous treatment were included in the study. One eye of each patient was randomly assigned to 1.25 mg of IVB injection or combination of 1.25 IVB and 1 mg IVT. Evaluation of best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP) and grading of lens opacity was conducted at baseline, and weeks 2, 4, 6, 8, 12 and 24 after treatment. Retreatment was performed at a 6-week interval whenever indicated based on CMT., Results: Between the groups, BCVA changes were not statistically different until 24-week follow-up (P > 0.05), but at 24 weeks after treatment, BCVA improvement was significantly better in IVB group (P = 0.049). Significant CMT reduction was observed in each group along the follow-up period (P = 0.001). The mean CMT reduction was more significant in combination (IVB + IVT) group at 2 weeks of follow-up (P < 0.001), but CMT changes were not significant between the groups at weeks 12th and 24th after injection. Overall, retreatment was applied for 59 eyes up to 24 weeks (33 in the IVB group, 26 in the IVB + IVT group). Among patients with 2 or more injections, number of injections was significantly lower in IVB + IVT group (P = 0.043). Three eyes within IVB + IVT group developed IOP rise beyond 21 mmHg, which were controlled with topical anti-glaucoma medications within 1 week. Changes in lens opacity were not significant between two groups., Conclusion: Eyes treated with IVB plus 1 mg IVT injections had more significant reduction in CMT in early post-injection, but this effect was transient. Although after 24 weeks visual acuity improvement was better in IVB group, combination therapy may decrease the number of injections. Combining 1 mg of intravitreal triamcinolone with bevacizumab was not accompanied with significant side effects.

Purpose: This study reports the findings in a large series of patients with acute bacterial endophthalmitis after intravitreal injection of bevacizumab (IVB) in two eye hospitals., Methods: Medical records were reviewed for patients who presented with acute fulminant endophthalmitis in one or two eyes following intravitreal injection of bevacizumab from two separate batches in two eye hospitals., Results: Twenty-eight eyes of 21 patients presented with acute endophthalmitis 12-48 hours after IVB injection. Cultures from the eyes and the vials were positive for E. coli and Citrobacter, each in one of the hospitals. All patients were initially treated with topical, intravitreal, and systemic antibiotics. Twenty-four eyes underwent pars plana vitrectomy. Best corrected visual acuity (BCVA) was 1.27 ± 0.89 logMAR before IVB injecti,on which decreased to 2.80 ± 0.45 LogMAR after presentation of endophthalmitis and 2.12 ± 0.97 logMAR three months after IVB injection. Final visual acuity was found to be no light perception in four eyes., Conclusions: This large outbreak of E.coli and Citrobacter endophthalmitis occurred after intravitreal injection of counterfeit bevacizumab. Visual outcomes were very poor.

The purpose of the study is to compare single injection of intravitreal diclofenac (IVD) with intravitreal bevacizumab (IVB) in the treatment of eyes with naïve diabetic macular edema (DME). In this randomized clinical trial, 57 eyes of 57 patients were randomly assigned to IVD group (30 eyes), cases who received a single intravitreal injection of diclofenac (500 μg/0.1 ml), and IVB group (27 eyes), cases who received a single intravitreal injection of bevacizumab (1.25 mg). Change in best-corrected visual acuity in logMAR at week 12 was the primary outcome measure. Secondary outcomes included changes in central macular thickness, macular leakage, and potential injection-related complications. Best-corrected visual acuity improved significantly more in the IVD group than in the IVB group (P = 0.033), from 0.57 ± 0.25 to 0.49 ± 0.31 versus 0.55 ± 0.24-0.59 ± 0.27 logMAR at 12 weeks, respectively. However, the difference of macular thickness changes was in favor of IVB, but not to a significant level. The amount of change in leakage was not significantly different between the groups either. None of the eyes, in either group, developed ocular hypertension (≥23 mmHg) or cataract progression. No important injection-related complication was observed during the study period. This study demonstrated the superiority of IVD over IVB in the treatment of naïve DME regarding functional, but not anatomical outcomes. Therefore, using IVD as an adjunct or even alternative to other treatments might enhance the functional outcomes in such cases. Further studies are warranted to confirm potential benefit of IVD observed in this study.

Purpose: To evaluate the short-term additive effects of topical ketorolac to intravitreal bevacizumab (IVB) in the management of center-involved diabetic macular edema (CI-DME). Methods: In a randomized double-masked placebo-controlled crossover clinical trial, eyes with CI-DME and the best-corrected visual acuity (BCVA) between (20/40) and (20/400) were included. These eyes should have had at least one intravitreal anti-VEGF injection in the preceding two months. They were randomized into two groups; while both groups received two IVB injections with a six-week interval, one group received topical ketorolac every 6 hr in the first interval and artificial tears every 6 hr as a placebo in the second interval and the other group received the same medications using a crossover method. The main outcome measures were changes in BCVA and central macular thickness (CMT) . Results: Fifty-seven eyes of 35 patients with CI-DME were included in the study. The mean BCVA improvement was --0.09 ± 0.47 logMAR in the periods of receiving ketorolac and --0.03 ± 0.12 logMAR in the periods of placebo treatment, respectively (P = 0.99). Corresponding changes in CMT were --13.1 ±170.1 and +11.7 ±157.7 µm in the ketorolac and placebo periods, respectively (P = 0.322). The treatment effect was not statistically significant regarding both BCVA and CMT changes. Statistical analysis also disclosed that the carryover effect was insignificant for BCVA and CMT. Although the period effect was not significant for BCVA, it was at a meaningful level for CMT changes (P = 0.012). Conclusion: This crossover clinical trial demonstrated that in the course of DME treatment with IVB injections, topical ketorolac did not have any additive beneficial effect at least during a six-week period. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the effect of three intravitreal bevacizumab (IVB) injections alone or in combination with intravitreal erythropoietin (EPO) in the treatment of refractory diabetic macular edema (DME). Methods: In a randomized double-blind clinical trial, 48 eyes of 34 diabetic patients with refractory DME were enrolled. Eyes were randomly assigned to receive either 3 monthly injections of 0.05 cc (1.25 mg) IVB plus 0.05 cc (1000 unit) EPO or 0.05 cc (1.25 mg) IVB alone. Main outcome was best-corrected visual acuity (BCVA) changes and secondary outcome was central macular thickness (CMT). The patients were followed for 6 months. Results: Mean BCVA changes up to 4 and 6 months were insignificant in both groups. It changed from 0.72 ± 0.56 logMAR at baseline to 0.74 ± 0.5 (P = 0.85) and 0.71 ± 0.44 (P = 0.40) in the combination group and from 0.48 ± 0.39 logMAR to 0.47 ± 0.35 (P = 0.48) and 0.52 ± 0.33 (P = 0.69) in the IVB alone group, at 4 and 6 months, respectively. The difference of mean BCVA changes between the groups was insignificant at both 4 and 6 months (P = 0.07 and P = 0.36, respectively). Within the group changes of mean CMT were significant only in the combination group at 4 and 6 months, from 518 ± 134 μ at baseline to 472 ± 151 to 475 ± 167 μ, respectively (P = 0.01 and P = 0.05). Corresponding changes were not significant in the IVB alone group. However, the difference between the groups was not significant at all visits (P = 0.51 and P = 0.71, respectively). Conclusions: This clinical trial demonstrated that intravitreal erythropoietin had no additional effect to IVB in the treatment of refractory DME in the short term. Trial registration: Clinical trials.gov identifier: NCT03821168 [ABSTRACT FROM AUTHOR]

Purpose: This study reports the findings in a large series of patients with acute bacterial endophthalmitis after intravitreal injection of bevacizumab (IVB) in two eye hospitals. Methods: Medical records were reviewed for patients who presented with acute fulminant endophthalmitis in one or two eyes following intravitreal injection of bevacizumab from two separate batches in two eye hospitals. Results: Twenty-eight eyes of 21 patients presented with acute endophthalmitis 12-48 hours after IVB injection. Cultures from the eyes and the vials were positive for E. coli and Citrobacter, each in one of the hospitals. All patients were initially treated with topical, intravitreal, and systemic antibiotics. Twenty-four eyes underwent pars plana vitrectomy. Best corrected visual acuity (BCVA) was 1.27 ± 0.89 logMAR before IVB injecti,on which decreased to 2.80 ± 0.45 LogMAR after presentation of endophthalmitis and 2.12 ± 0.97 logMAR three months after IVB injection. Final visual acuity was found to be no light perception in four eyes. Conclusions: This large outbreak of E.coli and Citrobacter endophthalmitis occurred after intravitreal injection of counterfeit bevacizumab. Visual outcomes were very poor. [ABSTRACT FROM AUTHOR]

Purpose To evaluate the effects of repeated intravitreal injections of bevacizumab ( IVB) versus triamcinolone acetonide ( IVT) in the treatment of acute central retinal vein occlusion ( CRVO). Methods In this randomized clinical trial, 86 eyes with recent onset (<12 weeks) CRVO were assigned to two groups: IVB group (43 eyes) that received three monthly injections of 1.25 mg of IVB, and IVT group (43 eyes) that received two injections of 2 mg IVT 2 months apart. Outcomes were best-corrected visual acuity ( BCVA), central macular thickness ( CMT), and intraocular pressure ( IOP) changes. Results Mean BCVA improved significantly at 6 months in both groups; from 0.87 ± 0.49 to 0.41 ± 0.35 log MAR in IVB group, and from 0.81 ± 0.45 to 0.62 ± 0.48 log MAR in IVT group (p < 0.001). However, between-group differences reach a significant level at months 4 (p = 0.003) and 6 (p < 0.001) in favour of the IVB group. In terms of CMT reduction, the difference between the groups was statistically significant (p = 0.002) at month 6. Significant differences were noted more in the ischaemic cases in favour of the IVB group. Mean IOP rise was significantly higher in the IVT group at all visits. Conclusions Both 3-times monthly IVB injections and 2-times IVT injections could be effective in cases with recent onset CRVO up to 6 months. However, considering the better outcomes after IVB injections and the potential complications of IVT injections, we would recommend prescheduled repeated IVB injections for such cases. The observed favourable responses were more pronounced in the ischaemic types; nevertheless, this should be confirmed in larger studies. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the effects of repeated intravitreal injections of bevacizumab (IVB) versus triamcinolone acetonide (IVT) in the treatment of acute branch retinal vein occlusion (BRVO). Methods: In this randomized clinical trial, 86 eyes with recent-onset (less than 12 weeks) BRVO were included. Participants were randomly assigned to two treatment groups: (1) IVB group (43 eyes), patients who received three monthly injections of 1.25 mg of IVB, and (2) IVT group (43 eyes), patients who received two injections of 2 mg IVT 2 months apart. Patients were examined at 1, 2, 3, 4, and 6 months after enrollment. Main outcome measure was change in best-corrected visual acuity (BCVA) at 6 months. Secondary outcome measures were central macular thickness (CMT) and intraocular pressure (IOP) changes at month 6. Results: Mean BCVA improved significantly up to 6 months in both groups from 0.68 ± 0.25 to 0.31 ± 0.21 logMAR (logarithm of minimum angle of resolution) in the IVB group, and from 0.67 ± 0.29 to 0.46 ± 0.31 logMAR in the IVT group ( P < 0.001 for both). However, between-group differences reach to a significant level at months 4 ( P = 0.013) and 6 ( P < 0.001) in favor of the IVB group. In terms of CMT reduction, similarly, both groups showed a significant decrease at months 3 and 6, and the differences between the groups were statistically significant ( P = 0.031) at final visit. Dividing the cases into ischemic and non-ischemic types, a significant difference was noted only in the ischemic cases regarding BCVA improvement and CMT reduction in favor of the IVB group. Mean IOP rise was significantly higher in the IVT group at all visits. Conclusions: Both 3-times-monthly IVB injections and 2-times IVT injections with a 2-month interval could be effective for improving BCVA and CMT in cases with recent-onset BRVO up to 6 months. However, considering the better visual and anatomic outcomes after IVB injections and the potential complications of IVT injections, we would recommend prescheduled repeated IVB injections for such cases. The favorable responses were more pronounced in the ischemic types of BRVO in this trial; nevertheless, this should be confirmed in larger studies. [ABSTRACT FROM AUTHOR]

Purpose: To report the long-term results of intravitreal bevacizumab (Avastin) therapy for choroidal neovascularization (CNV) secondary to non-age-related macular degeneration (non-AMD). Methods: This prospective interventional case series was conducted on patients with non-AMD CNV. All patients received 1.25 mg intravitreal bevacizumab and were followed for at least 18 weeks. Indications for retreatment were decreased visual acuity or recurrence of subretinal fluid or hemorrhage associated with leakage on fluorescein angiography. Primary outcome measures were changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT). Secondary outcome measures consisted of any adverse event related to the therapy. Results: The study included 31 eyes of 28 patients with non-AMD CNV including idiopathic (n=11), due to myopia (n=7), angioid streaks (n=5), and other disorders (n=8). Mean initial BCVA was 20/100 which improved to 20/60 at 6 weeks; 20/40 at 12, 18, 24, and 36 weeks; and 20/30 at 54 weeks. Serial optical coherence tomography measurements showed mean CMT of 288 μm at baseline, which was decreased to 209 μm at last visit (P=0.95). There was no correlation between the underlying disease and changes in BCVA during the follow-up period. Conclusion: Intravitreal bevacizumab significantly improved visual acuity in eyes with non-AMD CNV due to various etiologies. [ABSTRACT FROM AUTHOR]

Purpose: To compare the results of intravitreal bevacizumab (IVB) injection alone or in combination with intravitreal triamcinolone acetonide (IVT) versus macular laser photocoagulation (MPC) as a primary treatment of diabetic macular edema (DME). Design: Randomized 3-arm clinical trial. Participants: A total of 150 eyes of 129 patients with clinically significant DME and no previous treatment. Methods: The eyes were randomly assigned to 1 of the 3 study arms: the IVB group, patients who received 1.25 mg IVB (50 eyes); the IVB/IVT group, patients who received 1.25 mg of IVB and 2 mg of IVT (50 eyes); and the MPC group, patients who underwent focal or modified grid laser (50 eyes). Retreatment was performed at 12-week intervals whenever indicated. Main Outcome Measures: Change in best-corrected visual acuity (VA) at week 24. Results: VA changes among the groups were statistically significant at 6 (P<0.001) and 24 (P = 0.012) weeks. The significant treatment effect was demonstrated in the IVB group at all follow-up visits and in the IVB/IVT group at 6 and 12 weeks. VA changes ± standard deviation at 36 weeks were −0.28±0.25, −0.04±0.33, and +0.01±0.27 logarithm of minimum angle of resolution in the IVB, IVB/IVT, and MPC groups, respectively (P = 0.053). Significant central macular thickness (CMT) reduction was observed in all groups only up to 6 weeks; however, CMT changes were not significant among the groups in all visits. Overall, retreatment was required for 27 eyes up to 36 weeks (14 in the IVB group, 10 in the IVB/IVT group, and 3 in the MPC group). In the IVB group, in which a greater VA improvement was observed, only 1 injection was required in 72% of the cases. VA improvement >2 Snellen lines at 36 weeks was detected in 37%, 25%, and 14.8% of patients in the IVB, IVB/IVT, and MPC groups, respectively. Conclusions: Intravitreal bevacizumab injection in patients with DME yielded a better visual outcome at 24 weeks compared with macular photocoagulation. A change in CMT beyond the 6-week time point that corresponded to the vision change was not detected. No adjunctive effect of IVT was demonstrated. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. [Copyright &y& Elsevier]