scholarly journals Intravitreal ranibizumab versus aflibercept versus bevacizumab for macular oedema due to central retinal vein occlusion: the LEAVO non-inferiority three-arm RCT

2021 ◽  
Vol 25 (38) ◽  
pp. 1-196
Author(s):  
Philip Hykin ◽  
A Toby Prevost ◽  
Sobha Sivaprasad ◽  
Joana C Vasconcelos ◽  
Caroline Murphy ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Cost Effectiveness ◽  
Confidence Interval ◽  
Retinal Vein Occlusion ◽  
Central Retinal Vein Occlusion ◽  
Intention To Treat ◽  
Vein Occlusion ◽  
Corrected Visual Acuity ◽  
Central Retinal Vein ◽  
Best Corrected Visual Acuity

Background Licensed ranibizumab (0.5 mg/0.05 ml Lucentis®; Novartis International AG, Basel, Switzerland) and aflibercept (2 mg/0.05 ml Eylea®; Bayer AG, Leverkusen, Germany) and unlicensed bevacizumab (1.25 mg/0.05 ml Avastin®; F. Hoffmann-La Roche AG, Basel, Switzerland) are used to treat macula oedema due to central retinal vein occlusion, but their relative clinical effectiveness, cost-effectiveness and impact on the UK NHS and Personal Social Services have never been directly compared over the typical disease treatment period. Objective The objective was to compare the clinical effectiveness and cost-effectiveness of three intravitreal antivascular endothelial growth factor agents for the management of macula oedema due to central retinal vein occlusion. Design This was a three-arm, double-masked, randomised controlled non-inferiority trial. Setting The trial was set in 44 UK NHS ophthalmology departments, between 2014 and 2018. Participants A total of 463 patients with visual impairment due to macula oedema secondary to central retinal vein occlusion were included in the trial. Interventions The participants were treated with repeated intravitreal injections of ranibizumab (n = 155), aflibercept (n = 154) or bevacizumab (n = 154). Main outcome measures The primary outcome was an increase in the best corrected visual acuity letter score from baseline to 100 weeks in the trial eye. The null hypothesis that aflibercept and bevacizumab are each inferior to ranibizumab was tested with a non-inferiority margin of –5 visual acuity letters over 100 weeks. Secondary outcomes included additional visual acuity, and imaging outcomes, Visual Function Questionnaire-25, EuroQol-5 Dimensions with and without a vision bolt-on, and drug side effects. Cost-effectiveness was estimated using treatment costs and Visual Function Questionnaire-Utility Index to measure quality-adjusted life-years. Results The adjusted mean changes at 100 weeks in the best corrected visual acuity letter scores were as follows – ranibizumab, 12.5 letters (standard deviation 21.1 letters); aflibercept, 15.1 letters (standard deviation 18.7 letters); and bevacizumab, 9.8 letters (standard deviation 21.4 letters). Aflibercept was non-inferior to ranibizumab in the intention-to-treat population (adjusted mean best corrected visual acuity difference 2.23 letters, 95% confidence interval –2.17 to 6.63 letters; p = 0.0006), but not superior. The study was unable to demonstrate that bevacizumab was non-inferior to ranibizumab in the intention-to-treat population (adjusted mean best corrected visual acuity difference –1.73 letters, 95% confidence interval –6.12 to 2.67 letters; p = 0.071). A post hoc analysis was unable to demonstrate that bevacizumab was non-inferior to aflibercept in the intention-to-treat population (adjusted mean best corrected visual acuity difference was –3.96 letters, 95% confidence interval –8.34 to 0.42 letters; p = 0.32). All per-protocol population results were the same. Fewer injections were required with aflibercept (10.0) than with ranibizumab (11.8) (difference in means –1.8, 95% confidence interval –2.9 to –0.8). A post hoc analysis showed that more bevacizumab than aflibercept injections were required (difference in means 1.6, 95% confidence interval 0.5 to 2.7). There were no new safety concerns. The model- and trial-based cost-effectiveness analyses estimated that bevacizumab was the most cost-effective treatment at a threshold of £20,000–30,000 per quality-adjusted life-year. Limitations The comparison of aflibercept and bevacizumab was a post hoc analysis. Conclusion The study showed aflibercept to be non-inferior to ranibizumab. However, the possibility that bevacizumab is worse than ranibizumab and aflibercept by 5 visual acuity letters cannot be ruled out. Bevacizumab is an economically attractive treatment alternative and would lead to substantial cost savings to the NHS and other health-care systems. However, uncertainty about its relative effectiveness should be discussed comprehensively with patients, their representatives and funders before treatment is considered. Future work To obtain extensive patient feedback and discuss with all stakeholders future bevacizumab NHS use. Trial registration Current Controlled Trials ISRCTN13623634. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 38. See the NIHR Journals Library website for further project information.

scholarly journals Predictors of visual recovery in patients with macular edema secondary to central retinal vein occlusion after treatment with Conbercept

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Qi Zhang ◽  
Yinfen Hou ◽  
Xiao Cao ◽  
Rongrong Zhang ◽  
Yinping Liu ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Edema ◽  
Intravitreal Injection ◽  
Layer Thickness ◽  
Central Retinal Vein Occlusion ◽  
Vein Occlusion ◽  
Corrected Visual Acuity ◽  
Central Retinal Vein ◽  
Best Corrected Visual Acuity

Abstract Background The use of Spectral domain optical coherence tomography (SD-OCT) to evaluate the predictors of visual acuity-recovery in patients treated with conbercept for macular edema (ME) secondary to central retinal vein occlusion (CRVO) has rarely been seen. We collected 26 CRVO-ME patients with different OCT measures at 6 months follow-up to identify the factors that are most strongly correlated with the best-corrected visual acuity (BCVA) post-treatment in CRVO-ME patients treated with conbercept. Purpose To evaluate the effectiveness of intravitreal conbercept injections for the treatment of CRVO-ME and to determine the major predictors of best-corrected visual acuity (BCVA) post-treatment. Methods A retrospective study methodology was used. Twenty-six eyes from 26 patients with CRVO-ME were enrolled in the study. After an initial intravitreal injection of conbercept (0.5 mg/0.05 ml), monthly injections for up to 6 months were given following a 1 + PRN (pro re nata) regimen. Data collected at monthly intervals included measurements of the logMAR BCVA, central subfield thickness (CST), macular volume (MV), photoreceptor layer thickness (PLT), outer nuclear layer thickness (ONLT), and the disrupted ellipsoid zone (DEZ). The correlation between BCVA, before and after injections, and each of CST, MV, PLT, ONLT, DEZ was analyzed. Results The logMAR BCVA in months 3 and 6 post-injection was significantly improved relative to the baseline. In this same period the CST, MV, PLT, ONLT and DEZ were also significantly improved relative to the baseline. There was a negative correlation between PLT and logMAR BCVA at months 3 and 6 after treatment (r = − 0.549, P < 0.001; r = − 0.087, P < 0.001). Conclusion Intravitreal injection of conbercept is an effective treatment for CRVO-ME. With 6 months of follow-up, logMAR BCVA and CST, MV, PLT, ONLT, DEZ improved. PLT was negatively correlated with the visual function in CRVO-ME patients after conbercept treatment, which may be a predictor of vision recovery in patients with CRVO-ME.

scholarly journals Efficacy and Safety of an Aflibercept Treat-and-Extend Regimen in Treatment-Naïve Patients with Macular Oedema Secondary to Central Retinal Vein Occlusion (CRVO): A Prospective 12-Month, Single-Arm, Multicentre Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-7
Author(s):  
Jose Garcia-Arumi ◽  
Francisco Gómez-Ulla ◽  
Navea Amparo ◽  
Enrique Cervera ◽  
Alex Fonollosa ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Retinal Vein Occlusion ◽  
Central Retinal Vein Occlusion ◽  
Macular Oedema ◽  
Efficacy And Safety ◽  
Foveal Thickness ◽  
Treat And Extend ◽  
Vein Occlusion ◽  
Treatment Naïve ◽  
Central Retinal Vein

Objectives. To evaluate efficacy and safety of an aflibercept treat-and-extend (TAE) regimen in patients with macular oedema (MO) secondary to central retinal vein occlusion (CRVO). Design, Setting, and Patients. Phase IV, prospective, open-label, single-arm trial in 11 Spanish hospitals. Treatment-naïve patients with <6 month diagnosis of MO secondary to CRVO and best-corrected visual acuity (BCVA) of 73-24 ETDRS letters were included between 23 January 2015 and 17 March 2016. Intervention. Intravitreal aflibercept 2 mg monthly (3 months) followed by proactive individualized dosing. Main Outcomes. Mean change in BCVA after 12 months. Results. 24 eyes (24 patients) were included; mean (SD) age: 62.8 (15.0) years; 54.2% male; median (IQR) time since diagnosis: 7.6 (3.0, 15.2) days. Mean BCVA scores significantly improved between baseline (56.0 (16.5)) and Month 12 (74.1 (17.6)); mean (95% CI) change: 14.8 (8.2, 21.4); P=0.0001. Twelve (50.0%) patients gained ≥15 ETDRS letters. Foveal thickness improved between baseline (mean: 569.4 (216.8) µm) and Month 12 (mean 257.4 (48.4) µm); P<0.0001. At Month 12, 8.3% patients had MO. The mean (SD) number of injections: 8.3 (3.0). No treatment-related AEs were reported. Five (20.8%) patients experienced ocular AEs. Two nonocular serious AEs were reported. Conclusions. An aflibercept TAE regimen improves visual acuity in patients with MO secondary to CRVO over 12 months with good tolerability.

scholarly journals Subthreshold Micropulse Photocoagulation for Persistent Macular Edema Secondary to Branch Retinal Vein Occlusion including Best-Corrected Visual Acuity Greater Than 20/40

2014 ◽  
Vol 2014 ◽  
pp. 1-10 ◽  
Author(s):  
Keiji Inagaki ◽  
Kishiko Ohkoshi ◽  
Sachiko Ohde ◽  
Gautam A. Deshpande ◽  
Nobuyuki Ebihara ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Edema ◽  
Retinal Vein Occlusion ◽  
Branch Retinal Vein Occlusion ◽  
Disease Onset ◽  
Vein Occlusion ◽  
Corrected Visual Acuity ◽  
Group I ◽  
Group Ii ◽  
Best Corrected Visual Acuity

To assess the efficacy of subthreshold micropulse diode laser photocoagulation (SMDLP) for persistent macular edema secondary to branch retinal vein occlusion (BRVO), including best-corrected visual acuity (BCVA) > 20/40, thirty-two patients (32 eyes) with macular edema secondary to BRVO were treated by SMDLP. After disease onset, all patients had been followed for at least 6 months prior to treatment. Baseline Snellen visual acuity was used to categorize the eyes as BCVA ≤ 20/40 (Group I) or BCVA > 20/40 (Group II). Main outcome measures were reduction in central macular thickness (CMT) in optical coherence tomography (OCT) and BCVA at 6 months. In the total subject-pool at 6 months, BCVA had not changed significantly but CMT was significantly reduced. Group I exhibited no significant change in CMT at 3 months but exhibited significant reductions at 6 and 12 months. Group II exhibited a marginally significant reduction in CMT at 3 months and a significant reduction at 6 months. In patients with persistent macular edema secondary to BRVO, SMDLP appears to control macular edema with minimal retinal damage. Our findings suggest that SMDLP is an effective treatment method for macular edema in BRVO patients with BCVA > 20/40.

scholarly journals Spectral domain optical coherence tomography (SD OCT) pattern of macular edema and visual acuity in recent-onset branch retinal vein occlusion (BRVO) in a tertiary hospital

2018 ◽  
Vol 7 (3) ◽  
pp. 89-93
Author(s):  
Kiran Shakya ◽  
Ram Prasad Pokhrel ◽  
Om Krishna Malla
Keyword(s):  
Visual Acuity ◽  
Macular Edema ◽  
Retinal Vein Occlusion ◽  
Branch Retinal Vein Occlusion ◽  
Spectral Domain ◽  
Hypertensive Group ◽  
Vein Occlusion ◽  
Corrected Visual Acuity ◽  
Stage 1 ◽  
Best Corrected Visual Acuity

Background: Macular edema is the common sight-threatening condition following branch retinal vein occlusion. Objective: To find spectral domain optical coherence tomography characteristics of macular involvement and visual acuity in the patients with branch retinal vein occlusion Methodology: This is a cross-sectional study; consecutive new cases of branch retinal vein occlusion diagnosed at the ophthalmology department of Kathmandu Medical College, Kathmandu were carried out from November 2016 to October 2017. All subjects were divided three groups with normotensive/controlled hypertension, stage 1 hypertension (systolic pressure >140 mm Hg or diastolic pressure >90mm Hg) and Stage 2 hypertension (systolic pressure >160 mm Hg or diastolic pressure >100 mm Hg).The macular edema was evaluated by taking best corrected visual acuity and spectral domain optical coherence tomography for measurement of central foveal thickness. Results: Forty patients with forty eyes were enrolled. Mean age was 58.5 years SD ± 9.98 years. Stage 1 and stage 2 hypertensive groups had significantly worse best corrected visual acuity and more thickness of central foveal thickness than normotensive/controlled group (p<0.001). The best corrected visual acuity and central foveal thickness were successively worse among normotensive group, stage 1 hypertensive group and stage 2 hypertensive group (between normotensive/controlled group and stage 1 hypertensive group, p = 0.032 and 0.002 respectively and between stage I hypertensive group and stage 2 hypertensive group, p= 0.013 and 0.09 respectively). Conclusion: Control of hypertension could be a main contributing measure to lower incidence of branch retinal vein occlusion and the severity of macular edema.

scholarly journals A 12-month, multicenter, parallel group comparison of dexamethasone intravitreal implant versus ranibizumab in branch retinal vein occlusion

2018 ◽  
Vol 28 (6) ◽  
pp. 697-705 ◽  
Author(s):  
Francesco Bandello ◽  
Albert Augustin ◽  
Adnan Tufail ◽  
Richard Leaback
Keyword(s):  
Visual Acuity ◽  
Retinal Vein Occlusion ◽  
Branch Retinal Vein Occlusion ◽  
Dexamethasone Intravitreal Implant ◽  
Vein Occlusion ◽  
Corrected Visual Acuity ◽  
Increased Risk ◽  
Intravitreal Implant ◽  
The Mean ◽  
Best Corrected Visual Acuity

Purpose: Dexamethasone intravitreal implant and intravitreal ranibizumab are indicated for the treatment of macular edema secondary to retinal vein occlusion. This non-inferiority study compared dexamethasone with ranibizumab in patients with branch retinal vein occlusion. Methods: In this randomized, 12-month head-to-head comparison, subjects with branch retinal vein occlusion were assigned to dexamethasone 0.7 mg at day 1 and month 5 with the option of retreatment at month 10 or 11, or ranibizumab 0.5 mg at day 1 and monthly through month 5 with subsequent as-needed injections at month 6–month 11. The primary efficacy outcome was the mean change from baseline in best-corrected visual acuity at month 12; secondary outcomes included average change in best-corrected visual acuity, proportion of eyes with ≥10- and ≥15-letter gain/loss, change in central retinal thickness, and change in Vision Functioning Questionnaire-25 score. Results: In all, 307 of a planned 400 patients were enrolled in the study and received (mean) 2.5 dexamethasone injections (n = 154) and 8.0 ranibizumab injections (n = 153) over 12 months. The mean change from baseline in best-corrected visual acuity at month 12 was 7.4 letters for dexamethasone versus 17.4 letters for ranibizumab (least-squares mean difference (dexamethasone minus ranibizumab), −10.1 letters; 95% confidence interval, −12.9, −7.2; p = 0.0006). Conclusion: Dexamethasone and ranibizumab improved best-corrected visual acuity and anatomical outcomes; however, dexamethasone did not show non-inferiority to ranibizumab in this under-powered study. Dexamethasone was associated with an increased risk of intraocular pressure elevation and cataract progression, but a lower injection burden, compared to ranibizumab.

scholarly journals Frosted Branch Angiitis Secondary to Familial Mediterranean Fever Resembling Central Retinal Vein Occlusion

2016 ◽  
Vol 2016 ◽  
pp. 1-4 ◽  
Author(s):  
Serdar Ozates ◽  
Pınar Çakar Ozdal ◽  
Mehmet Yasin Teke
Keyword(s):  
Visual Acuity ◽  
Familial Mediterranean Fever ◽  
Retinal Vein Occlusion ◽  
Central Retinal Vein Occlusion ◽  
Vision Loss ◽  
Retinal Vasculitis ◽  
Frosted Branch Angiitis ◽  
Vein Occlusion ◽  
Mediterranean Fever ◽  
Central Retinal Vein

Purpose. To report a case of unilateral frosted branch angiitis (FBA) resembling central retinal vein occlusion associated with Familial Mediterranean Fever (FMF). Case Report. A 32-year-old woman presented with progressive, painless vision loss in her left eye lasting for 2 days. She was clinically diagnosed with FMF 2 months ago. The best-corrected visual acuity (BCVA) was 20/20 in her right eye and there was light perception in the left. Ophthalmologic examination revealed severe retinal vasculitis showing clinical features of FBA in the left eye. 64 mg/day oral methylprednisolone was started. A significant improvement in retinal vasculitis was observed in two weeks. However, BCVA did not increase significantly due to subhyaloid premacular hemorrhage. Argon laser posterior hyaloidotomy was performed. One week after hyaloidotomy, visual acuity improved to 20/20 and intravitreal hemorrhage disappeared. Four months after the first attack, FBA recurred. Oral methylprednisolone dosage was increased to 64 mg/day and combined with azathioprine 150 mg. At the end of 12-month follow-up, the BCVA was 20/25 and development of epiretinal membrane was observed in the left eye. Conclusions. Frosted branch angiitis may occur with gene abnormalities as an underlying condition. Our case showed that FMF might be a causative disease.

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