Consecutive Monthly Injections Research Articles

Three-month outcomes of treatment with faricimab or aflibercept for neovascular age-related macular degeneration: a propensity score matching study in a Japanese population.

This study aimed to compare the treatment outcomes of patients with neovascular age-related macular degeneration (nAMD) who initially received faricimab or aflibercept treatment using propensity score matching (PSM) to align patient backgrounds. Patients with treatment-naïve nAMD who received either faricimab or aflibercept for three consecutive monthly injections as the loading phase were enrolled in this study. In the 1:1 PSM, sex, age, best-corrected visual acuity (BCVA), central macular thickness (CMT), central choroidal thickness (CCT), and AMD subtypes in the pre-treatment state were selected as covariates. We examined the BCVA, CMT, CCT, and remaining fluid at 1-, 2-, and 3-month after the first injection. After PSM, 43 eyes were included in the faricimab and aflibercept group each. Both groups showed significant improvements in BCVA, CMT, and CCT at 1-, 2-, and 3-month after the initial injection compared with baseline. Meanwhile, no significant differences were observed between the two groups at any time point regarding BCVA, CMT, and CCT. At 1-month, 18.6% of patients in the faricimab group and 41.9% in the aflibercept group demonstrated residual subretinal fluid or intraretinal fluid, with a significant difference between the groups (P = 0.03). The BCVA improved after three loading injections of both faricimab and aflibercept. Faricimab may provide a favorable early treatment response in reducing subretinal fluid in a Japanese cohort.

Topical Dorzolamide as Adjunctive Treatment With Intravitreal Bevacizumab in Bilateral Diabetic Macular Edema.

Intravitreal injection of anti-vascular endothelial growth factor (VEGF) agents is accepted as the gold standard treatment for center-involving diabetic macular edema (CI-DME). Adjunctive administration of topical dorzolamide may enhance the therapeutic effects of anti-VEGF agents. In this study, we compared the efficacy of topical dorzolamide plus intravitreal injection of bevacizumab (IVB) versus IVB alone in patients with bilateral DME. This prospective, randomized contralateral eye study was carried out in a tertiary referral ophthalmology center, Al-Zahra Eye Hospital, Zahedan, Iran, between April 2021 and April 2022. Thisstudy included 50 eyes of 25 patients with bilateral DME. All eyes received three consecutive monthly injections of IVB. For each patient, one eye was randomized to instill dorzolamide eye drops three times a day as an intervention, and the other received artificial tear drops as a placebo. Best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP) were evaluated before starting treatment and then monthly for the first three months. Among 25 included patients, the average age was 56.64 ± 7.97 years, and 48% were female. BCVA did not improve significantly in any groups (P > 0.05). No significant difference was observed in terms of BCVA between the intervention and control groups (P > 0.05). The present study showed a decrease in CMT in both study groups (P < 0.05). At month 3, the decrease in mean CMT from baseline was significantly higher in eyes receiving topical dorzolamide compared to the control group (-88.92 ± 82.90 vs. -37.64 ± 86.16 µM, respectively; P = 0.037). IOP decreased significantly only in eyes receiving dorzolamide (P < 0.001). The results of the present study indicate that adjunctive administration of topical dorzolamide has a beneficial effect on CMT reduction from baseline, but it did not have an additive effect on BCVA improvement compared to IVB monotherapy.

Comparison of functional and morphologic changes between brolucizumab and faricimab in neovascular age-related macular degeneration.

This study aimed to compare functional and morphologic changes in the loading phase between patients with treatment-naïve macular neovascularization (MNV) due to neovascular age-related macular degeneration (nAMD) treated with either intravitreal brolucizumab (IVBr) or intravitreal faricimab (IVF) injections in a clinical setting. We retrospectively studied 92 consecutive eyes of 90 patients with neovascular nAMD who were scheduled to receive IVBr (42 eyes of 41 patients) or IVF (50 eyes of 49 patients) injections between October 2021 and December 2022. All patients received three consecutive monthly injections of 6.0 mg/0.05 mL brolucizumab or 6.0 mg/0.05 mL faricimab. The best-corrected visual acuity (BCVA), central foveal thickness (CFT), and central choroidal thickness (CCT) at baseline and 1, 2, and 4 months after the initial treatment were measured and compared between the groups. Thirty-seven eyes in IVBr group and forty-seven eyes in IVF group who finished treatments in the loading phase were assessed at the follow-up examination. The BCVA, CFT, and CCT changed significantly after loading phase in both groups (P < 0.05 for both comparisons). The IVBr group had more rapid improvement of the BCVA (P = 0.037) at 1 month than the IVF group, but there was no difference at 4 months (P = 0.367). The CFT and CCT decreases tended to be greater in the IVBr group than in the IVF group throughout the follow-up period. Of the five eyes excluded from the IVBr group, one eye (2.4%) each had intraocular inflammation (IOI) and was a non-responder, and two eyes (4.8%) had retinal pigment epithelial tears after treatment. Of the three eyes excluded from the IVF group, two eyes (4.0%) did not respond to the treatment. Both IVBr and IVF injections were well-tolerated and improved the VA in treatment-naïve patients with MNV due to nAMD after a loading phase, although IVBr caused a trend towardfaster visual improvements in the BCVA. The IVBr group also had greater reductions of the CFT and CCT than the IVF group. However, the potential for adverse events and no response to treatment with each drug are considerations.

Clinical outcomes of different regimens of intravitreal Conbercept for the treatment of choroidal neovascularization secondary to pathological myopia.

To assess the clinical outcomes of two intravitreal injection regimens of Conbercept used to treat choroidal neovascularization secondary to pathological myopia (PM-CNV). A total of 72 eyes of 72 patients were treated: 39 eyes received a single injection followed by treatment pro re nata (1 + PRN); 33 eyes first received 3 consecutive monthly injections (3 + PRN) then followed by PRN. After initial injection, patients were followed up for 12months. The mean age of 72 patients was 45.3 ± 5.1years, with the mean diopter of -10.62 ± 3.24D. The best corrected visual acuity (BCVA) was 0.86 ± 0.23 LogMAR with 1 + PRN and 0.90 ± 0.19 LogMAR with 3 + PRN at baseline (P = 0.422), 0.36 ± 0.07 and 0.33 ± 0.05 LogMAR at month 3 (P = 0.026); and 0.33 ± 0.03 and 0.32 ± 0.02 LogMAR at month 12 (P = 0.096). The central retinal thickness (CRT) was 333.5 ± 22.7μm with 1 + PRN and 341.2 ± 20.9μm with 3 + PRN at baseline (P = 0.139), 281.53 ± 10.28 and 273.15 ± 13.24μm at month 3 (P = 0.004); 266.83 ± 8.14 and 264.91 ± 9.27μm at month 12 (P = 0.350). The number of injections in the 1 + PRN group was significantly lower than that observed in the 3 + PRN group (2.15 ± 1.06 versus 3.36 ± 0.74; P < 0.001). During the follow-up, no serious ocular complications and adverse reactions related to Conbercept and injections occurred. Both injection regimens resulted in similar visual outcomes in PM-CNV patients. The 1 + PRN regimen had fewer injections and might be more suitable in this patient population.

Aflibercept for Diabetic Macular Edema in Real-Life Practice in GREece: Three-Year Outcomes of the ADMIRE Study

ABSTRACT Purpose To evaluate the efficacy and safety of intravitreal aflibercept injections for diabetic macular edema (DME) treatment in a tertiary referral center in Greece. Methods ADMIRE was a prospective, observational cohort study of patients with DME. Efficacy was assessed by change in best-corrected visual acuity (BCVA) and central subfield thickness (CST) from baseline to month 36 after treatment with intravitreal aflibercept in treatment-naive patients and previously treated patients. Safety was evaluated by recording any patients-reported events. Results Participants in the study were 94 patients with DME, 70 treatment naive and 24 previously treated with ranibizumab. At month 36 of the follow-up period, the mean change in BCVA was +7.4 letters compared to baseline (p < .001). The mean change in BCVA in treatment-naive patients was +8.9 letters and differed significantly compared to previously treated patients (+5.9 letters, p = .041). In addition, patients who received a loading dose of 5 monthly injections at the initiation of treatment provided better VA outcomes (+11.4 vs. +6.1 letters, p < .001). Accordingly, the mean CST at month 36 (369.6 ± 72.8 μm) was significantly decreased compared to baseline (479.2 ± 68.3 μm, p < .001). Overall, the mean number of injections at month 36 was 13.4. Safety analysis showed that the reported ocular adverse events during the 36-month study period were mild and not sight-threatening. Conclusion Intravitreal aflibercept was found to be safe and effective for the treatment of DME in real-life in a Greek population. Treatment-naive patients and those who received a loading dose of five consecutive monthly injections at initiation of treatment exhibited better outcomes, suggesting that early and effective treatment may prevent vision loss.

Aflibercept more effectively weans patients with neovascular age-related macular degeneration off therapy compared with bevacizumab.

BACKGROUNDStudies assessing the efficacy of therapies for neovascular age-related macular degeneration (nvAMD) have demonstrated that aflibercept may have a longer treatment interval than its less-expensive alternative, bevacizumab. However, whether this benefit justifies the additional cost of aflibercept remains under debate. We have recently reported that a treat-and-extend-pause/monitor approach can be used to successfully wean 31% of patients with nvAMD off anti-VEGF therapy. Here, we examined whether the choice of therapy influences the outcomes of this approach.METHODSIn this retrospective analysis, 122 eyes of 106 patients with nvAMD underwent 3 consecutive monthly injections with either aflibercept (n = 70) or bevacizumab (n = 52), followed by a treat-and-extend protocol, in which the decision to extend the interval between treatments was based on visual acuity, clinical exam, and the presence or absence of fluid on optical coherence tomography. Eyes that remained stable 12 weeks from their prior treatment were given a 6-week trial of holding further treatment, followed by quarterly monitoring. Treatment was resumed for worsening vision, clinical exam, or optical coherence tomography findings.RESULTSAt the end of 1 year, eyes receiving bevacizumab had similar vision but required more injections (8.7 ± 0.3 treatments vs. 7.2 ± 0.3 treatments) compared with eyes receiving aflibercept. However, eyes treated with aflibercept were almost 3 times more likely to be weaned off treatment (43% vs. 15%) compared with eyes treated with bevacizumab at the end of 1 year.CONCLUSIONThese observations expose an advantage of aflibercept over bevacizumab and have important clinical implications for the selection of therapy for patients with nvAMD.FUNDINGThis work was supported by the National Eye Institute, NIH grants R01EY029750 and R01EY025705, Research to Prevent Blindness, the Alcon Young Investigator Award from the Alcon Research Institute, and the Branna and Irving Sisenwein Professorship in Ophthalmology.

Comparison of the effects of 3 different anti-VEGF drugs on cornea thickness, lens thickness and anterior chamber depth

To compare the long-term effects of 3 different anti-VEGF molecules on the lens, cornea and anterior chamber in phakic patients who have received consecutive intravitreal injections. 157 patients who did not have corneal pathology but were treated with 1.25mg/0.05ml intravitreal bevacizumab, 0.5mg/0.5ml ranibizumab or 2mg/0.05ml aflibercept injections due to diabetic macular edema were retrospectively analyzed in our clinic. Patients who received three consecutive monthly injections were included to the study. Corneal thickness, lens thickness and anterior chamber depth measurements which were taken before the injections, 1 month after the first injection, 1 month after the second injection, and 1 month after the third injection were used in the study. There was no statistical difference between the bevacizumab, ranibizumab, aflibercept and control group in terms of preoperative specifications such as number of patients, gender and age average. A statistically significant difference was found between the 4 anterior chamber depth measurements in the control group, Ranibizumab drug group, and Bevacizumab and Aflibercept drug groups (p&lt;0.001, p=0.026; p=0.07, p&lt;0.001, respectively). Anterior chamber depth of the Ranibizumab and Bevacizumab patients decreased in the first month and increased in the second and third months. However, anterior chamber depth of the Aflibercept patients increased over time. As a result of our study; we concluded that three different anti- VEGF drug molecules have an effect on the anterior camera.

Response to Initial Anti-Vascular Endothelial Growth Factor for Diabetic Macular Edema Is Significantly Correlated with Response to Third Consecutive Monthly Injection.

To determine whether the response to the initial anti-vascular endothelial growth factor (anti-VEGF) injection to treat diabetic macular edema (DME) is significantly correlated with the response to the third consecutive monthly injection of the same anti-VEGF agent. Seventy eyes with DME that were treated with an anti-VEGF agent (16 eyes with 1.25-mg bevacizumab, 35 eyes with 0.5-mg ranibizumab, and 19 eyes with 2.0-mg aflibercept) were studied. They were treated with three consecutive monthly injections of one of the three anti-VEGF agents. The best-corrected visual acuity (BCVA) in the logarithm of the minimum angle of resolution (logMAR units) and the central macular thickness (CMT) were measured at the baseline, 1 week after the initial injection, and 1 month after the third consecutive monthly injection. The changes of both values from the baseline 1 week after the initial injection (day 7) and 1 month after the third monthly injection were determined. The significance of the correlations between the BCVA and the CMT was determined. The mean BCVA improved significantly for all three agents (0.38 ± 0.22 logMAR units at the baseline to 0.27 ± 0.25 logMAR units) after the three monthly injections (p &lt; 0.05, repeated ANOVA). For all cases, a moderate but significant correlation was found between the BCVA at day 7 and 1 month after the third injection (r = 0.58, p &lt; 0.01; Spearman's rank correlation). No significant correlation was found for bevacizumab (r = 0.09, p = 0.73), moderate correlation was found for ranibizumab (r = 0.42, p &lt; 0.05), and a strong correlation was found for aflibercept (r = 0.83, p &lt; 0.001) between the BCVA at day 7 and at 1 month after the third injection. The mean CMT improved significantly for all three agents (481.9 ± 96.3 μm at the baseline to 364.1 ± 116.0 μm after the three monthly injections, p &lt; 0.05), and a moderate correlation was found for the three agents between CMT at day 7 to that at one month after the third anti-VEGF injection (r = 0.54, p &lt; 0.01). A moderate correlation was found for all three agents between CMT at day 7 to that at one month after the third anti-VEGF injection (r = 0.68 for bevacizumab, r = 0.41 for ranibizumab and r = 0.53 for aflibercept, p &lt; 0.05). The significant correlations between the results on day 7 to that one month after the third anti-VEGF treatment for DME indicates that the long-term effects of anti-VEGF therapy can be predicted by the short-term response. In addition, the results indicate that there may be differences in the effectiveness between the three anti-VEGF agents.

Real-world efficacy of galcanezumab for the treatment of migraine in Korean patients

We aimed to provide real-world data on the effectiveness of an anti-calcitonin gene-related peptide monoclonal antibody administered for treating migraine in Korean patients. We prospectively recruited patients with migraine who received galcanezumab treatment at a single university hospital from June 2020 to April 2021. The treatment response was assessed after three consecutive monthly injections. A 50% responder rate was evaluated based on ≥50% reduction in the number of moderate/severe headache days. Overall, 87 patients were included in the analysis. Most patients were women (83.9%). They had a mean age of 41.7 ± 12.3 years (range 17-72). Sixty-five patients (74.7%) had chronic migraine, 35 patients (40.2%) had a history of medication-overuse headache, and 32 patients (36.8%) were previously unresponsive to or found intolerable five classes of preventive medication. After three months of treatment, mean changes in numbers of monthly headache days, moderate/severe headache days, crystal clear days, and days of acute medication use were -7.2 ± 8.43, -4.3 ± 9.76, 7.3 ± 8.50, and -4.1 ± 7.93, respectively. The 50% responder rates were 58.3%, 44.2%, and 40.6% for patients with unsuccessful previous use of 0-1, 2-4, and 5 preventive medication classes, respectively. Headache Impact Test-6 and Migraine Disability Assessment Test scores also decreased (-4.4 ± 8.09 and -32.9 ± 77.04, respectively). In our cohort, the effectiveness and safety of galcanezumab were comparable with those reported in clinical trials, whereas a higher response rate was observed in the difficult-to-treat patient subset than that reported in trials. We provide real-world evidence of galcanezumab treatment benefits in Asian patients with migraine.

Effectiveness of microperimetry in evaluating anti-vascular endothelial growth factor therapy for diabetic macular edema patients with relatively good vision: A retrospective observational study.

No studies have evaluated the retinal sensitivity (RS) for diabetic macular edema (DME) patients with good vision. Therefore, this study aimed to determine the effectiveness of microperimetry in evaluating the effectiveness of anti-vascular endothelial growth factor (anti-VEGF) treatment for DME patients with relatively good vision.Twenty-seven eyes of 27 patients (mean age, 61.3 ± 11.2 years) with DME and decimal best-corrected visual acuity (BCVA) ≥0.6 were studied. All patients received 3 consecutive monthly injections of intravitreal anti-VEGF agents. The BCVA, central subfield macular thickness (CMT), and RS were evaluated by microperimetry (MAIA) within the 10 degree of the foveal center. To determine significant differences between the values, we used paired t tests.Patients were evaluated at baseline and 4 weeks after the third injection. The BCVA improved significantly from 0.18 ± 0.06 logarithm of the minimum angle of resolution (logMAR) units to 0.13 ± 0.13 logMAR units (P = .002; paired t test). The CMT decreased significantly from 464.3 ± 91.8 μm to 393.4 ± 129.0 μm (P = .005), and the RS also improved significantly from 21.8 ± 3.1 dB to 24.1 ± 2.8 dB at 4 weeks after treatment (P = .006). Among the patients with a decimal BCVA of 0.7 or better at baseline, there was no significant improvement in the BCVA (P = .28). However, the CMT decreased significantly from 479.5 ± 79.1 μm to 394.0 ± 99.8 μm at 4 weeks after treatment (P = .007). The RS also improved significantly from 22.0 ± 2.4 dB to 24.0 ± 3.1 dB at 4 weeks after treatment (P = .004).Measuring RS by microperimetry is a good option for evaluating the effectiveness of anti-VEGF treatment for DME patients with a relatively good BCVA.

Initial experience with novel CGRP-receptor inhibitor therapy in Migraine in the United Arab Emirates: a retrospective observational study

BackgroundErenumab is a calcitonin gene-related peptide (CGRP)-receptor antibody inhibiting CGRP function. CGRP is prominently involved in the pathophysiology of migraine through nociceptive modulation in the trigeminovascular system. This study aims to explore the treatment effect of erenumab in a real-life setting.MethodsIn this retrospective observational study, we analyzed the data of 91 patients with migraine receiving at least three consecutive monthly injections of erenumab and followed up for 3–12 months. The primary objective was to describe the reduction in monthly migraine days throughout the follow-up period. To identify patients who responded to treatment, we analyzed the association between different patient characteristics and their treatment outcomes.ResultsSeventy-three patients (80.2%) responded to erenumab treatment, defined as ≥50% reduction of migraine days per month, across all migraine types. It was noted that ethnicity (p-value = 0.015) and older age (p-value = 0.035) were associated with clinically relevant improvement of symptoms. Middle Eastern ethnicity was related to less improvement of symptoms while Europeans were more likely to benefit from erenumab therapy (odds ratio: 12.788, p = 0.037). Patients aged from 31 to 40 and 41–65 years benefited most from erenumab treatment with a response rate of 77.8 and 89.9%, respectively, also confirmed by logistic regression (p = 0.047). Neither gender nor dose increase of erenumab showed association with the reported clinically relevant improvement of the symptoms. An association between clinically relevant improvement of headaches and the type of migraine was also noted. Around 87.9% of patients with episodic migraine responded to treatment, followed by 84.1% of chronic migraine patients and 50% of medication overuse headache patients. Medication overuse headache showed a lower probability of therapy success with erenumab (odds ratio: 0.126, p = 0.039). An improvement of headaches was eminent in patients who received 140 mg erenumab monthly (2 × 70 mg injections) and patients who had one injection every two weeks.ConclusionsErenumab is a novel preventive treatment for all migraine types. Clinically relevant improvement of headaches and reduction of monthly migraine days were demonstrated in patients that continued the treatment course. In real-life, a substantial number of patients suspended therapy early, reasons for which need further investigation.

Optical Coherence Tomography Biomarkers Predicting Visual Acuity Change after Intravitreal Bevacizumab Injections for Macular Edema Secondary to Branch Retinal Vein Occlusion

Purpose: This study aimed to identify baseline optical coherence tomography (OCT) factors in branch retinal vein occlusion (BRVO) that predict response to bevacizumab injections. Methods: It is a retrospective case series of consecutive patients that underwent OCT at diagnosis, and the central macular thickness (CMT), extent of disorganized retinal inner layers, and outer retinal layers including external limiting membrane, ellipsoid zone (EZ), and cone outer segment tips (COST) were measured. Patients received 3 consecutive monthly injections of bevacizumab followed by pro re nata treatment. The main outcome measure was improvement in best-corrected visual acuity (BCVA) after 1 year. Results are expressed as mean ± SD, and p value <0.05 was considered statistically significant. Results: Overall, 66 eyes of 66 patients, with an average age of 68.5 ± 11.4 years, were included. The mean BCVA improved significantly from 0.68 logMAR at baseline to 0.50 logMAR at 1 year (p < 0.001). Baseline logMAR BCVA (r = 0.41, p < 0.001) and CMT (r = 0.23, p = 0.04) were associated with improvement while EZ (r = −0.24, p = 0.05) and COST (r = −0.32, p = 0.01) disruption with deterioration in BCVA. Conclusion: In patients with naïve BRVO treated with bevacizumab, BCVA improvement at 1 year can be predicted from baseline BCVA, CMT, extent of COST disruption, and EZ disruption.

Topical ketorolac as an adjunctive treatment with intravitreal bevacizumab in the management of diabetic macular edema: A double-masked placebo-controlled randomized clinical trial.

To evaluate the additional effect of ketorolac eye drops on therapeutic effects of intravitreal Bevacizumab in patients with diabetic macular edema (DME) METHODS: In a randomized clinical trial, 50 patients with center involved DME (macular thickness ≥ 300 microns accompanied by decreased VA (24 < BCVA ≤ 70 ETDRS letters) were enrolled consecutively and randomized 1:1 to receive either bevacizumab plus topical ketorolac (25 patients) or bevacizumab plus artificial tears (25 patients). Patients with proliferative diabetic retinopathy, history of intraocular surgery, intravitreal injection in less than three months, macular photocoagulation less than 6months and any other concomitant ocular pathologies were excluded from the study. All the patients received three consecutive monthly injections of intravitreal bevacizumab (IVB). After that, patients were examined every 6weeks and reinjection was administered based on the "as needed" protocol if macular thickness was 300 microns or more and VA was 70 ETDRS letters or less.. Patients also received either topical ketorolac or artificial tears three times a day over the study period (6months). Changes in central subfield thickness (CST), best-corrected visual acuity (BCVA, ETDRS letters), and number of IVB injections were compared between the study groups. Fifty eyes of 50 patients were included (25 eyes in each group). Mean CST was significantly decreased in both study groups at 14th week (-87 ± 98µm, P = 0.012 and -100 ± 147µm, P = 0.006 in bevacizumab plus ketorolac and bevacizumab plus artificial tears groups, respectively). Nevertheless, the changes of mean CST remained significant only in bevacizumab plus ketorolac group up to 26th week (-147 ± 124µm, P < 0.001 and -51 ± 145µm, P = 0.245, respectively). Comparing two groups, reduction of mean CST from baseline was significantly greater in bevacizumab plus ketorolac group compared with the control group at 26th week. (difference = -97µm, 95%CI = -182 to -11, P = 0.017). In the study group, mean BCVA significantly increased at both 20th week (6.2 ± 10.1, P = 0.04) and 26th week (8.2 ± 10.9, P = 0.03). In contrast, visual acuity did not significantly improve at any time points in bevacizumab plus artificial tears group, While insignificant, the 26-week mean change of visual acuity from baseline was greater in bevacizumab plus ketorolac group (difference = 6.5 ETDRS letter; 95%CI = -14.4 to 1.4) Two groups were comparable regarding number of IVB injections (P = 0.99). Topical ketorolac 0.5% three times a day could enhance and sustain the efficacy of intravitreal bevacizumab in the treatment of DME.

One-year Results of Aflibercept Treatment for Polypoidal Choroidal Vasculopathy with Good Visual Acuity.

PurposeTo evaluate the one-year efficacy of intravitreal aflibercept injection in polypoidal choroidal vasculopathy (PCV) with best-corrected visual acuity (BCVA) of 20 / 40 or better.MethodsThis was a multicenter retrospective study. The medical records of patients diagnosed with treatment-naïve PCV were retrospectively reviewed. Patients with an initial BCVA of 20 / 40 or better and who had undergone intravitreal aflibercept injection were included. Patients were treated with three consecutive monthly injections, followed by pro re nata regimen according to the clinician’s discretion at variable interval visits. The proportions of eyes for which BCVA was maintained (≤ 0.2 logarithm of the minimum angle of resolution change) or improved at 12 months were evaluated. The changes of BCVA, central subfield macular thickness (CSMT), pigment epithelial detachment, and subretinal fluid also were assessed.ResultsA total of 86 eyes were included. The mean number of injections for 12 months of treatment was 5.4 ± 1.7. BCVA was maintained or improved in 94.2% (81 / 86) of cases. Mean BCVA (logarithm of the minimum angle of resolution) had changed from the baseline (0.23 ± 0.09) at 3 months (0.21 ± 0.14), 6 months (0.24 ± 0.22), and 12 months (0.20 ± 0.18), but with no statistical significance. CSMT had improved significantly from the baseline (336.1 ± 97.3 μm) at 3 months (223.6 ± 47.22 μm), 6 months (239.6 ± 64.2 μm), and 12 months (223.8 ± 47.9 μm). Pigment epithelial detachment was observed in 93% of cases at the baseline, 72.1% at 3 months, and 69.8% at 12 months, showing a significant decrease at all observation points. Subretinal fluid was observed in 91.9% of cases at the baseline, 20.9% at 3 months, and 29.1% at 12 months, showing a significant decrease at all observation points.ConclusionsIn cases of PCV with good visual acuity, intravitreal aflibercept injections decreased CSMT and were effective in maintaining visual acuity.

Comparison of Intravitreal Bevacizumab versus Intravitreal Ranibizumab in Treatment Naive Macular Edema Patients (Real World Evidence in Pakistan)

Purpose: To compare the short-term efficacy and safety of intraocular Ranibizumab and Bevacizumab in patients with treatment Naïve macular edema.&#x0D; Study Design: Quasi experimental study.&#x0D; Place and Duration of Study: Amanat Eye Hospital, from August 2018 to November 2019.&#x0D; Methods: Patients with macular edema confirmed with optical coherence tomography (OCT) or leakage on fluorescein angiography were included. Patients with NVE, PDR without macular edema and patients who switched to alternative anti-VEGF compounds prior to the completion of three consecutive monthly injections of their respective anti-VEGF or switched to other treatment options were excluded from the study. A thorough clinical examination was conducted including best corrected visual acuity (BCVA, intraocular pressure (IOP), anterior and posterior segment examination and OCT macula. The patients were then allocated to one of the two study arms (either Bevacizumab or Ranibizumab) based on the doctor’s input and patient affordability. All patients underwent three consecutive injections of the selected molecule at one month intervals. BCVA, CRT and macular volume were then recorded 04 weeks after the third injection.&#x0D; Results: A statistically significant mean vision gain was observed from baseline in both groups (p &lt; 0.05). However, the change in BCVA was not significantly different between intravitreal Bevacizumab group and intravitreal Ranibizumab group (p &gt; 0.05). Similarly, although there was improvement in CRT and macular volume in both groups but there was no statistically significant difference between the two.&#x0D; Conclusions: Treatment with intravitreal Bevacizumab and Ranibizumab injections cause statistically similar anatomical and functional results in cases of treatment naïve macular edema.&#x0D; Key Words: Bevacizumab, Ranibizumab, Macular Edema, Diabetic Retinopathy, Macular Degeneration, Retinal Vein Occlusion.

Multifocal Electroretinogram Alterations after Intravitreal Ranibizumab Treatment in Diabetic Macular Edema.

Objectives:To assess multifocal electroretinogram (mf-ERG) values in patients with diabetic macular edema (DME) who were treated with intravitreal ranibizumab (IVR).Methods:Thirty eyes of patients with DME, who underwent three consecutive monthly injections of IVR and as required thereafter, were evaluated. Best corrected visual acuity (BCVA) (log MAR), optical coherence tomography (OCT) features [diameters of cyst and subretinal fluid, hyperreflective dots (HRDs)], and mf-ERG were evaluated at baseline, 1 month, and 6 months throughout the follow-up period. The correlation of mf-ERG values and OCT features, BCVA, and the duration of disease were investigated.Results:In the study group, the baseline P1 and N1 amplitudes were significantly lower than the control group, and P1 and N1 implicit times were significantly higher in patients with DME than in the control group in all rings (All p<0.05) The mean response density (P1 amplitude, nV/deg2) values increased over 6 months in rings 1, 2, and 3 (p<0.001, p=0.003, p=0.006). There was a negative correlation between the diameter of the cyst and the initial response density of P1 (for horizontal diameter: r=–0.658, p=0.03; for vertical diameter: r=–0.597, p=0.037; for the area of the cyst, r=–0.603, p=0.021). There was a significant negative correlation between the subretinal fluid and HRD reduction and the response density of P1 increase (all p<0.05). At baseline and 6 months, the correlation between BCVA and the P1 and N1 amplitude of the central ring was significant (for baseline P1: r=–0.649, p=0.01; for N1: r=–0.575, p=0.02; for 6-month P1, r=–0.603, p<0.001; for N1: r=–0.591, p=0.005).Conclusion:The combination of OCT and mf-ERG can be used to evaluate the functional recovery in DME.

Angiogenin, FGF-\u03b1, and IL-36\u03b2 have higher expression levels in aqueous humor of nAMD patients in comparison to cataract patients

BackgroundNumerous cytokines have been proven to participate in the pathogenesis of neovascular age-related macular degeneration (nAMD). The present study aimed to investigate the aqueous humor cytokine expression profile in nAMD patients before and after ranibizumab treatments in comparison to cataract patients.MethodsThis prospective study included 20 treatment-naïve nAMD eyes of 20 patients who received three consecutive monthly injections of ranibizumab. Aqueous humor samples were collected before the first (baseline), second (1 month later), and third (2 months later) injections. Controls were 20 age- and gender-matched cataract patients without any other ocular disease. The aqueous concentrations of 28 cytokines were measured using a multiplex bead assay. Central macular thickness (CMT) and maximum retinal thickness (MRT)-3 mm were measured by spectral domain optical coherence tomography (SD-OCT). The greatest linear diameter (GLD) was measured by fundus fluorescein angiography (FA).ResultsThree cytokines in aqueous humor, including angiogenin, interleukin-36β (IL-36β), and fibroblast growth factor-acidic (FGF-α) were significantly higher in nAMD patients in comparison to cataract patients, both before and after two consecutive monthly ranibizumab injections. Compared with the nAMD patients’ basal levels, two consecutive monthly ranibizumab injections effectively reduced the aqueous concentrations of VEGF-A and placental growth factor (PlGF), as well as the values of CMT, MRT-3 mm, and GLD.ConclusionsAngiogenin, IL-36β, and FGF-α have higher expression levels in nAMD patients in comparison to cataract patients, both before and after 2 months of ranibizumab therapy. These cytokines may have correlations with the pathogenesis of nAMD.

Predicting response of ischemic central retinal vein occlusion to bevacizumab injections: 1year follow-up.

To identify baseline optical coherence tomography (OCT) factors in ischemic central retinal vein occlusion (CRVO) that predict response to bevacizumab injections. Patients underwent OCT at diagnosis and the central macular thickness, subretinal fluid width and height as well as the presence of intraretinal cysts were measured. The extent of disorganized retinal inner layers, outer plexiform layer (OPL), external limiting membrane, ellipsoid zone and cone outer segment tips (COST) was recorded. Patients received three consecutive monthly injections of bevacizumab followed by pro re nata treatment. Overall 32 eyes of 32 patients aging 69.4 ± 12.7years were included. In univariate correlational analyses baseline OPL disruption (- 41, p = 0.02), EZ disruption (r = - 0.36, p = 0.05) and COST disruption (r = - 0.37, p = 0.04) correlated with deterioration in BCVA at 1year. Partial least squares demonstrated that the factors most largely associated with deterioration in BCVA were COST disruption and OPL disruption followed by EZ disruption, while worst vision at baseline was associated with improvement in vision. In patients with ischemic CRVO treated with bevacizumab, BCVA improvement at 1year can be partially predicted from baseline OCT measurements by the extent of COST, OPL and EZ disruption.

PERIPHERAL ISCHEMIC RETINAL PHOTOCOAGULATION IN ADDITION TO INTRAVITREAL BEVACIZUMAB VERSUS INTRAVITREAL BEVACIZUMAB ALONE FOR THE TREATMENT OF MACULAR EDEMA SECONDARY TO CENTRAL RETINAL VEIN OCCLUSION: A Randomized Double-Masked Controlled Clinical Trial.

To investigate the effects of peripheral ischemic retinal photocoagulation in addition to intravitreal bevacizumab (IVB) in the treatment of macular edema due to ischemic central retinal vein occlusion. Forty-eight eyes of 48 treatment-naive patients were randomly selected and divided into 2 groups. Group A comprised 24 eyes that were treated with three consecutive monthly injections of IVB, and Group B comprised 24 eyes that were treated with IVB plus photocoagulation of the peripheral nonperfused retina. Further IVB injections were administered as needed in both groups. Monthly follow-up was conducted for 9 months after the first injection. The data of 46 patients were analyzed. Best-corrected visual acuity changes from the fourth to eighth month follow-up in comparison with the baseline were significantly higher in Group B (P = 0.002-0.044-0.002-0.002-0.012). In addition, significant differences were observed in central macular thickness in Group B throughout the study period (all P < 0.001). Group B required less frequent IVB injections during the 9-month study period. Photocoagulation of the retinal nonperfused area in patients with macular edema because of central retinal vein occlusion might amplify the beneficial effects of IVB on best-corrected visual acuity and central macular thickness and reduce the frequency of IVB injection.

Intravitreal ranibizumab and dexamethasone implant injections as primary treatment of diabetic macular edema: simultaneously double protocol

PurposeTo assess the 12-month efficacy and safety of simultaneously administered intravitreal dexamethasone implant (DEX implant) and ranibizumab (simultaneous double protocol) injections in comparison with ranibizumab monotherapy as the first-line treatment of diabetic macular oedema (DMO).MethodsProspective, consecutive, clinical interventional study. Patients were randomized into two groups: 24 naive DMO patients (34 eyes) who received simultaneous double-protocol therapy and 22 DMO patients (34 eyes) who received ranibizumab monotherapy were included. Monthly ranibizumab (0.5 mg) was administered for the first 6 months and later on, an as-needed treatment basis. DEX implant injection was performed at any time during the loading dose of the three consecutive monthly injections of ranibizumab, and with as-needed reinjections of ranibizumab from 6th month onwards. Change in visual acuity was the primary efficacy endpoint. Secondary efficacy endpoints were a gain of ≥15 letters and a change in the central foveal thickness.ResultsMean BCVA increased from baseline to month 12 in the simultaneously double-protocol therapy group compared with the ranibizumab monotherapy group (21.6 versus 9.6 letters [P < 0.001]). The corresponding proportions of eyes gaining ≥15 letters were 60% versus 29.4% (P < 0.0001). Moreover, the mean reductions in the central foveal thickness were 413 versus 282 µm (P = 0.001). At 12 month, the simultaneous double-protocol therapy decreased a significant number of foveal cysts and subfoveal neuroretinal detachment compared with those by ranibizumab monotherapy.ConclusionsThe simultaneous addition of DEX implant at any time during the three monthly loading doses of ranibizumab in patients with DMO significantly improved the visual outcomes and revealed superior anatomic outcomes than those with the ranibizumab monotherapy.