Efficacy of a novel personalised aflibercept monotherapy regimen based on polypoidal lesion closure in participants with polypoidal choroidal vasculopathy

2021 ◽  
pp. bjophthalmol-2020-318354
Author(s):  
Kelvin Yi Chong Teo ◽  
Janice Marie Jordan-Yu ◽  
Anna C S Tan ◽  
Ian Y S Yeo ◽  
Ranjana Mathur ◽  
...  
Keyword(s):  
Polypoidal Choroidal Vasculopathy ◽  
Open Label ◽  
Weekly Treatment ◽  
Central Subfield Thickness ◽  
Single Centre Study ◽  
Registration Number ◽  
Treatment Naïve ◽  
The Mean ◽  
To Receive ◽  
Choroidal Vasculopathy

PurposeTo compare the efficacy of aflibercept using a personalised versus fixed regimen in treatment-naïve participants with polypoidal choroidal vasculopathy (PCV).DesignA 52-week, randomised, open-label, non-inferiority, single-centre study that included participants with symptomatic PCV. Participants were randomised (3:1 ratio) to receive either personalised (n=40) or fixed 8-weekly treatment regimen (n=13). The personalised regimen allowed for either early treat and extend (T&E) after week 12 or late T&E with 3 additional 4-weekly aflibercept injections until week 24 in participants with residual polypoidal lesions (PL) on indocyanine green angiography (ICGA) at week 12.Main outcomes and measuresNon-inferiority of personalised to fixed regimen for mean change in best-corrected visual acuity (BCVA) from baseline to week 52 (non-inferiority margin: −5 letters). The key secondary outcomes include reduction in central subfield thickness (CSFT) on optical coherence tomography and the anatomical closure of PL on ICGA.ResultsOf the 53 participants, the mean (SD) age was 69.2 (8.1) years, 19 (35.8 %) were male. Personalised group was non-inferior to fixed for the primary end point (+8.1 vs +7.9 letters at week 52, respectively; difference 0.16, 95% CI −2.8 to 2.4, p=0.79). There was greater reduction in mean CSFT (SD) in the personalised versus fixed group (−248.8 (169.9) vs −164.8 (148.9) µm, p=0.03). Closure of PL occurred in 21 (55.2%) and 5 (41.6%) of study eyes in personalised and fixed groups, respectively at week 52 (p=0.41).ConclusionsPersonalised regimen achieved non-inferior BCVA gain and numerically higher PL closure compared with fixed regimen.Trial registration numberNCT03117634.

Six-year outcomes of antivascular endothelial growth factor monotherapy for polypoidal choroidal vasculopathy

2017 ◽  
Vol 102 (1) ◽  
pp. 97-101 ◽  
Author(s):  
Taiichi Hikichi
Keyword(s):  
Growth Factor ◽  
Polypoidal Choroidal Vasculopathy ◽  
Symptomatic Treatment ◽  
Continuous Treatment ◽  
Intravitreal Ranibizumab ◽  
Anti Vegf ◽  
Treatment Naïve ◽  
The Mean ◽  
Endothelial Growth Factor ◽  
Choroidal Vasculopathy

ObjectiveTo evaluate the 6-year outcomes of anti-VEGF (vascular endothelial growth factor) monotherapy for polypoidal choroidal vasculopathy (PCV).MethodsThe charts of 66 eyes of 66 patients with newly diagnosed, symptomatic, treatment-naive PCV were reviewed retrospectively. All patients were treated with 0.5 mg intravitreal ranibizumab (IVR) injections for 3 months followed by as-needed reinjections based on monthly examinations until 3 years after the first IVR injection. Thereafter, anti-VEGF monotherapy was continued for another 3 years.ResultsThe mean best-corrected visual acuity (BCVA) improved significantly (p=0.001) 3 months after the first IVR injection (0.24±0.30 logarithm of the minimum angle of resolution (logMAR) VA; 20/35 Snellen VA) compared with the baseline BCVA (0.34±0.37 logMAR VA; 20/44 Snellen VA). However, the improved VA returned to 0.32±0.39 logMAR unit (20/42 Snellen VA), which was not significantly different at 3 years. This level was maintained to the end of 6 years (0.36±0.37 logMAR unit; 20/46 Snellen VA). The mean numbers of anti-VEGF injections administered annually during 6 years were 5.6±2.4 (including the initial three monthly injections), 3.3±2.2, 3.3±2.9, 3.6±3.2, 3.5±2.9 and 3.3±2.7, respectively. The mean total number of injections during 6 years was 21.5±10.1.ConclusionsThe results emphasised the efficacy of anti-VEGF therapy for preserving vision and the limitations of anti-VEGF therapy in that continuous treatment is required over an extended follow-up period.

scholarly journals Initial treatment for polypoidal choroidal vasculopathy: Ranibizumab combined with photodynamic therapy or fixed-dosing aflibercept monotherapy

2019 ◽  
Vol 30 (6) ◽  
pp. 1473-1479 ◽  
Author(s):  
Ai Yoneda ◽  
Harumi Wakiyama ◽  
Junko Kurihara ◽  
Takashi Kitaoka
Keyword(s):  
Visual Acuity ◽  
Photodynamic Therapy ◽  
Combination Therapy ◽  
Polypoidal Choroidal Vasculopathy ◽  
Therapy Group ◽  
Intravitreal Ranibizumab ◽  
Intravitreal Aflibercept ◽  
Treatment Naïve ◽  
The Mean ◽  
Choroidal Vasculopathy

Purpose: To compare the 2-year outcomes of combination therapy using intravitreal ranibizumab and photodynamic therapy with those of fixed-dosing intravitreal aflibercept monotherapy as initial treatment for treatment-naïve polypoidal choroidal vasculopathy. Methods: We retrospectively reviewed 63 eyes of 61 patients with treatment-naïve polypoidal choroidal vasculopathy who had undergone at least 24 months of follow-up. In total, 43 eyes underwent intravitreal ranibizumab–photodynamic therapy combination therapy and 20 eyes underwent fixed-dosing intravitreal aflibercept monotherapy. Visual outcomes and the number of treatments were compared between the two groups. Results: The mean logarithm of minimal angle of resolution best-corrected visual acuity significantly improved from 0.48 ± 0.41 at baseline to 0.30 ± 0.47 at 24 months in the intravitreal ranibizumab–photodynamic therapy group ( p = .0002) and from 0.30 ± 0.18 at baseline to 0.16 ± 0.18 at 24 months in the intravitreal aflibercept group ( p = .004), with no significant intergroup differences. The mean number of intravitreal ranibizumab or intravitreal aflibercept injections over 24 months was 5.7 ± 4.5 in the intravitreal ranibizumab–photodynamic therapy group and 12.2 ± 3.8 in the intravitreal aflibercept group ( p < .0001). Conclusion: The intravitreal ranibizumab–photodynamic therapy combination therapy was noninferior to fixed-dosing intravitreal aflibercept monotherapy in improving visual acuity and required fewer injections.

scholarly journals Further improvement in glycemic control after switching from exenatide two times per day to exenatide once-weekly autoinjected suspension in patients with type 2 diabetes: 52-week results from the DURATION-NEO-1 study

2020 ◽  
Vol 8 (1) ◽  
pp. e000773
Author(s):  
Carol H Wysham ◽  
Julio Rosenstock ◽  
Marion L Vetter ◽  
Hui Wang ◽  
Elise Hardy ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Body Weight ◽  
Phase Iii ◽  
Open Label ◽  
Open Label Study ◽  
Registration Number ◽  
Efficacy Measures ◽  
Design And Methods ◽  
To Receive

IntroductionInvestigate the effects of switching from two times per day exenatide to once-weekly exenatide administered by autoinjector (exenatide once-weekly suspension by autoinjector (QWS-AI)) or treatment with exenatide QWS-AI for 1 year.Research design and methodsIn this phase III open-label study, adults with type 2 diabetes were randomized to receive exenatide QWS-AI (2 mg) or exenatide two times per day (5 mcg for 4 weeks, followed by 10 mcg) for 28 weeks. During a subsequent non-randomized 24-week extension, patients who received exenatide two times per day were switched to exenatide QWS-AI and those randomized to exenatide QWS-AI continued this treatment. Efficacy measures included changes from baseline in glycated hemoglobin (A1C), fasting plasma glucose (FPG), and body weight.ResultsIn total, 315 patients (mean baseline A1C of 8.5%) completed the initial 28 weeks of randomized treatment with exenatide QWS-AI (n=197) or exenatide two times per day (n=118) and were included in the 24-week extension (mean A1C of 7.0% and 7.3%, respectively, at week 28). From weeks 28–52, patients who switched from exenatide two times per day to exenatide QWS-AI had additional A1C reductions of approximately 0.5% (mean A1C change from baseline of –1.4% at week 52) and further reductions from baseline in FPG. Patients who continued exenatide QWS-AI treatment for 52 weeks showed clinically relevant A1C reductions (mean A1C change from baseline of –1.3% at week 52). Body-weight reductions achieved through week 28 were sustained at week 52 in both groups. There were no unexpected safety concerns or changes in the safety profile among patients who switched from exenatide two times per day to exenatide QWS-AI or those who continued exenatide QWS-AI treatment for 52 weeks.ConclusionsSwitching from exenatide two times per day to exenatide QWS-AI resulted in further A1C reductions and maintenance of earlier decreases in body weight, while continued therapy with exenatide QWS-AI for 52 weeks maintained A1C and body-weight reductions, without additional safety or tolerability concerns.Trial registration numberNCT01652716.

scholarly journals One-year outcomes of fixed-dosing Aflibercept therapy for pre treated and naive polypoidal choroidal vasculopathy patient

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hun Gu Choo ◽  
Jin Hae Lee ◽  
Hyun Sub Oh ◽  
Soon Hyun Kim ◽  
Yong Sung You ◽  
...  
Keyword(s):  
Polypoidal Choroidal Vasculopathy ◽  
Vision Loss ◽  
Case Series ◽  
Age Related Macular Degeneration ◽  
Research Information ◽  
Age Related ◽  
Case Series Study ◽  
Treatment Naïve ◽  
One Year ◽  
Choroidal Vasculopathy

Abstract Background Polypoidal choroidal vasculopathy (PCV) is a type of age-related macular degeneration that can cause permanent vision loss. The purpose of this paper was to report the one-year outcomes of fixed-dosing aflibercept therapy for the treatment of PCV. Methods This was a prospective, single-arm, interventional case series study of 25 PCV patients; 12 pre-treated and 13 treatment-naïve patients. The patients were treated and monitored for 12 months. Each patient was administered with an aflibercept (2.0 mg) injection every month for the first 3 months (the loading phase), and thereafter, once every 2 months. At every follow-up visit, best-corrected visual acuity (BCVA) test, fundus examination, and optical coherence tomography for measuring the central subfield macular thickness (CSMT) were performed. Fluorescein and indocyanine green angiography were conducted at baseline and at 4 and 12 months. Results After 12 months of aflibercept therapy, the mean BCVA of the patients significantly improved from 65.48 letters at baseline to 69.91 letters (p=0.001), and the CSMT significantly decreased from 406.92 um at baseline to 276.12 um (p< 0.001). Additionally, ten patients (40%) showed complete polyp regression. The treatment-naïve patients showed a statistically significant improvement in BCVA from 66.58 letters at baseline to 76.36 letters at 12 months, and a significant decrease in CSMT, from 462 to 243 um. In the pre-treated group, there was no change in BCVA (64.46 letters), and the decrease in CSMT from 356.08 to 303.69 um was not statistically significant. Conclusions The fixed-dosing aflibercept regimen is effective for treating patients with PCV and is more effective in treatment-naïve patients than in pre-treated patients. Trial registration Clinical Research Information Service (CRiS), Republic of Korea. Identifer: KCT0005798, Registered: Jan 20, 2021. Retrospectively registered, URL: https://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=18546

Comparison of the Effectiveness and Prognostic Factors of Intravitreal Ranibizumab between Typical Neovascular Age-Related Macular Degeneration and Polypoidal Choroidal Vasculopathy over 24 Months of Follow-Up

2015 ◽  
Vol 234 (1) ◽  
pp. 33-39 ◽  
Author(s):  
Wataru Matsumiya ◽  
Shigeru Honda ◽  
Keiko Otsuka ◽  
Akiko Miki ◽  
Takayuki Nagai ◽  
...  
Keyword(s):  
Macular Degeneration ◽  
Polypoidal Choroidal Vasculopathy ◽  
Age Related Macular Degeneration ◽  
Morphological Parameters ◽  
Intravitreal Ranibizumab ◽  
Corrected Visual Acuity ◽  
Age Related ◽  
The Mean ◽  
Choroidal Vasculopathy

Purpose: To compare the response to ranibizumab between patients with typical neovascular age-related macular degeneration (tAMD) and those with polypoidal choroidal vasculopathy (PCV), and to determine the predictors for the outcomes. Methods: Fifty-nine eyes from 59 consecutive patients (tAMD: 27 eyes, PCV: 32 eyes) were treated with three monthly ranibizumab injections followed by as-needed retreatment. Best-corrected visual acuity (BCVA) and morphological parameters were evaluated over 24 months of follow-up. Results: The mean BCVA in tAMD and PCV patients was significantly improved at 3 months (-0.22 and -0.09 logMAR units, respectively). The improvement in BCVA was sustained up to 24 months in tAMD (p = 0.01) but not in PCV patients. The significant predictor for good response to ranibizumab in tAMD patients was the improvement of BCVA at 3 months, whereas that in PCV patients was the anatomical resolution at 3 months. Conclusions: Ranibizumab is an effective therapy for tAMD and PCV over 24 months. The predictors for good outcome might be different between tAMD and PCV.

scholarly journals Five-year visual outcomes after anti-VEGF therapy with or without photodynamic therapy for polypoidal choroidal vasculopathy

2018 ◽  
Vol 103 (5) ◽  
pp. 617-622 ◽  
Author(s):  
Manabu Miyata ◽  
Sotaro Ooto ◽  
Kenji Yamashiro ◽  
Hiroshi Tamura ◽  
Masayuki Hata ◽  
...  
Keyword(s):  
Photodynamic Therapy ◽  
Combination Therapy ◽  
Polypoidal Choroidal Vasculopathy ◽  
Fundus Photography ◽  
Combination Group ◽  
Macular Atrophy ◽  
Anti Vegf ◽  
Significant Difference ◽  
Treatment Naïve ◽  
Choroidal Vasculopathy

Background/aimsTo evaluate the 5-year visual and anatomical outcomes after anti-vascular endothelial growth factor (VEGF) therapy alone or in combination with photodynamic therapy (PDT), followed by pro re nata (PRN) anti-VEGF therapy with or without PDT, for polypoidal choroidal vasculopathy (PCV).MethodsThis retrospective, observational study included 61 consecutive patients with treatment-naïve symptomatic PCV who were followed for 5 years. Twenty eyes (20 patients) initially received PDT and intravitreal injection of ranibizumab (IVR), followed by a PRN regimen of anti-VEGF therapy with or without PDT (combination group), while 41 eyes (41 patients) initially received only IVR every 3 months, followed by a PRN regimen of anti-VEGF monotherapy (IVR group). Macular atrophy including the fovea was confirmed using colour fundus photography and spectral-domain optical coherence tomography.ResultsIn both groups, the visual acuity (VA) at 1 year was better than the baseline VA, whereas the 3-year, 4-year and 5-year VA values were similar to the baseline VA. There was no significant difference in the 5-year VA, 5-year central retinal thickness and incidence of macular atrophy between the two groups (p=0.63, 0.72 and 0.06, respectively). In the combination group, the 5-year VA was correlated with the 5-year incidence of macular atrophy (p=0.02, r=0.51).ConclusionsA PRN regimen for PCV may have a limited effect for the long-term maintenance of improved VA. Macular atrophy may occur more frequently with combination therapy and is possibly associated with the 5-year VA. Thus, combination therapy should be carefully selected for patients susceptible to macular atrophy.

Phenotypic and genetic variations between Asian and Caucasian polypoidal choroidal vasculopathy

2020 ◽  
pp. bjophthalmol-2020-317537
Author(s):  
Janice Marie Jordan-Yu ◽  
Kelvin Teo ◽  
Qiao Fan ◽  
Jose Carlos Gana ◽  
Anna Karina Leopando ◽  
...  
Keyword(s):  
Polypoidal Choroidal Vasculopathy ◽  
Genetic Variations ◽  
Fundus Photography ◽  
Imaging Features ◽  
Nucleotide Polymorphisms ◽  
Asian Patients ◽  
Cohort Differences ◽  
Treatment Naïve ◽  
Lower Ratio ◽  
Choroidal Vasculopathy

PurposeTo compare phenotypic and genetic variations in polypoidal choroidal vasculopathy (PCV) between Caucasian and Asian patients.MethodsWe analysed phenotypic and genotypic data from two sites, Association for Innovation and Biomedical Research on Light and Image, Portugal and Singapore National Eye Centre, Singapore. Baseline fundus photography, spectral domain-optical coherence tomography, indocyanine green and fluorescein angiography scans were analysed by respective reading centres using a standardised grading protocol. Single nucleotide polymorphisms across 8 PCV loci were compared between cases and controls selected from each population.ResultsOne hundred and forty treatment-naïve PCV participants (35 Portuguese and 105 Singaporean) were included. The Portuguese cohort were older (72.33±8.44 vs 68.71±9.40 years, p=0.043) and were comprised of a lower proportion of males (43% vs 71%, p=0.005) compared with the Singaporean cohort. Differences in imaging features include higher prevalence of soft drusen (66% vs 30%, p=0.004), lower prevalence of subretinal haemorrhage (14% vs 67%, p<0.001), smaller polypoidal lesion (PL) area (0.09±0.09 vs 0.76±0.93 mm2, p<0.001), lower ratio of PL to branching vascular network area (3% vs 38%, p<0.001) and lower central retinal thickness (346.48±93.74 vs 493.16±212.92 µm, p<0.001) in the Portuguese cohort. CETP rs3764261 (OR 2.467; 95% CI 1.282 to 4.745, p=0.006) in the Portuguese population was significantly associated with PCV and CFH rs800292 (OR 1.719; 95% CI 1.139 to 2.596, p=0.010) in the Singaporean population, respectively.ConclusionAmong Asian and Caucasian patients with PCV, there are significant differences in the expression of phenotype. We also identified different polymorphisms associated with PCV in the two populations.

Stereotactic Radiotherapy for Polypoidal Choroidal Vasculopathy: A Pilot Study

2014 ◽  
Vol 233 (2) ◽  
pp. 82-88 ◽  
Author(s):  
Ugo Introini ◽  
Giuseppe Casalino ◽  
Giacinto Triolo ◽  
Denis O''Shaughnessy ◽  
E. Mark Shusterman ◽  
...  
Keyword(s):  
Adverse Events ◽  
Stereotactic Radiotherapy ◽  
Polypoidal Choroidal Vasculopathy ◽  
Low Voltage ◽  
Secondary Outcome ◽  
Intravitreal Ranibizumab ◽  
Foveal Thickness ◽  
X Ray ◽  
The Mean ◽  
Choroidal Vasculopathy

Purpose: To evaluate low-voltage X-ray stereotactic radiotherapy (SRT) delivered in conjunction with intravitreal ranibizumab for the treatment of active macular polypoidal choroidal vasculopathy (PCV). Methods: At baseline, all eyes received an intravitreal injection of ranibizumab, followed by 16-Gy X-ray SRT to the macula. Further ranibizumab injections were given pro re nata. The primary outcome measure was regression of the polyps assessed by indocyanine green angiography. Secondary outcome measures were best-corrected visual acuity (BCVA) and central foveal thickness (CFT) changes on optical coherence tomography. Local or systemic adverse events were evaluated as well. Results: We examined 12 eyes of 12 patients with PCV. At month 12, an angiographic regression of the polyps was observed in 10 of the 12 eyes. The mean BCVA improved by 7.6 letters: from 65.08 ± 11.4 to 72.7 ± 14.75 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The mean CFT decreased from 372.3 ± 79.6 to 215.9 ± 57.9 µm (p < 0.01). No local or systemic adverse events were reported. Conclusions: The preliminary data support the safety of low-voltage X-ray SRT for the treatment of macular PCV and show polyp closure, reduction in CFT and improvement in the mean BCVA. Additional research is warranted to confirm the efficacy and longer-term safety of this therapy in this population.

scholarly journals Quantitative analysis of choroidal vasculature in polypoidal choroidal vasculopathy using ultra-widefield indocyanine green angiography

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Gahyung Ryu ◽  
Cheolwon Moon ◽  
Jano van Hemert ◽  
Min Sagong
Keyword(s):  
Indocyanine Green ◽  
Treatment Response ◽  
Polypoidal Choroidal Vasculopathy ◽  
Indocyanine Green Angiography ◽  
Vascular Density ◽  
Poor Treatment ◽  
Treatment Naïve ◽  
Healthy Control ◽  
Choroidal Vasculature ◽  
Choroidal Vasculopathy

Abstract Polypoidal choroidal vasculopathy (PCV) is a common choroidal vascular disease particularly in Asians. However, the underlying pathogenesis of PCV is still yet to be fully elucidated, and the correlation between choroidal vasculature and treatment response of PCV are poorly understood. Accordingly, we sought to find clues to understand the pathogenesis and prognosis of PCV by quantitatively evaluating choroidal vasculature from the entire fundus using ultra-widefield (UWF) indocyanine green angiography (ICGA). In this study, 32 eyes from 29 patients with treatment naïve PCV and 30 eyes from 30 healthy control participants were enrolled. Choroidal vascular density (CVD) of PCV eyes was higher than normal eyes in majority regions including the periphery. CVD was positively correlated with choroidal thickness and choroidal hyperpermeability, supporting that the pathogenesis of PCV may include choroidal congestion and dilatation. Thicker choroid and higher CVD were also correlated with poor treatment response after anti-VEGF injections. The CVD, quantified from UWF ICGA can also be used as an effective image biomarker to predict the treatment response in PCV.

scholarly journals Comparison of cytokine levels in the aqueous humor of polypoidal choroidal vasculopathy and neovascular age-related macular degeneration patients

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Huiying Zhou ◽  
Xinyu Zhao ◽  
Mingzhen Yuan ◽  
Youxin Chen
Keyword(s):  
Macular Degeneration ◽  
Aqueous Humor ◽  
Polypoidal Choroidal Vasculopathy ◽  
Age Related Macular Degeneration ◽  
Logistic Analysis ◽  
Age Related ◽  
Cytokine Levels ◽  
Treatment Naïve ◽  
And Control ◽  
Choroidal Vasculopathy

Abstract Background The concentrations of cytokines in the aqueous humor from neovascular age-related macular degeneration (nAMD) and polypoidal choroidal vasculopathy (PCV) may vary. The study was conducted to compare various cytokine levels in the aqueous humor of eyes with PCV, nAMD and control. Methods The present case control study included 49 treatment-naïve eyes from 49 patients (PCV 24, nAMD 11, and cataract 14 eyes). Totally 34 angiogenic and inflammatory cytokines in the aqueous humor were measured by Luminex bead-based multiplex array. Results After adjusting for gender and age by multivariate logistic analysis, concentrations of IL-31, LIF, SDF1-α, VEGF-A, VEGF-D were significantly higher in eyes with nAMD or PCV compared with control eyes (all P < 0.05, times in nAMD: 59.5, 6.0, 7.0, 4.5, 5.6, respectively, times in PCV: 51.9, 5.21, 6.6, 4.0, 5.1, respectively), and concentrations of HGF, IP-10, MCP-1, IL-13 were significantly lower in eyes with nAMD or PCV than in control eyes (all P < 0.05, times in nAMD: 2.6, 2.0, 4.5, 4.7, respectively, times in PCV: 1.9, 3.0, 3.0, 2.8, respectively), but none of the 34 cytokines, including VEGF and IL-8, showed significantly different between eyes with nAMD and PCV. Conclusions Various cytokines involved in inflammation and angiogenesis including elevated IL-31, LIF, SDF1-α, VEGF-A, VEGF-D might be involved in the pathogenesis of nAMD or PCV. None of the 34 cytokines may help to differentiate nAMD and PCV.

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