scholarly journals Short-term Outcomes of Refractory Diabetic Macular Edema Switch from Ranibizumab to Dexamethasone Implant and the Influential Factors: A Retrospective Real World Experience.

2020 ◽  
Author(s):  
Ning-Yi Hsia ◽  
Chun-Ju Lin ◽  
Huan-Sheng Chen ◽  
Cheng-Hsien Chang ◽  
Henry Bair ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Real World ◽  
Influential Factors ◽  
Intravitreal Ranibizumab ◽  
Serious Adverse Events ◽  
Refractory Diabetic Macular Edema ◽  
The Mean ◽  
Intravitreal Dexamethasone

Abstract Background: To evaluate the effectiveness and safety of intravitreal dexamethasone (DEX) implants in refractory diabetic macular edema (DME) treated by intravitreal ranibizumab.Methods: We retrospectively analyzed DME patients who received DEX implant treatment after being unresponsive to at least three monthly intravitreal ranibizumab injections. The main outcomes were best-corrected visual acuity (BCVA), central retinal thickness (CRT), and intraocular pressure (IOP).Results: Twenty-nine eyes of 26 patients who had previously received an average of 8.1 ± 4.4 ranibizumab injections were included. Patients received between one and three DEX implants during 12.4 ± 7.4 months of follow-up. The mean final CRT significantly decreased from 384.4 ± 114.4 μm at baseline to 323.9 ± 77.7 μm (p = 0.0249). The mean final BCVA was 51.4 ± 21.3 letters, which was not significant compared to baseline (44.9 ± 30.2 letters, p = 0.1149). Mean IOP did not increase significantly. All patients tolerated the treatment well without serious adverse events. Higher baseline CRT and worse BCVA correlated with better therapeutic responses.Conclusion: Switching to DEX implant is effective and safe for treating DME non-responder to intravitreal ranibizumab in real world.

scholarly journals Short-Term Outcomes of Refractory Diabetic Macular Edema Switch From Ranibizumab to Dexamethasone Implant and the Influential Factors: A Retrospective Real World Experience

2021 ◽  
Vol 8 ◽  
Author(s):  
Ning-Yi Hsia ◽  
Chun-Ju Lin ◽  
Huan-Sheng Chen ◽  
Cheng-Hsien Chang ◽  
Henry Bair ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Real World ◽  
Treatment Strategies ◽  
Influential Factors ◽  
Intravitreal Ranibizumab ◽  
Multicenter Studies ◽  
Serious Adverse Events ◽  
Refractory Diabetic Macular Edema ◽  
The Mean

Introduction: To evaluate the effectiveness and safety of intravitreal dexamethasone (DEX) implants in refractory diabetic macular edema (DME) treated by intravitreal ranibizumab.Materials and Methods: We retrospectively analyzed DME patients who received DEX implant treatment after being refractory to at least 3 monthly intravitreal ranibizumab injections. The main outcomes were best-corrected visual acuity (BCVA), central retinal thickness (CRT), and intraocular pressure (IOP).Results: Twenty-nine eyes of 26 patients who had previously received an average of 8.1 ± 4.4 ranibizumab injections were included. Patients received between one and three DEX implants during 12.4 ± 7.4 months of follow-up. The mean final CRT significantly decreased from 384.4 ± 114.4 μm at baseline to 323.9 ± 77.7 μm (p = 0.0249). The mean final BCVA was 51.4 ± 21.3 letters, which was not significant compared to baseline (44.9 ± 30.2 letters, p = 0.1149). Mean IOP did not increase significantly. All patients tolerated the treatment well without serious adverse events. Higher baseline CRT and worse BCVA correlated with better therapeutic responses.Conclusion: Switching to DEX implant is feasible and safe for treating patients of DME refractory to intravitreal ranibizumab in real world. Further larger-scale or multicenter studies would be conducted to explore different DEX treatment strategies for DME, such as first-line or early switch therapy, for better BCVA improvement.

scholarly journals Comparison of Intravitreal Ranibizumab and Aflibercept for the Treatment of Diabetic Macular Edema: A Real-World Study

2021 ◽  
Author(s):  
Puren Isik ◽  
Selcuk Sizmaz ◽  
Ebru Esen ◽  
Anil Uysal ◽  
Nihal Demircan
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Real World ◽  
Treated Group ◽  
Intravitreal Ranibizumab ◽  
Significant Difference ◽  
The Mean ◽  
Retrospective Comparative Study ◽  
Change In Mean

Abstract Purpose: To compare the visual and anatomic outcomes of intravitreal ranibizumab versus aflibercept in patients with diabetic macular edema (DME) in a real-world study.Methods: This is a single-center retrospective comparative study of treatment-naïve patients who received intravitreal ranibizumab or aflibercept administration for DME for at least 12 months on an as needed regimen following three-monthly loading doses. The primary outcomes of the study were the mean change in best-corrected visual acuity (BCVA), central macular thickness (CMT), central macular volume (CMV). Factors to potentially affect these parameters were also analyzed.Results: A total of 100 eyes (66 patients) were included in the study. Fifty two eyes received ranibizumab and 48 received aflibercept injections. While the decrease in mean CMT at the 4th-month visit was significantly higher in the aflibercept-treated group than in the ranibizumab-treated group (p=0.02), there was no difference between the two groups at the end of the one-year follow-up (p=0.25). There was no significant difference between the two groups in terms of change in mean CMV during the follow-up. (p=0.26, p=0.27 at 4 and 12 months, respectively). The mean number of injections were also similar between groups (4.5 ± 1 vs. 4.6 ± 1.1 respectively, p=0.63).Conclusion: In a real-world setting, ranibizumab and aflibercept were both found to be effective in the first-line treatment of DME. Patients with DME who received fewer injections in the real-world could achieve visual and anatomical results comparable to randomized controlled trials participants.

Intravitreal Dexamethasone Implant Versus Intravitreal Ranibizumab Injection for Treatment of Non-Proliferative Diabetic Macular Edema: A Prospective, Randomized and Blinded trial

2020 ◽  
Vol 17 ◽  
Author(s):  
Sanjay Kumar Mishra ◽  
Shruti Sinha ◽  
Ravi Chauhan ◽  
Ashok Kumar
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Tertiary Care ◽  
Large Sample Size ◽  
Dexamethasone Implant ◽  
Intravitreal Ranibizumab ◽  
Intravitreal Dexamethasone Implant ◽  
The Mean ◽  
Intravitreal Dexamethasone

Introduction: In the working age population, Diabetic Macular Edema (DME) is the most common cause of visual loss. Purpose: The present study is aimed to assess the safety and efficacy of intravitreal injection of Ranibizumab (IVR) versus intravitreal Dexamethasone implant (IVD) in patients with DME in a tertiary care centre over 4 months. Methods: This is a comparative, prospective, randomized study that was done on 140 patients with macular edema confirmed on optical coherence tomography (OCT). IVD group received Ozurdex® (Allergan, Inc, Ireland) while the IVR group received Lucentis® (Novartis, Basel, Switzerland) followed up at day-1 and weeks 4, 8, 12,16. Patients were divided into Group A: patients were given 3 doses (monthly) of IVR 0.3 mg in 0.05 ml (n=70). Group B: patients given a single dose of IVD implant 0.7 mg (n=70). Results: The mean number of injections given was 1 Ozurdex® per patient Vs 3 Lucentis® per patient. The maximum reduction in central macular thickness (CMT) with IVD was 167.8 µm and 138.8µm in the 2nd and 3rd months, respectively with IVR. The Mean best-corrected visual acuity (BCVA) in the 4th month was 0.34 logMAR and 0.33 logMAR, in IVD and IVR group, respectively with consistent improvement. Patients with 0-5 letters, 6-10 letters and 10-15 letters, and >15 letters visibility in IVD group were 9.5, 20.6, 4.8, 6.4 %, and 20.4, 18.8, 20.3 20.3 % in IVR groups, respectively. The maximum intraocular pressure (IOP) rise with IVD was found to be 16 mmHg in 2 patients (3.17 %). The patients with IOP rise >10 mmHg was observed in 14/63 patients (22.22 %), the majority of patients indicated a high rise at 2nd month and all returning to baseline by 4th month. No reports of infectious endophthalmitis or new cataracts were detected in either treated groups. Conclusion: Both intravitreal Ranibizumab injection and Dexamethasone implants were found to be safe and effective in lowering CMT and improving BCVA at the 4-month follow up in patients with DME. Since there was no recurrence in CMT in the Dexamethasone implant group, we suggest that early administration before the 4th month may indicate superior efficacy over the ranibizumab injection. Further randomized trials in a large sample size with a longer period follow-up would be performed to justify the obtained results in the present study.

scholarly journals Efficacy of Intravitreal Dexamethasone Implant in Different Patterns of Diabetic Macular Edema

2020 ◽  
Author(s):  
Claudio Furino ◽  
Alfredo Niro ◽  
Michele Reibaldi ◽  
Maria Oliva Grassi ◽  
Francesco Boscia ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Serous Retinal Detachment ◽  
Intravitreal Dexamethasone Implant ◽  
The Mean ◽  
Group 2 ◽  
Intravitreal Dexamethasone ◽  
Pattern Group ◽  
Group 1

Purpose: Different patterns of diabetic macular edema (DME) suggest different pathogenesis and drug response. We evaluated the outcomes after intravitreal dexamethasone (DEX) implant for DME with or without serous retinal detachment (SRD). Methods: In this retrospective study, 22 naïve patients (23 eyes) with DME who underwent a single DEX implant were evaluated. Based on the optical coherence tomographic pattern of DME, 12 eyes had a cystoid macular edema pattern (Group 1) and 11 eyes had an SRD pattern (Group 2). The best-corrected visual acuity (BCVA), central retinal thickness (СRТ), central retinal volume (CRV), SRD height (SRDh), and intraocular pressure (IOP) were recorded before and at two and four months after the treatment. Results: There were no significant differences between the groups regarding demographic, clinical data and outcomes at baseline. In Group 1, the CRT and CRV significantly decreased at two months (P = 0.002 and P = 0.01, respectively), while the BCVA significantly improved at four months (P = 0.03). In Group 2, the CRT and CRV significantly improved (P < 0.01 and P ≤ 0.01, respectively) during the follow-up period. At four months, both groups showed a recurrence of DME, Group 1 in particular (two-month CRT reduction, –149 ± 127 μm vs four-month CRT reduction, –72 ± 174 μm; P = 0.04). The mean reduction in CRV was significantly different at four months (Group 1, –0.49 ± 1.7 mm3 vs Group 2, –1.3 ± 1.3 mm3; P = 0.04). In Group 2, the SRDh significantly decreased at two (P = 0.01) and four months (P = 0.01). Four cases with elevated IOP were managed. Conclusion: DEX implants were found to be effective in different patterns of DME. The SRD pattern may predict a longer-lasting morphologic efficacy.

scholarly journals Effect of Calcium Dobesilate (CaD) on Diabetic Macular Edema Treated by Intravitreal Ranibizumab

2021 ◽  
Author(s):  
Dongxuan Wang ◽  
Hui Wang ◽  
Shuang Wu ◽  
Xueqiu Yang ◽  
Jiansen Xu
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Calcium Dobesilate ◽  
Intravitreal Ranibizumab ◽  
Corrected Visual Acuity ◽  
The Mean ◽  
Pro Re Nata ◽  
Dose Injection ◽  
Control Study

Abstract Background: Calcium dobesilate (CaD) had been used in the treatment of diabetic retinopathy (DR) due to its potential in protecting against retinal vascular damage. However, it did not reduce the risk of development of diabetic macular edema (DME). The aim of this study was to investigate the effect of CaD plus intravitreal ranibizumab in the treatment of DME.Methods: This retrospective, observational, consecutive case control study enrolled patients newly diagnosed with DME who received intravitreal ranibizumab (IVR) administration with 3-monthly loading dose injection followed by pro re nata (3+PRN) regimen with or without CaD orally daily for at least 12-month follow-up. Medical records and optical coherence tomography (OCT) results were reviewed and compared at baseline and at 3, 6, and 12 months after injection.Results: A total of 102 eyes from 102 patients were enrolled in this study. Fifty-four patients received IVR combined with CaD orally (IVR+CaD group), while forty-eight patients received IVR solely (IVR group). No statistically significant differences were found in the general condition of patients between the two groups at baseline (P > 0.05). At every follow-up, 3, 6 and 12 months after injection, the best corrected visual acuity (BCVA) improved and the central macular thickness (CMT) decreased in both groups when compared with those at baseline (P < 0.05), while there were no significant differences in BCVA improvement and CMT reduction between the two groups (P > 0.05). The mean number of ranibizumab injections in R+C group was significantly lower than that in R group (5.4 ± 1.1 injections versus 6.7 ± 1.6 injections, P<0.05) within 1-year treatment. No adverse events were found in neither groups.Conclusions: Adding oral CaD to intravitreal ranibizumab was demonstrated to have similar effectiveness and safety for improving visual function and restoring the anatomy of the retina in macular with fewer injections in DME patients.

scholarly journals Real-World Treatment Patterns and Vision Outcomes with Ranibizumab for Diabetic Macular Edema

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Tadas Naujokaitis ◽  
Vilma Jurate Balciuniene
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Real World ◽  
Clinical Setting ◽  
Retrospective Chart Review ◽  
First Year ◽  
Intravitreal Ranibizumab ◽  
Second Year ◽  
Gain Loss

Purpose. To assess injection patterns and vision outcomes in patients receiving intravitreal ranibizumab injections for diabetic macular edema in a real-world clinical setting. Methods. Retrospective chart review involving 74 eyes of 62 patients who started ranibizumab treatment for diabetic macular edema at the Hospital of the Lithuanian University of Health Sciences Kauno Klinikos. Data collected included follow-up visits, injections administered, and best-corrected visual acuity (BCVA). Results. Median follow-up duration was 652.5 days (min 365; max 914). Over the first year, eyes received a median of 4 injections (min 1; max 10). Among eyes with 2-year follow-up and injections during the second year, there was a median of 3 injections (min 1; max 6) over the second year. The BCVA improved by a median of 5 letters 365 ± 60 days and 730 ± 60 days after baseline. At the first visit ≥365 days after baseline, 13.5% of eyes gained ≥15 letters from baseline while 6.8% of eyes lost ≥15 letters. For 74.3% of eyes, BCVA improved (gain of ≥5 letters) or remained stable (gain/loss of ≤4 letters). Conclusion. Intravitreal ranibizumab for diabetic macular edema was effective in a real-world clinical setting, with most eyes gaining or maintaining vision. Compared with randomized prospective clinical trials, patients received less frequent injections and achieved lower vision gains.

scholarly journals Switching to Aflibercept in Diabetic Macular Edema Not Responding to Ranibizumab and/or Intravitreal Dexamethasone Implant

2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Antoine Herbaut ◽  
Franck Fajnkuchen ◽  
Lise Qu-Knafo ◽  
Sylvia Nghiem-Buffet ◽  
Bahram Bodaghi ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Retinal Thickness ◽  
Dexamethasone Implant ◽  
Short Term ◽  
Intravitreal Dexamethasone Implant ◽  
Refractory Diabetic Macular Edema ◽  
The Mean ◽  
Intravitreal Dexamethasone ◽  
Anatomical Outcomes

Purpose. To assess short-term functional and anatomical outcomes of refractory diabetic macular edema (DME) following a switch from ranibizumab or dexamethasone to aflibercept. Methods. We included retrospectively eyes with persistent DME after at least 3 ranibizumab and/or one dexamethasone implant intravitreal injections (IVI). The primary endpoint was the mean change in visual acuity (VA) at month 6 (M6) after switching. Results. Twenty-five eyes were included. Before switching to aflibercept, 23 eyes received a median of 9.5 ranibizumab, and among them, 6 eyes received one dexamethasone implant after ranibizumab and 2 eyes received only one dexamethasone implant. Baseline VA, before any IVI, was 52.9 ± 16.5 letters, and preswitch VA was 57.1 ± 19.6 letters. The mean VA gain was +8 letters (p=0.01) between preswitch and M6. The mean central retinal thickness was 470.8 ± 129.9 μm before the switch and 303.3 ± 59.1 μm at M6 (p=0.001). Conclusion. Switching to aflibercept in refractory DME results in significant functional and anatomical improvement. The study was approved by the France Macula Federation ethical committee (FMF 2017-138).

scholarly journals Effectiveness of Intravitreal Ranibizumab in Nonvitrectomized and Vitrectomized Eyes with Diabetic Macular Edema: A Two-Year Retrospective Analysis

2020 ◽  
Vol 2020 ◽  
pp. 1-8
Author(s):  
Ozgun Melike Gedar Totuk ◽  
Ayse Yagmur Kanra ◽  
Mohammed Nadim Bromand ◽  
Guler Kilic Tezanlayan ◽  
Sevil Ari Yaylalı ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Medical Records ◽  
Response To Treatment ◽  
Intravitreal Ranibizumab ◽  
Female Ratio ◽  
Corrected Visual Acuity ◽  
The Mean ◽  
Male To Female

The aim of this study was to compare the effectiveness of intravitreal ranibizumab (IVR) injections for the treatment of diabetic macular edema (DME) in eyes with and without previous vitrectomy. The medical records of 28 eyes (11 vitrectomized and 17 nonvitrectomized) of 28 patients (mean age, 59.0 ± 9.6 years; male to female ratio 1 : 1) who were diagnosed with DME and had received IVR treatment were reviewed retrospectively. The indications of vitrectomy in 11 vitrectomized eyes were intravitreal hemorrhage (n = 8) and epiretinal membrane (n = 3). The best-corrected visual acuity (BCVA), central macular thickness (CMT), and total macular volume (TMV) were measured at baseline and at months 6, 12, 18, and 24 of the follow-up. The number of IVR injections, the duration between diagnosis of DME and IVR injection, and the hemoglobin A1c (HbA1c) level at baseline were also recorded. Baseline demographics, HbA1c, BCVA, CMT, and TMV values were similar between two groups (p>0.05). The duration between diagnosis of DME and IVR injections was similar in both groups (16 ± 5 months vs. 13 ± 4 months, respectively; p=0.11). IVR injection was performed 6.3 times in vitrectomized eyes and 6.1 times in nonvitrectomized eyes during the 24-month period (p>0.05). The mean BCVA improved significantly during the 24-month period in both groups. The improvements in BCVA, in CMT, and in TMV were more significant at month 6 (p=0.036) group, at month 12 (p=0.013), at month 12 (p=0.021), and month 24 (p=0.021) in nonvitrectomized eyes, respectively, while there was no difference in improvements of BCVA, CMT, and TMV in vitrectomized group at each visit. Treatment effected by time in terms of BCVA, CMT, and TMV values in all groups (p=0.0004, p<0.0001, p<0.0001, respectively), not by time-group interaction and group (all p values >0.05). In conclusion, IVR treatment for DME is equally effective in both groups. However, the response to treatment is seen earlier in nonvitrectomized eyes compared to vitrectomized eyes.

scholarly journals Effectiveness of Intravitreal Ranibizumab in Nonvitrectomized and Vitrectomized Eyes with Diabetic Macular Edema: A Two-Year Retrospective Analysis

2019 ◽  
Author(s):  
Ozgun Melike Gedar Totuk ◽  
Ayse Yagmur Kanra ◽  
Mohammed Nadim Bromand ◽  
Guler Kilic ◽  
Sevil Ari Yaylali ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Response To Treatment ◽  
Intravitreal Ranibizumab ◽  
Female Ratio ◽  
Corrected Visual Acuity ◽  
Baseline Values ◽  
The Mean ◽  
Male To Female

Abstract Background: To compare the effectiveness of intravitreal ranibizumab (IVR) injections for the treatment of diabetic macular edema (DME) in eyes with and without previous vitrectomy. Methods: The medical records of 30 eyes (13 vitrectomized, 17 nonvitrectomized) of 28 patients (mean age, 59.0±9.6 years; male to female ratio 1:1) who were diagnosed with DME and had received IVR treatment were reviewed retrospectively. The indications of vitrectomy in 13 vitrectomized eyes were intravitreal hemorrhage (n=8), vitreomacular traction (n=1), and epiretinal membrane (n=4). The best-corrected visual acuity (BCVA), central macular thickness (CMT), and total macular volume (TMV) were measured at baseline and at months 6, 12, 18, and 24 of the follow-up. The number of IVR injections, the duration between diagnosis of DME and IVR injection, and hemoglobin A1c ( HbA1c ) level at baseline were also recorded. Retreatment criteria included persistence of submacular fluid, intraretinal cysts, or CMT of more than 300 μm. Results: Baseline demographics, HbA1c, BCVA, CMT, and TMV values were similar between the vitrectomized and nonvitrectomized groups (p>0.05). The duration between diagnosis of DME and IVR injections was longer in the nonvitrectomized group than in the vitrectomized group (16±5 months vs. 13±4 months, respectively; p=0.045). IVR injection was performed 6.3 times in vitrectomized eyes and 6.1 times in nonvitrectomized eyes during the 24-month period (p>0.05). The mean BCVA improved significantly during the 24-month period in both groups (for vitrectomized group from 0.51±0.26 logMAR to 0.40±0.22 logMAR; for nonvitrectomized group from 0.72±0.28 logMAR to 0.50±0.22 logMAR). The improvement in BCVA was significant at month 6 in nonvitrectomized eyes, while there was no significant improvement in vitrectomized eyes before month 18. Compared to the baseline values, the decrease in both CMT and TMV was significant in months 6, 12, 18, and 24 in the nonvitrectomized group (p<0.05). In the vitrectomized group both CMT and TMV improved significantly only in months 18 and 24 (p<0.05). Conclusion: IVR treatment for DME is equally effective in both vitrectomized and nonvitrectomized eyes. However, the response to treatment is seen later in vitrectomized eyes compared to nonvitrectomized eyes.

scholarly journals Efficacy and Safety of a Dexamethasone Implant in Patients with Diabetic Macular Edema at Tertiary Centers in Korea

2016 ◽  
Vol 2016 ◽  
pp. 1-9 ◽  
Author(s):  
Byung Gil Moon ◽  
Joo Yong Lee ◽  
Hyeong Gon Yu ◽  
Ji Hun Song ◽  
Young-Hoon Park ◽  
...  
Keyword(s):  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Subretinal Fluid ◽  
Additional Treatment ◽  
Dexamethasone Implant ◽  
Efficacy And Safety ◽  
Diffuse Type ◽  
The Mean ◽  
Intravitreal Dexamethasone

Purpose. To evaluate the real-world efficacy and safety of the dexamethasone implant (DEX implant) in patients with diabetic macular edema (DME). Methods. Retrospective, multicenter, and noncomparative study of DME patients who were treated with at least one DEX implant. A total of 186 eyes from 165 patients were included. Best-corrected visual acuity (BCVA), central retinal thickness (CRT), complications, and number of retreatments were collected. Data at baseline and monthly for 6 months were analyzed. Results. The average baseline BCVA and CRT were 0.60 LogMAR and 491.6 μm, respectively. The mean BCVA improved until 3 months and then decreased up to 6 months of follow-up (0.53, 0.49, and 0.55 LogMAR at 1, 3, and 6 months; p=0.001, <0.001, and 0.044, resp.). The change of mean CRT was similar to BCVA (345.0, 357.7, and 412.5 μm at 1, 3, and 6 months, p<0.001, <0.001, and <0.001, resp.). 91 eyes (48.9%) received additional treatment with anti-VEGF or DEX implant. The average treatment-free interval was 4.4 months. In group analyses, the DEX implant was more effective in pseudophakic eyes, DME with subretinal fluid (SRF), or diffuse type. Conclusions. Intravitreal dexamethasone implants are an effective treatment for patients with DME, most notably in pseudophakic eyes, DME with SRF, or diffuse type. A half of these patients require additional treatment within 6 months.

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