Mean Visual Acuity Gain Research Articles

SEQUENTIAL PARS PLANA VITRECTOMY AND INVERTED INTERNAL LIMITING MEMBRANE FLAP TECHNIQUE FOR RHEGMATOGENOUS RETINAL DETACHMENTS WITH PERIPHERAL BREAKS AND CONCOMITANT NONCAUSATIVE MACULAR HOLE IN NONHIGHLY MYOPIC PATIENTS.

To present the anatomical and functional results of sequential pars plana vitrectomy for treating rhegmatogenous retinal detachment with peripheral breaks and concomitant noncausative macular holes (MHs) in nonhighly myopic patients. Medical records of patients who underwent rhegmatogenous retinal detachment surgical repair between 2017 and 2023 were reviewed. Of 980 patients with rhegmatogenous retinal detachment, 10 had concurrent MH and underwent sequential pars plana vitrectomy for rhegmatogenous retinal detachment repair and air endotamponade, followed by MH repair using the inverted internal limiting membrane flap technique and C2F6 endotamponade after a minimum of 1 week. The main outcomes measured were best-corrected visual acuity change, retinal reattachment rate, MH closure rate, and closure type. The retinal reattachment rate was 90% after the primary surgery and 100% after subsequent surgery. Macular hole closure was achieved in all cases. Macular hole diameters ranged from 291 to 702 µm. Anatomical recovery showed mainly 1A closure types (90%). Functional recovery demonstrated significant best-corrected visual acuity improvement, with a mean visual acuity gain of 1.58 ± 0.41 the logarithm of the minimum angle of resolution. For this infrequent pathology, sequential surgery using the inverted internal limiting membrane flap technique and air/gas endotamponade yielded favorable anatomical and functional outcomes. This controlled and standardized approach using sequential surgeries contributes to the achievement of consistent results.

Treatment Outcomes of Intravitreal Aflibercept for Uveitic Macular Edema.

To evaluate the efficacy of intravitreal aflibercept for UME (uveitic macular). A retrospective review of records of patients that received aflibercept for UME from January 2017 to August 2022 was conducted. The primary outcomes were mean change in visual acuity (VA) and central subfield thickness (CST) 6 and 12 months from the start of aflibercept treatment. A total of 16 eyes of 12 patients were included. Indications for treatment included eyes that had previously demonstrated a history of elevated intraocular pressure secondary to a steroid response (n = 10) or a history of non-response or partial response to local corticosteroids (n = 6). Fifteen eyes (94%) demonstrated a reduction in CST after their initial injection. At 6-months, mean VA gain was 2.6 ± 7.7 letters (p = 0.24) from a mean VA of 67.8 ± 10.7 letters at baseline and mean CST improved by 97.6 ± 113.5 μm (p = 0.004) from 458.6 ± 123.1 μm at baseline. Fourteen eyes had 12-months of follow up and received a median of 4 injections over 12 visits. The mean VA at 12-months remained stable compared to baseline (mean change of -1.4 ± 12.5 letters (p = 0.87)) while the CST improved by a mean of 90.9 ± 114.6 μm (p = 0.053) compared to baseline. Intravitreal aflibercept injections resulted in reduced central subfield thickness at all time-points. It appears to be an effective treatment alternative for UME, particularly for patients who are not responsive to local corticosteroids or who have contraindications to corticosteroid treatment.

Real-world outcomes of intravitreal bevacizumab treat-and-extend for cystoid macular oedema secondary to central retinal vein occlusion.

The purpose of this study was to report the real-world treatment outcomes using a treat-and-extend intravitreal bevacizumab protocol in cystoid macular oedema (CMO) secondary to central retinal vein occlusion (CRVO). We conducted a retrospective case series of consecutive adult patients with CMO secondary to CRVO who presented between 1st January 2019 and 31st December 2021. All included patients were treated with bevacizumab using a treat-and-extend protocol, were followed up for a minimum of 6months and had a clinical examination including best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) at every visit. The primary outcome measure was mean change in BCVA. Thirty-three eyes of 33 patients were included in the study. The mean change in BCVA from baseline was + 24.5 (Median 18, SD 21.5) letters, with a mean follow-up duration of 18.5 (SD 8.9) months. The mean number of injections was 9.5 (SD 1.9) in year 1 and 7.8 (SD 2.8) in year 2. 87.9% of patients were still requiring active treatment, with a maximum interval achieved of 4-weekly in 18.2%, 6-weekly in 42.4%, 8-weekly in 6.1%, 10-weekly in 15.2%, and 12-weekly in 6.1%. The mean maximum interval achieved of those requiring ongoing treatment was 6.8 (SD 2.4) weeks. Multiple regression analyses showed that a higher baseline BCVA was negatively associated with mean visual acuity gain (P < 0.001) and positively associated with final BCVA (P < 0.001). The use of intravitreal bevacizumab in a treat-and-extend regimen is effective in treating CMO secondary to CRVO, in a real-world setting.

Anti-vascular endothelial growth factor dosing frequency and visual outcomes in macular oedema following branch retinal vein occlusion

ObjectivesTo determine the relationship between treatment frequency with intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents and visual acuity (VA) outcomes in eyes with macular oedema (MO) secondary to branch retinal vein occlusion (BRVO) in US clinical practice.MethodsStudy eyes that initiated anti-VEGF injections between January 2012 and May 2016 were followed for ≥1 year in a retrospective analysis of medical records (Vestrum Health database). Eyes were analysed in 2 cohorts by treatment duration (years 1 and 2) and then in 2 subcohorts by injection frequency (≤6 or ≥7 injections/year).ResultsAmong 3099 eyes with MO secondary to BRVO, 1197 (38.6%) received ≤6 injections (mean injections, 4.6; baseline mean VA, 53 letters) and 1902 (61.4%) received ≥7 injections through 1 year (mean injections, 8.8; baseline mean VA, 52 letters). At year 1, mean VA gain from baseline was 10.4 versus 13.9 letters in eyes receiving ≤6 versus ≥7 injections (p < 0.001). At year 2, mean VA in eyes receiving ≤6 (n = 42) versus ≥7 injections (n = 227) was 64 versus 68 letters, respectively (p = 0.19). Mean VA change between the start and end of year 2 in eyes receiving ≥7 injections in year 1 and ≤6 in year 2 differed significantly from that of eyes receiving ≥7 injections in both years (–3.0 vs 0.7 letters, respectively; p < 0.001).ConclusionsIn routine clinical practice, more frequent dosing with anti-VEGF agents was associated with greater visual benefits in eyes with MO secondary to BRVO.

Artificial intelligence-based fluid quantification and associated visual outcomes in a real-world, multicentre neovascular age-related macular degeneration national database

AimTo explore associations between artificial intelligence (AI)-based fluid compartment quantifications and 12 months visual outcomes in OCT images from a real-world, multicentre, national cohort of naïve neovascular age-related macular degeneration...

Anatomical and functional results of vitrectomy and gas tamponade in macular hole treatment

AbstractBackground: Idiopathic macular holes (IMH) of large sizes are still challenging for vitreoretinal surgeons. Predict factors of the treatment effectiveness are little‐known.Purpose: To evaluate the effectiveness of large idiopathic macular holes surgery with 18% perfluoropropane (C3F8) gas tamponade.Methods: The retrospective study, which includes 68 eyes of 68 patients diagnosed with IMH stage 3 or stage 4 (Gass classification) between January 2015 and January 2020. Among them, there were 16 men (23.5%) and 52 women (76.5%). The mean age of patients was 66.7 ± 4.3. Morphologic parameters of the macular hole (base diameter, minimum diameter) were measured and then hole form factor (HFF) was calculated. All eyes underwent 25 gauge pars plana vitrectomy, internal limiting membrane peeling, 18% C3F8 gas tamponade and postoperative face‐down positioning for two weeks. The minimum follow‐up period was 3 months and the mean follow‐up period was 19.6 ± 11.4 months. The main outcome measures were IMH closure confirmed by spectral domain optical coherence tomography at 1 month postoperatively and visual acuity at 3 months postoperatively.Results: No intra‐ and postoperative complications were observed. The IMH were closed in 61 out of 68 eyes at one month after surgery. The anatomic closure rate was 89.7%. The mean base diameter of IMH was 1022.82 ± 292.36 μm (range: 682–2019 μm). The mean minimum diameter of IMH was 471.71 ± 138.73 (range: 258–766 μm). The mean preoperative BCDVA was 0.72 ± 0.29 logMAR and mean postoperative BCDVA at 3 months after surgery was 0.5 ± 0.33 logMAR (p = 0.063, t‐test). In 47 patients (69.1%) BCDVA improved after surgery. Mean gain in visual acuity at 3 months after operation was 0.20 ± 0.27 (ΔBCDVA, logMAR). Visual acuity worsened or remained unchanged after surgery in 21 patients (30.9%) due to postoperative vitreoretinal interface disorders (foveal thinning, retinal pigment epithelium defects, and foveal cysts). The mean HFF value was 0.77 ± 0.09. There was a statistically significant moderate positive correlation between HFF and postoperative BCDVA (r = 0.56, p = 0.03, Spearman's Rho).Conclusion: Macular hole surgery with 18% C3F8 tamponade is effective technique and is associated with high rates of IMH closure and postoperative BCVA improvement. HFF was significantly correlated with postoperative visual outcomes in cases of large IMH.

OCT angiography biomarkers in type 1 choroidal neovascularisation after one year of aflibercept treatment

ObjectiveTo assess the activity of biomarkers, through OCT angiography (OCTA), of choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) treated with aflibercept. As secondary endpoints, visual acuity (VA) and the relationship between biomarkers and visual prognosis were also studied. Material and methodsProspective study that examined 33 eyes of 40 naïve patients with type 1 CNV secondary to AMD, who had been treated with aflibercept, according to summary of product characteristics, for one year. The patients were evaluated at the time of diagnosis, and at 4, 8 and 12 months. ResultsThe mean VA gain at 12 months was 15.2 ± 3.3 letters. The area of lesion decreased 1.2 ± 1.0 mm2 in the 4th month (P < .0001), remaining stable afterwards. The presence of tiny capillaries, anastomosis and perilesional hypointense halo was reduced by 85%, 70% and 25%, respectively, at 12 months of follow-up. The peripheral vascular arcade changed morphology, from having a leafy appearance to having a sharp appearance in 90% of cases. The size of the lesion and the presence/absence of perilesional hypointense halo were independently associated with the final VA, in such a way that larger lesions and the absence of a perilesional hypointense halo at the baseline visit were associated with less VA gain. ConclusionsThe OCTA is a useful, non-invasive tool that provides quantitative and qualitative information on the remodelling of the CNV vascular network after antiangiogenic therapy.

Biomarcadores de OCT-angiografía en la neovascularización coroidea tipo 1 tras tratamiento con aflibercept durante 1 año

ObjectiveTo assess the activity of biomarkers, through OCT angiography (OCTA), of choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) treated with aflibercept. As secondary endpoints, visual acuity (VA) and the relationship between biomarkers and visual prognosis were also studied. Material and methodsProspective study that examined 33 eyes of 40 naïve patients with type1 CNV secondary to AMD, who had been treated with aflibercept, according to summary of product characteristics, for one year. The patients were evaluated at the time of diagnosis, and at 4, 8 and 12months. ResultsThe mean VA gain at 12months was 15.2±3.3 letters. The area of lesion decreased 1.2±1.0mm2 in the 4th month (P<.0001), remaining stable afterwards. The presence of tiny capillaries, anastomosis and perilesional hypointense halo was reduced by 85%, 70% and 25%, respectively, at 12months of follow-up. The peripheral vascular arcade changed morphology, from having a leafy appearance to having a sharp appearance in 90% of cases. The size of the lesion and the presence/absence of perilesional hypointense halo were independently associated with the final VA, in such a way that larger lesions and the absence of a perilesional hypointense halo at the baseline visit were associated with less VA gain. ConclusionsThe OCTA is a useful, non-invasive tool that provides quantitative and qualitative information on the remodelling of the CNV vascular network after antiangiogenic therapy.

Étude rétrospective de vraie vie de patients traités par injections intra-vitréennes de dexaméthasone ou d’anti-VEGF pour œdèmes maculaires diabétiques ou secondaires à une occlusion veineuse rétinienne : à propos de 98 yeux

To evaluate long term outcomes of patients presenting with diabetic macular edema (DME) or edema secondary to a retinal vein occlusion (RVO). This is a real world, retrospective, single-center study of 65 eyes of 47 patients treated for DME and 33 eyes of 33 patients with macular edema secondary to RVO between July 2012 and October 2018. The patients treated were treatment-naive and were followed for at least one year. We collected data such as visual acuity, central macular thickness, intravitreal injections (number/year, injection schedule, number of switches), number of visits and cases of vision loss. DME: the mean age at inclusion was 65.9years with 60.4% women, and the mean follow-up was 28.5months. The mean gain in visual acuity after 1year of follow-up was 6.4 ETDRS letters for patients treated with anti-VEGF and 2.6 letters for patients treated with dexamethasone. The average number of intravitreal injections of anti-VEGF was 5.6/year, compared to 2.9/year for dexamethasone. Fourteen patients initially treated with anti-VEGF were switched to dexamethasone. RVO: the mean age at inclusion was 68.8years with 54.5% women and a mean follow-up of 31.1months. The mean gain in visual acuity after 1year of follow-up was 26.7 ETDRS letters for patients treated with anti-VEGF and 7.0 letters for patients treated with dexamethasone. The average number of intravitreal injections of anti-VEGF was 5.8/year, compared to 2.4/year for dexamethasone. Five patients initially treated with anti-VEGF were switched to dexamethasone in the first year of follow-up. In this real-life retrospective study, we found good anatomical and functional results similar to those reported in other studies, remaining stable over time, for patients with DME or macular edema secondary to RVO.

An observational clinical study of the influence of phacoemulsification on choroidal neovascular membrane activity in age related macular degeneration

BackgroundThousands of phacoemulsification surgeries are performed on eyes with age-related macular degeneration (AMD) complicated by choroidal neovascular membrane (CNV) in the United Kingdom each year. As populations age this number is expected to rise. Controversy over phacoemulsification’s influence on CNV activity limits the information which clinicians and these patients use to decide on surgery. This observational study aims to resolve this controversy by reporting on intravitreal injection (IVI) frequency as a pragmatic marker of CNV activity in a large cohort.MethodsA cohort of eyes with AMD complicated by CNV (n = 327) that underwent cataract surgery at a single tertiary centre from 2014 to 2019 were identified. These cases were matched by interval since CNV diagnosis at a specified ‘time zero’ within the follow-up of pseudophakic eyes with AMD (n = 327). Data concerning demographics, visual acuity (VA) and intravitreal injection frequency before and after ‘time zero’/phacoemulsification were collected.ResultsFollowing ‘time zero’/phacoemulsification’ the mean reduction in annual IVI frequency was 0.6 injections/year (95% CI 0.4,0.9) and 0.4 injections/year (95% CI 0.1,0.7) in the comparison and phacoemulsification cohorts respectively. The mean VA gain 12 months after phacoemulsification in the intervention cohort was 11.3 (95% CI 9.2,13.4) early treatment of diabetic retinopathy study (ETDRS) letters, with 214 eyes (65.4%) having gained ≥5 ETDRS letters after surgery.ConclusionsPhacoemulsification has no clinically significant impact on the activity of pre-existent CNV secondary to AMD. Phacoemulsification should be offered to patients with AMD and cataract that limits vision, regardless of CNV activity.

Visual outcomes and associated factors of primary congenital glaucoma in children.

We evaluated the long-term visual outcomes in children with primary congenital glaucoma and determined the factors associated with the final visual outcomes. Medical records of children with primary congenital glaucoma between 2005 and 2016, seen at Seoul National University Children's Hospital in South Korea, were reviewed. The minimum follow-up period after surgery for primary congenital glaucoma was 3years. Visual acuity (VA) was categorized into good (≧20/70) and poor (< 20/70). Factors including age, VA, refractive errors, intraocular pressure (IOP), laterality, and cup-to-disc (C/D) ratio were compared between the groups. A total of 71 eyes of 44 patients were included. The patients' age at the time of surgery was 14.7 ± 12.2months. The mean IOP was 28.3 ± 7.0mmHg. During 6.7 ± 2.7years of mean follow-up after surgery, 39 eyes (54.9%) needed occlusion treatment. After occlusion, patients with lower IOP values, lesser additional surgeries, reversal of optic disc cupping, and better initially measured VA achieved a better visual outcome. At the final assessment, the mean age was 7.8 ± 2.6years, and the mean VA gain was 15.0 ± 19.4 letters. There were 44 eyes (62.0%) with VA ≧20/70. In children with primary congenital glaucoma, IOP control and the optic disc configuration over time are important factors associated with visual outcome. Regular follow-up and correction of refractive errors-along with occlusion for those with difference in VA between the two eyes-might be helpful for achieving better visual outcomes.

Visual Acuity Outcomes in Patients Receiving Frequent Treatment of Neovascular Age-Related Macular Degeneration in Clinical Practice.

This work evaluates dosing frequency with intravitreal antivascular endothelial growth factor (anti-VEGF) agents over 2 years and visual acuity (VA) outcomes in neovascular age-related macular degeneration (nAMD). This retrospective analysis assesses electronic medical record data (Vestrum Health treatment and outcomes database) of newly diagnosed nAMD in patients who were initiated on intravitreal anti-VEGF treatment at US clinical sites. Eyes were divided into 2 injection frequency subcohorts (≤ 6 or > 6 injections/y); treatment frequency and change in mean VA (Early Treatment Diabetic Retinopathy Study letters) were evaluated. Overall, 8127 of 213 824 eyes met inclusion criteria in year 1 and 4968 in year 2. During year 1, 77% of the eyes received more than 6 injections (n = 6287), the majority of which received injections at the same frequency during year 2. Mean VA gain from baseline at year 1 was lower in the ≤ 6 than > 6 injections/y subcohort (2.2 vs 6.5, P < .001). Decrease in mean VA from the end of year 1 to year 2 was significantly greater for eyes administered 6 or fewer injections in year 2 than those that received more frequent injections, irrespective of the frequency of injections in the first year. In routine clinical practice, most eyes with nAMD that completed at least 1 year of follow-up were treated with more than 6 injections of anti-VEGF agents during the first year of treatment, resulting in better VA gains than eyes treated less frequently during the same period.

Evaluation of Patients Receiving Intravitreal Antivascular Endothelial Growth Factor for Diabetic Macular Edema in Clinical Practice in the United States.

We assessed the effect of treatment frequency with intravitreal antivascular endothelial growth factor (anti-VEGF) agents on visual acuity (VA) in diabetic macular edema (DME). This retrospective analysis assessed electronic medical records of eyes newly diagnosed with DME and treated with an anti-VEGF agent at US clinics using the Vestrum Health (Naperville, Illinois) treatment and outcomes database. Eyes were divided into 2 injection frequency subcohorts (≤ 6 vs > 6 injections/y); treatment frequency and change in mean VA (Early Treatment Diabetic Retinopathy Study letters) were evaluated. Among 155 240 eyes assessed, 3028 met inclusion criteria for analysis in year 1 and 1292 in year 2. During year 1 of treatment, 57% (n = 1725) received > 6 injections; most continued to receive the same injection frequency during year 2. Mean VA gain from baseline at year 1 was lower in the ≤ 6 than in the > 6 injections/year subcohort (3.7 vs 8.0 letters, respectively; P < .001). Mean VA change from the end of year 1 to year 2 for eyes receiving ≤ 6 injections in year 1 generally remained unchanged, irrespective of year 2 dosing frequency. In eyes that received > 6 injections in year 1, mean VA loss was significantly greater for eyes receiving less-frequent dosing in year 2 than in those maintained on > 6 injections. More than 50% of eyes with DME in routine clinical practice that completed at least 1 year of follow-up received > 6 injections of an anti-VEGF agent during the first year, resulting in better VA gains than eyes treated less frequently.

Twelve-month outcomes of intra-vitreal anti-VEGF agents for treatment-naïve neovascular age-related macular degeneration eyes: French data from the fight for retinal blindness!

To describe the one-year functional outcomes of treatment-naïve neovascular age-related macular degeneration (nAMD) treated with anti-VEGF agents at the Dijon University Hospital Ophthalmology Department. Real-life interventional study including all treatment-naïve nAMD patients from January 2016 to December 2018 in the Ophthalmology Department of Dijon University Hospital. Data were retrospectively collected from the Fight Retinal Blindness! (FRB!) registry. At baseline, medical history, visual acuity (VA), type of lesion and activity on angiography and optical coherence tomography (OCT), and treatment were recorded. On follow-up, VA, lesion activity and treatment were recorded. Three-hundred twenty eyes of 259 patients were included, of which 65.6% were female and with a mean age of 80.1±11.1 years. Mean VA (standard deviation, SD) at baseline was 53.2 ETDRS letters (25.3). All patients received anti-VEGF injections, of which 164 eyes (51.2%), 152 eyes (47.5%) and 4 eyes (1.2%) were treated with aflibercept, ranibizumab and bevacizumab, respectively. A total of 198 eyes of 169 patients completed the 12-month follow-up, with a median (first quartile, third quartile) of 12 visits (10, 13). At one year (n=198), the overall mean VA gain [95% CI] was +3.3 ETDRS letters [0.7, 5.9] and 173 (87.4%) of the treated eyes did not lose 15 or more letters. We found no statistically significant difference in mean VA gain between aflibercept and ranibizumab. This real-world study confirmed the efficacy of anti-VEGF agents in nAMD and the feasibility of analyzing data in an international registry.

Compliance and Visual Outcome Of “Treat-And-Extend” Versus “Pro Re Nata”Dosing of Intravitreal Bevacizumab in Wet Age-Related Macular Degeneration – A Perspective From a Developing Country

Introduction: Age- related Macular Degeneration (AMD) is the commonest cause of irreversible blindness and visual impairment in elderly, aged50 years or older contributing 8.7% of global blindness. Among the two types: “dry” and “wet”, the “wet” variant is treated using anti-VEGFs, mainly via two regimen – PRN or TREX.&#x0D; Objective: To study and compare the compliance, cost and visual outcome of “Treat-and- Extend (TREX)”versus “Pro Re Nata(PRN)” dosing of intravitrealbevacizumab in Wet AMD.&#x0D; Methodology: Sixty-four eyes of 64 patients with treatment naïve neovascular AMD were included and randomly divided into two groups, with each group comprising 32 eyes, by lottery system: “Group A [TREX]” and “Group B [PRN]”. Group A was treated with intravitrealbevacizumab [1.25mg/0.05ml] at presentation and at 1-month interval for 3 consecutive months [loading dose] and monthly till dry macula was obtained. Group B was treated with the same in “as needed” basis.Both Groups were followed up, for 1 year.&#x0D; Results Mean gain in visual acuity in the PRN group was 0.09 +/- 0.35 log MAR unit and in TREX, it was 0.14 +/- 0.3 log MAR unit within the period of 1 year.64% of the patients were compliant in TREX and 36% moderately complaint whereas in the PRN group, 24% were compliant, 60% moderately compliant and 16% noncompliant. Average hospital cost in PRN and TREX was NRs. 16, 170 (USD 149) and 23,785(USD 220) respectively.&#x0D; Conclusion: Compliance and visual outcome were better in TREX in comparison toPRN at 1 year of treatment with intravitrealbevacizumab for Wet AMD.

Ranibizumab and Bevacizumab for Treatment of Neovascular Age-related Macular Degeneration: Two-Year Results

To describe effects of ranibizumab and bevacizumab when administered monthly or as needed for 2 years and to describe the impact of switching to as-needed treatment after 1 year of monthly treatment. Multicenter, randomized clinical trial. Patients (n= 1107) who were followed up during year 2 among 1185 patients with neovascular age-related macular degeneration who were enrolled in the clinical trial. At enrollment, patients were assigned to 4 treatment groups defined by drug (ranibizumab or bevacizumab) and dosing regimen (monthly or as needed). At 1 year, patients initially assigned to monthly treatment were reassigned randomly to monthly or as-needed treatment, without changing the drug assignment. Mean change in visual acuity. Among patients following the same regimen for 2 years, mean gain in visual acuity was similar for both drugs (bevacizumab-ranibizumab difference,-1.4 letters; 95% confidence interval [CI],-3.7 to 0.8; P= 0.21). Mean gain was greater for monthly than for as-needed treatment (difference,-2.4 letters; 95% CI,-4.8 to-0.1; P= 0.046). The proportion without fluid ranged from 13.9% in the bevacizumab-as-needed group to 45.5% in the ranibizumab monthly group (drug, P= 0.0003; regimen, P < 0.0001). Switching from monthly to as-needed treatment resulted in greater mean decrease in vision during year 2 (-2.2 letters; P= 0.03) and a lower proportion without fluid (-19%; P < 0.0001). Rates of death and arteriothrombotic events were similar for both drugs (P > 0.60). The proportion of patients with 1 or more systemic serious adverse events was higher with bevacizumab than ranibizumab (39.9% vs. 31.7%; adjusted risk ratio, 1.30; 95% CI, 1.07-1.57; P= 0.009). Most of the excess events have not been associated previously with systemic therapy targeting vascular endothelial growth factor (VEGF). Ranibizumab and bevacizumab had similar effects on visual acuity over a 2-year period. Treatment as needed resulted in less gain in visual acuity, whether instituted at enrollment or after 1 year of monthly treatment. There were no differences between drugs in rates of death or arteriothrombotic events. The interpretation of the persistence of higher rates of serious adverse events with bevacizumab is uncertain because of the lack of specificity to conditions associated with inhibition of VEGF. Proprietary or commercial disclosure may be found after the references.

CLINICAL OUTCOMES OF DIFFERENT SUBTYPES OF NEOVASCULAR AGE-RELATED MACULAR DEGENERATION DURING AFLIBERCEPT TREATMENT.

To prospectively evaluate the outcomes of different subtypes of neovascular age-related macular degeneration during intravitreal aflibercept monotherapy. Forty-four eyes of 44 patients with treatment-naïve polypoidal choroidal vasculopathy (PCV, n = 12), hemorrhagic choroidal neovascularization (hCNV, n = 12), pigment epithelium detachment (PED, n = 11), or retinal angiomatous proliferation (RAP, n = 9) were included and followed for 12 months. All patients received intravitreal aflibercept monotherapy. Mean visual acuity at baseline in PCV was 67 ± 16 Early Treatment Diabetic Retinopathy Study letters (20/50 Snellen equivalent), in hCNV 55 ± 21 (20/80), in RAP lesions 64 ± 11 (20/50), and in PED 74 ± 7 (20/32). At Month 12, visual acuity in PCV was 66 ± 16 (20/50), in hCNV 69 ± 17 (20/40), in RAP 68 ± 12 (20/50), and in PED 69 ± 18 (20/40). At the 12-month follow-up, visual acuity improved or was stable (±5 letters from baseline) in 84% of eyes (37/44 patients), with hCNV showing the greatest mean visual acuity gain. Mean central retinal thickness in patients with PCV was 523 ± 251 µm, in hCNV 497 ± 171, in RAP lesions 573 ± 132, and in PED 541 ± 158 and decreased to 310 ± 91 µm in PCV, 323 ± 75 µm in hCNV, 357 ± 173 µm in RAP lesions, and 422 ± 150 µm in PED. The mean area of atrophy increased from 2.0 ± 3.6 mm2 at baseline to 4.6 ± 8.6 mm2 at Month 12 (mean difference [95% confidence interval] -0.8 [-8.5 to 7.0], P = 0.8), with the greatest atrophy in patients with PED at Month 12. All subtypes of neovascular age-related macular degeneration showed anatomical improvement and stabilization of visual function during intravitreal treatment.

Chirurgie combinée vitrectomie et phakoéxérèse avec implantation bag-in-the-lens (BIL) ou de sac : comparaison de l’acuité visuelle finale

Combined vitrectomy-lensectomy surgery is a safe and effective procedure. Nevertheless, it is frequently complicated by posterior capsule opacification and the formation of posterior synechiae. These complications can be avoided by placing a "bag in the lens" (BIL) implant. The objective of this study is to compare the visual acuity gain (VA) after combined vitrectomy-lensectomy surgery between a group implanted with the BIL technique and a group with implantation in the bag (LIB). We included in the study all vitrectomy-lensectomy procedures for epiretinal membrane and vitreomacular traction performed between May 2013 and July 2016 at the Hospital and University Center of Caen. We compared the VA gain between the BIL group and the LIB group six months after surgery. A total of 33 patients were included in the study, consisting of 28 eyes in the BIL group and 8 eyes in the LIB group. The mean VA gain in the BIL group was -0.52 LogMAR (P<0.0001) and -0.56 LogMAR (P=0.0047) for the LIB group. The difference between the two groups was not significant (P=0.74). The use of the BIL technique during vitrectomy-lensectomy allows visual recovery as good as implantation within the capsular bag. In addition, this implant has the advantage of significantly reducing the occurrence of posterior synechiae and preventing anterior and posterior capsular proliferation.

Real-World Effectiveness and Real-World Cost-Effectiveness of Intravitreal Aflibercept and Intravitreal Ranibizumab in Neovascular Age-Related Macular Degeneration: Systematic Review and Meta-Analysis of Real-World Studies.

IntroductionTreatment of neovascular age-related macular degeneration (nAMD) has evolved with the advent of anti-vascular endothelial growth factor agents such that intravitreally administered aflibercept and ranibizumab (RBZ) have become the standard of care. Randomized clinical trials (RCTs) have demonstrated the benefits of these agents in nAMD; however, results achieved under RCT protocols may not always be replicated in clinical practice. Assessing real-world outcomes is important to estimate the effectiveness and cost-effectiveness of these two agents. Our objective was to assess the real-world effectiveness of intravitreally administered aflibercept and RBZ in treatment-naive patients with nAMD and determine the cost-effectiveness of intravitreally administered aflibercept versus RBZ in a real-world setting.MethodsA multistage approach was undertaken. A systematic literature review (SLR) was completed to identify studies describing real-world outcomes in patients with nAMD treated intravitreally with aflibercept or RBZ. A meta-analysis of data identified in the SLR generated a pooled estimate of the effectiveness of intravitreally administered aflibercept and RBZ at 52 weeks and an estimate of treatment burden (injection frequency and monitoring). The impact of treatment effect modifiers, such as baseline visual acuity (VA) and age, were corrected through a multivariable meta-regression. A Markov state transition model was developed to estimate the real-world cost-effectiveness of intravitreally administered aflibercept using results from the pooled estimates for effectiveness and treatment burden as primary inputs. The analysis considered the perspective of the French National Healthcare System.ResultsPatients treated intravitreally with aflibercept had a mean age of 79.52 years and mean baseline VA of 55.80 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. At week 52, mean VA gain was 5.30 ETDRS letters in patients reporting an average of 7.10 intravitreal injections of aflibercept and 8.65 visits (injection and/or monitoring). RBZ-treated patients were younger (77.28 years), with a lower mean baseline VA (52.81 ETDRS letters). At week 52, mean VA gain from baseline was 4.24 ETDRS letters, with an average of 5.88 injections and 10.10 visits (injection and/or monitoring). After correcting for differences in age (77.28 years) and baseline VA (52.81 ETDRS letters) and considering the current clinical practice with aflibercept and RBZ, the mean VA gain was 6.57 ETDRS letters for patients treated intravitreally with aflibercept and 4.42 ETDRS for patients treated intravitreally with RBZ. The cost-effectiveness analysis showed that intravitreally administered aflibercept is a more effective treatment option with an incremental gain in quality-adjusted life years (QALYs) (4.918 versus 4.880) and an incremental cost-effectiveness ratio (ICER) of €27,087 per QALY.ConclusionsThe analysis identified differences in the overall treatment approach and how ophthalmologists use intravitreally administered aflibercept and RBZ in clinical practice. These differences ultimately influence the mean real-world effectiveness of the two agents. Intravitreal treatment with aflibercept (injection frequency and patients follow-up) was consistent and in line with the European label recommendations. Patients treated intravitreally with aflibercept in clinical practice reported a mean gain in VA of similar magnitude to the mean VA gain reported in the pivotal RCT. Conversely, treatment with RBZ varied significantly across the different studies. On average, RBZ-treated patients reported a low injection frequency and a frequent follow-up, driven in part by the high number of patients treated with pro re nata (PRN) regimens. RBZ-treated patients reported gains in VA versus baseline; however, the magnitude of the gain in VA was not comparable to the VA gains reported in the RBZ pivotal RCT. Intravitreal treatment with aflibercept was associated with better mean VA outcomes and an incremental gain in QALYs compared with RBZ and can be considered cost-effective for the treatment of nAMD in patients in France despite a higher price for each individual intravitreal injection of aflibercept compared with RBZ.FundingBayer AG, Basel.Electronic supplementary materialThe online version of this article (10.1007/s12325-019-01147-6) contains supplementary material, which is available to authorized users.

Ranibizumab in macular oedema secondary to branch retinal vein occlusion - 24 months of treatment.

To retrospectively evaluate the efficacy and safety of ranibizumab treatment for macular edema (ME) secondary to branch retina vein occlusion (BRVO) after 24 months. This study included 39 eyes of 39 patients with ME associated with BRVO treated at the Ophthalmology Department of Faculty Hospital in Hradec Kralove. The average age of included patiens was 69,3 years, the mean duration of symptoms before treament was 5,4 months, the mean baseline visual acuity (VA) was 54,6 ETDRS (Early Treatment Diabetic Retinopathy Study) letters, the mean baseline central retinal thickness (CRT) was 544,9µm. At 64,1% patients aretinal laserphotocoagulation was performed before intravitreal ranibizumab. After one year, the study was discontinued by 17 patiens, the remaining 22 patients were observed for 24 months. Initially, there were 3 doses of intravitreal ranibizumab administered in monthly intervals, further injections were applied according to PRN (pro re nata) regiment. Patients were examined at baseline and then at 3, 6, 9, 12 and 24 months from initiation of the treatment. In this study, the effect of ranibizumab on functional and morphological parameters of the affected eye was monitored, the safety of this treatment was also evaluated. During the follow-up, astatistically significant improvement in VA was achieved in every visit in comparison to baseline parameters, the mean VA gain at the 3 month visit was 12,1 ETDRS letters (p.