scholarly journals Correlation between improvement in visual acuity and QOL after Ranibizumab treatment for age-related macular degeneration patients: QUATRO study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yuji Oshima ◽  
Yumi Ishibashi ◽  
Naoyasu Umeda ◽  
Tatsuo Nagata ◽  
Shigeo Yoshida ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Visual Function ◽  
Age Related Macular Degeneration ◽  
Open Label ◽  
Intravitreal Ranibizumab ◽  
Satisfaction Questionnaire ◽  
Age Related ◽  
The Mean ◽  
Baseline Visual Acuity ◽  
Ranibizumab Treatment

Abstract Background To evaluate the correlation between visual acuity improvement and vision-related QOL after ranibizumab treatment in Japanese patients with AMD. Methods In this one-year prospective, interventional, open-label, multicenter study involving four sites, patients with neovascular AMD were enrolled and observed for 12 months. Treatment-naïve patients received 0.5 mg ranibizumab as needed after three initial monthly doses. The best corrected visual acuity (BCVA) and central macular thickness (CMT) were measured at every visit. Evaluations with the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and patient satisfaction questionnaire were performed at baseline and 3 and 12 months after initial treatment. The primary endpoint was change in BCVA and QOL 3 months after ranibizumab treatment. QOL outcomes were also assessed in the better and poor BVCA subgroups. Results The study enrolled 100 patients. The mean logMAR BCVA after treatment improved significantly from 0.43 to 0.30 at 3 months (p< 0.0001), and 0.28 at 12 months (p< 0.0001). The mean NEI-VFQ-25 composite scores improved from 79.48 to 84.13 at 3 months (p< 0.0001), and 86.0 at 12 months (p< 0.0001). The 3 and 12-month changes in NEI-VFQ-25 score and BCVA showed significant correlation. In the poor baseline visual acuity group (decimal BCVA ≤0.5), there was a significant correlation between the changes in the NEI-VFQ-25 score and BCVA (p=0.02) but not in the better baseline visual acuity group (decimal BCVA > 0.6, p=0.1) at 3 months. There were no significant differences in the satisfaction questionnaire score from baseline to at 3 months (p=0.54) and 12 months (p=0.23). The average CMT improved significantly from 340 to 264 μm at 3 months (p< 0.0001) and to 268 μm at 12 months (p< 0.0001). Conclusions Intravitreal ranibizumab treatment resulted in improvement in visual acuity, anatomical change, and visual function change in Japanese AMD patients. Significant improvement was seen in patient visual function, and this was correlated with changes in VA, except immediately after loading dose treatment in patients with higher baseline VA. The patients’ satisfaction with the treatment remained unchanged during the study period. Trial registration This study is registered at UMIN Clinical Trials Registry (UMIN000012013). Registered October 10, 2013, as prospective study.

scholarly journals Correlation Between Improvement in Visual Acuity and QOL After Ranibizumab Treatment for Age-related Macular Degeneration Patients: QUATRO Study

2020 ◽  
Author(s):  
Yuji Oshima ◽  
Yumi Ishibashi ◽  
Naoyasu Umeda ◽  
Tatsuo Nagata ◽  
Shigeo Yoshida ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Patient Satisfaction ◽  
Visual Function ◽  
Age Related Macular Degeneration ◽  
Open Label ◽  
Satisfaction Questionnaire ◽  
Age Related ◽  
The Mean ◽  
Baseline Visual Acuity ◽  
Ranibizumab Treatment

Abstract Background: To evaluate the correlation between visual acuity improvement and vision-related QOL after ranibizumab treatment in Japanese patients with AMD.Methods: In this one-year prospective, interventional, open-label, multicenter study involving four sites, patients with neovascular AMD were enrolled and observed for 12 months. Treatment-naïve patients received 0.5 mg ranibizumab as needed (PRN) after three initial monthly doses. The best corrected visual acuity (BCVA) and central macular thickness (CMT) were measured at every visit. Fluorescein and indocyanine green angiography, and evaluations with the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and patient satisfaction questionnaire were performed at baseline and 3 and 12 months after initial treatment. The primary endpoint was the change in BCVA and QOL 3 months after ranibizumab treatment. Secondary endpoints included change in BCVA, QOL, CMT, and patient satisfaction over 12 months.Results: The study enrolled 100 patients. The mean logMAR BCVA after the 3-month treatment improved significantly from 0.43 to 0.30 (p<0.0001). The mean NEI-VFQ-25 composite scores were higher after 3 months of ranibizumab treatment, improving from 79.48 to 84.13 (p<0.0001). The changes in the NEI-VFQ-25 score and BCVA showed significant correlation in the poor baseline visual acuity group (decimal BCVA below 0.5, p=0.02) but not in the better baseline visual acuity group (decimal BCVA above 0.6, p=0.1) after the three loading doses. There were no significant differences in the satisfaction questionnaire score from baseline to after the three loading doses (p=0.5466). The average CMT improved significantly from 340 to 264 mm after the loading doses (p<0.0001).Conclusions: Intravitreal ranibizumab treatment resulted in improvement in visual acuity, anatomical change, and visual function change in Japanese AMD patients. Significant improvement was seen in patient visual function, but this was not correlated with changes in VA in patients with higher or lower baseline VA. The patients' satisfaction with the treatment remained unchanged during the study period.

Intravitreal Ranibizumab for Patients with Neovascular Age-Related Macular Degeneration with Good Baseline Visual Acuity

2014 ◽  
Vol 233 (1) ◽  
pp. 27-34 ◽  
Author(s):  
Aki Kato ◽  
Tsutomu Yasukawa ◽  
Keiji Suga ◽  
Yoshio Hirano ◽  
Miho Nozaki ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Morphological Changes ◽  
Primary Treatment ◽  
Additional Treatment ◽  
Age Related Macular Degeneration ◽  
Intravitreal Ranibizumab ◽  
Age Related ◽  
The Mean ◽  
Baseline Visual Acuity

Purpose: To report the 1-year results of intravitreal ranibizumab (IVR) injections for neovascular age-related macular degeneration (nAMD) in patients with good baseline visual acuity (VA). Methods: Thirty-six eyes of 36 patients with nAMD with best-corrected VAs (BCVAs) >0.6 (equal to 0.22 in the logarithm of the minimum angle of resolution unit) were enrolled. IVR was the primary treatment; additional treatment was administered as needed. BCVAs and central retinal thickness (CRT) were measured periodically. Results: The mean number of injections at month 12 was 3.3. The mean BCVAs were 0.11 ± 0.02 at baseline and 0.12 ± 0.03 at month 12, which did not significantly differ. The mean CRT significantly improved from 320 ± 15 to 254 ± 12 μm at month 12 (p < 0.01). Photodynamic therapy was applied in 2 cases because of frequent recurrences. Conclusions: IVR maintained VA and improved morphological changes in wet AMD with good baseline VA.

scholarly journals Ranibizumab in Macular Edema Secondary to Branch Retinal Vein Occlusion – 24 Months Of Treatment

2019 ◽  
Vol 75 (4) ◽  
pp. 190-198
Author(s):  
Markéta Středová ◽  
Alexandr Stepanov ◽  
Jan Studnička ◽  
Jana Nekolová ◽  
Naďa Jirásková
Keyword(s):  
Visual Acuity ◽  
Macular Edema ◽  
Intravitreal Ranibizumab ◽  
Duration Of Symptoms ◽  
Younger Patients ◽  
Vein Occlusion ◽  
The Mean ◽  
Common Clinical Practice ◽  
Baseline Visual Acuity ◽  
Ranibizumab Treatment

Purpose: To retrospectively evaluate the efficacy and safety of ranibizumab treatment for macular edema (ME) secondary to branch retina vein occlusion (BRVO) after 24 months. Materials and Methods: 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 544,9 μm. At 64,1% patients a retinal 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, a statistically 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 < 0,001), at 6 months 12,5 letters (p < 0,001), at 9 months 10,5 letters (p < 0,001), at 12 months 12,5 (p < 0,001), at 24 months 8,6 letters (p < 0,05). There was a statistically significant decrease in CRT as well in the 3, 6, 9, 12 and 24 months visits, namely 249,0 μm (p < 0,001), 185,2 μm (p < 0,001), 187,0 μm (p < 0,001), 214,8 μm (p < 0,001) and 205,2 μm (p < 0,001). The average number of doses administered to a patient was 4,9 within 12 months and 7,1 within 24 months. The treatment had greater effect in younger patients with shorter duration of symptoms and baseline VA of less than 55 ETDRS letters (6/24 or worse. Nor serious, neighter long-term adverse events occured, only occasional intraocular pressure elevation after intravitreal application was found. Conclusion: Our results from common clinical practice are consistent with the results of large clinial trials, we confirmed particularly good treatment efficacy in younger patients with shorter duration of macular edema and poorer baseline visual acuity. The safety of ranibizumab treatment was confirmed.

scholarly journals Safety and tolerability of ranibizumab in uni/bilateral neovascular age-related macular degeneration: 12-month TWEYEs study

2019 ◽  
Vol 104 (1) ◽  
pp. 64-73
Author(s):  
Francesco Bandello ◽  
Giovanni Staurenghi ◽  
Federico Ricci ◽  
Edoardo Midena ◽  
Francesco Viola ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
Age Related Macular Degeneration ◽  
Open Label ◽  
Age Related ◽  
Risk Period ◽  
The Mean ◽  
Low Incidence ◽  
To Receive ◽  
Systemic Drug

BackgroundTo evaluate the safety and tolerability of ranibizumab 0.5 mg in patients with uni/bilateral neovascular age-related macular degeneration (nAMD) and best-corrected visual acuity (BCVA)<2/10 and/or second eye affected, regardless of BCVA.MethodsIn this 12-month, prospective, multicentre, open-label, single arm, pragmatic interventional study, patients (N=941) aged ≥ 50 years were to receive ranibizumab as per approved label, monthly until maximum stable visual acuity (VA) was achieved (initially, three or more injections may be required). Thereafter, patients were to be monitored monthly for VA and treatment was to be resumed if VA was reduced due to disease activity.ResultsOf the 936 patients treated with ranibizumab at least once during the study, 823/113 were unilaterally/bilaterally (not simultaneously) treated . The mean (SD) number of ranibizumab injections during the study was 5.4 (2.9)/10.6 (5.0) injections in uni/bilaterally treated patients. Three systemic drug-related adverse events (AEs) (all serious, all in unilaterally treated patients) and 18 systemic AE of special interest (AESIs) (11 serious, 16/2 in unilaterally/bilaterally treated patients) occurred during the study. The annual incidence rate (AIR) (events/1000 person-years) for systemic drug-related AEs, considering a 15-day/30-day risk period, 11.0/8.5 for unilaterally treated patients. Considering the same risk period, the AIR (events/1000 person-years) for systemic AESIs for unilaterally treated patients was 22.1/19.9. Considering a 30-day risk period, the AIR (events/1000 treated eye-years) of ocular drug-related AEs was 23 and AESIs was 11.5.ConclusionsThe low incidence of AEs and AESIs demonstrated the good safety and tolerability of ranibizumab in unilaterally/bilaterally treated patients with nAMD in this real-world setting.

scholarly journals High frequency SD-OCT follow-up leading to up to biweekly intravitreal ranibizumab treatment in neovascular age-related macular degeneration

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Cengiz Tuerksever ◽  
Christian Pruente ◽  
Katja Hatz
Keyword(s):  
Visual Acuity ◽  
Macular Degeneration ◽  
High Frequency ◽  
Subretinal Fluid ◽  
Age Related Macular Degeneration ◽  
Intravitreal Ranibizumab ◽  
Age Related ◽  
Ranibizumab Treatment ◽  
Sd Oct

AbstractA remarkable proportion of neovascular age-related macular degeneration (nAMD) patients respond rather poorly to ranibizumab treatment, in spite of the minimum 4-week follow-up and treatment interval. Usually, retreatments are based on nAMD activity as evaluated by Spectral-domain Optical coherence Tomography (SD-OCT), biomicroscopic fundus examination and visual acuity changes. In this prospective pilot study, we aimed to study SD-OCT changes in a high-frequent follow-up manner (weekly (month 0–6), biweekly (month 7–12)) throughout the first year, which consequently led to intravitreal ranibizumab being administered up to biweekly. Best corrected visual acuity (BCVA) was already significantly improved at week 2. Central retinal thickness (CRT), intraretinal and subretinal fluid (SRF) were significantly improved from week 1 onwards. Half of the patients showed nAMD activity at week 2 or 3 and received the first retreatment earlier than 4 weeks after baseline injection. In total, 46% of retreatments were already applied 2 or 3 weeks after the previous treatment. Greater range of CRT and SRF fluctuation during follow-up was associated with lower final BCVA. Lower baseline BCVA and better SRF improvement at week 2 was associated with greater BCVA improvement. In conclusion, high-frequency SD-OCT follow-up provided a good option for adapting treatment in nAMD individually.

scholarly journals Long-term Efficacy of a Treat-and-Extend Regimen With Ranibizumab in Patients With Neovascular Age-Related Macular Disease: An Open-label 12-month Extension to the CANTREAT Study

2021 ◽  
Author(s):  
Peter J. Kertes ◽  
Tom Sheidow ◽  
Geoff Williams ◽  
Mark Greve ◽  
Ivan J. Galic ◽  
...  
Keyword(s):  
Age Related Macular Degeneration ◽  
Vascular Endothelial ◽  
Open Label ◽  
Intravitreal Ranibizumab ◽  
Macular Disease ◽  
Treat And Extend ◽  
Age Related ◽  
The Mean ◽  
Endothelial Growth Factor

Introduction: To assess the long-term effectiveness of a treat-and-extend (T&E) anti-vascular endothelial growth factor regimen in patients with neovascular age-related macular degeneration who remain on T&E and those switched from once-monthly (OM) dosing to T&E (OM-T&E). Methods: In this 12-month extension of the 2-year CANTREAT study, patients received intravitreal ranibizumab 0.5 mg in a T&E regimen. Main outcome measures included mean change in best-corrected visual acuity (BCVA) from baseline and from month 24 to month 36; percentages of patients who gained ≥5, ≥10, or ≥15 Early Treatment of Diabetic Retinopathy Study (ETDRS) letters or lost ≥5, ≥10, or ≥15 letters from baseline and from month 24 to month 36; and number of injections administered from baseline and from month 24 to month 36 for both groups. Results: Of the 139 patients (73 T&E, 66 OM-T&E) in the extension, 121 (68 T&E, 53 OM-T&E) completed 36 months. Mean (standard deviation [SD]) BCVA changes from baseline to the extension last visit (month 33-36) were +6.6 (11.4) letters in the T&E group and +4.8 (14.3) letters in the OM-T&E group, representing maintenance of 24-month gains. The mean (SD) numbers of injections during the extension were 7.3 (2.7) for T&E and 7.1 (2.8) for OM-T&E. Discussion/Conclusion: These findings suggest that after 36 months of treatment, the mean BCVA improvement achieved at 24 months is maintained for both the patients exclusively treated with the T&E regimen and those that switched to T&E after 24 months in the OM regimen.

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