Ranibizumab for the Treatment of Diabetic Macular Oedema in the Real-World Clinical Setting in Portugal: A Multicentre Study

Farinha, Cláudia; Martins, Amélia; Neves, A.; Soares, Raquel; Ruão, Miguel; Ornelas, Mário; Neves, Pedro; Rodrigues, Filipa Gomes; Coelho, Constança; Silva, Rufino

doi:10.1159/000489046

Cited by 9 publications

(10 citation statements)

References 22 publications

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“…Several real-world studies on ranibizumab in DME have evaluated treatment patterns and outcomes over periods of 9 to 24 months. [22][23][24][25][26][27][28][29][30][31][32][33][34][35] Mean number of ranibizumab injections ranged from 3.1 to 7.2. VA gains varied between +0.0 and +8.4 letters with CRT reductions ranging from −83.9 µm to −164.6 µm.…”

Section: Discussionmentioning

confidence: 99%

<p>Real-World Outcomes in Patients with Diabetic Macular Edema Treated Long Term with Ranibizumab (VISION Study)</p>

Aken¹,

Favreau²,

Ramboer³

et al. 2020

OPTH

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Aim Evaluate long-term real-world treatment patterns and associated effectiveness and safety outcomes in patients with diabetic macular edema (DME) treated ≥36 months with 0.5mg ranibizumab. Methods Open-label observational effectiveness study in 9 Belgian clinics. Included were primary treated eyes of 55 DME patients between August 2014 and March 2015 and followed for 3.5±1.8 years. Eyes were 21.8% treatment (TX)-naïve, 9.1% non-naïve with exclusive prior anti-VEGF treatment (PRIOR-anti-VEGF), and 63.6% non-naïve with other prior treatments (PRIOR-other). Intravitreal injections with ranibizumab were administered per ophthalmologists’ best clinical judgment. Trend testing of changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) over time occurred using mixed regression analysis. Results The mean±SD number of treatments in the first year was 5.1±3.0 (TX-naïve), 4.5±2.7 (PRIOR-anti-VEGF) and 5.6±3.1 (PRIOR-other). At 12 months, BCVA increased by 8.9±16.4 letters from 59.7±9.3 at baseline in TX-naïve (p<0.0001), by 11.8±9.9 from 61.6±8.5 in PRIOR-anti-VEGF (p=0.03), and by 4.2±10.6 from 58.2±14.6 in PRIOR-other groups (p=0.0002). BCVA remained stable for the remainder of follow-up in all groups. CRT decreased over the first 2 months by monthly rates of −43.8µm in TX-naïve (p=0.04), −75.7µm in PRIOR-anti-VEGF (p=0.02), and −65.8µm in PRIOR-other eyes (p=0.0003), showing stability afterwards. No unknown adverse events were recorded; a painful eye following injection was registered with a possible relationship to the treatment. Conclusion This real-world study confirms the effectiveness of ranibizumab in preventing a decline in BCVA and demonstrated initial improvement and subsequent retention of BCVA in DME patients ≥36 months. Ranibizumab initially reduced and then maintained CRT. However, these data reveal that treatment intensity and BCVA and CRT outcomes are lower than those found in early efficacy trials. Under-treatment likely accounts for this efficacy-effectiveness gap. Yet, intravitreal ranibizumab is an effective and safe long-term treatment for DME under conditions of significant heterogeneity in patients and treatment patterns.

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Section: Discussionmentioning

confidence: 99%

<p>Real-World Outcomes in Patients with Diabetic Macular Edema Treated Long Term with Ranibizumab (VISION Study)</p>

Aken¹,

Favreau²,

Ramboer³

et al. 2020

OPTH

View full text Add to dashboard Cite

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“…On the contrary, poor baseline visual acuity is predictive of a larger increase in vision [9]. For similar reasons, lower baseline CMT (thinner macula) has been shown to have superior anatomical outcomes but smaller overall reduction in CMT [10][11][12][13]. A growing number of studies today have attempted to use spectral domain optical coherence tomography based (SD-OCT based) imaging biomarkers for diagnosis, monitoring and treatment-prediction of DME.…”

Section: Introductionmentioning

confidence: 99%

Predictive factors for treatment outcomes with intravitreal anti-vascular endothelial growth factor injections in diabetic macular edema in clinical practice

et al. 2023

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Background Intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections are the standard of care for diabetic macular edema (DME), a common complication of diabetes. This study aimed to identify factors influencing DME intravitreal anti-VEGF treatment outcomes in real-world practice. Methods This was a multi-center retrospective observational study using medical chart review of participants receiving anti-VEGF injections for DME (N = 248). Demographic and clinical variables were assessed for association with best corrected visual acuity (BCVA) and central macular thickness (CMT) outcomes using regression models. Results There was a significant improvement in BCVA (p < 0.001) and CMT (p < 0.001) after 12 months of treatment, although 21% of participants had decreased BCVA, and 41% had a < 10% CMT reduction at 12 months. Higher baseline BCVA (p = 0.022, OR=-0.024, 95% CI=-0.046,-0.004) and longer duration of diabetic retinopathy (p = 0.048, OR=-0.064, 95% CI=-0.129,-0.001) were negative predictors for BCVA response, whereas Aflibercept treatment (p = 0.017, OR = 1.107, 95% CI = 0.220,2.051) compared with other drugs and a positive “early functional response” (p < 0.001, OR=-1.393, 95% CI=-1.946,-0.857) were positive predictors. A higher baseline CMT (p < 0.001, OR = 0.019, 95% CI = 0.012,0.0261) and an “early anatomical response”, (p < 0.001, OR=-1.677, 95% CI=-2.456, -0.943) were predictors for greater reduction in CMT. Overall, the variables could predict only 23% of BCVA and 52% of CMT response. Conclusions The study shows a significant proportion of DME patients do not respond to anti-VEGF therapy and identifies several clinical predictors for treatment outcomes. Trial registration The study was approved through the Human Research Ethics Committee, University of Tasmania (approval number H0012902), and the Southern Adelaide Clinical Human Research Ethics Committee (approval number 86 − 067).

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“…Nevertheless, based on limited accessibility to health-care services, poor systemic conditions, and/or nonadherence to the treatment by patients, individualized treatment regimen varies substantially in clinical practice, mostly resulting in less frequent injections and less clinic visits than those recommended by strictly monitored clinical trials [16][17][18][19]. Then, the less favorable outcomes following anti-VEGF therapy for DME in clinical practice have been a concern [20][21][22][23][24]. Therefore, assessing the long-term benefit of intravitreal anti-VEGF therapy for DME in real clinical practice may add more valuable information for treatment decisions.…”

Section: Introductionmentioning

confidence: 99%

Intravitreal Anti-Vascular Endothelial Growth Factor Therapy for Diabetic Macular Edema in Clinical Practice of Single Center: Three-Year Outcomes

et al. 2020

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Introduction: To explore visual and anatomical outcomes in patients who underwent intravitreal anti-vascular endothelial growth factor injection for visual impairment from center-involved diabetic macular edema (CI-DME) in clinical practice. Methods: Medical records of consecutive CI-DME patients who initiated treatment with intravitreal bevacizumab injection between Jan 2012 and Dec 2016 and were followed for at least 12 months were retrospectively reviewed. Visual and anatomical changes after treatment over a 36-month period were evaluated. Results: There were 286 patients (423 eyes) with a mean (SD) age of 56.8 (8.5) years included in this study. One hundred and forty-six (51%) patients were female and 137 (47.9%) patients received bilateral-eye treatment. Mean (SD) presenting visual acuity (VA) of overall eyes was 50.2 (19.6) letter scores. Stratified by baseline vision, eyes with initial VA worse than 20/40 achieved a statistically significant VA improvement, compared to baseline, by +8.4, +6.9, and +5.4 letters at 12, 24, and 36 months, respectively with all p values < 0.001. However, when initial VA was 20/40 and better, a non-statistically significant change in mean VA by +2.0, -3.5, and -3.6 letters were noted at the same time-point (p value between 0.078 to 0.273). Unlike visual changes, a statistically significant decline in central subfield thickness compared to baseline was noted at the end of month 12, 24, and 36 in both initial VA subgroups (all p values < 0.001). Nevertheless, even though the median number of given injections considerably decreased from 6 in the first 12 months to 2 in the second 12-month period and 1 in the final 12-month interval. Required ophthalmic clinic visits decreased in frequency with median numbers of 10, 7 and 6 appointments in each consecutive 12-month duration. Conclusion: This study supports the benefits of practical intravitreal anti-VEGF utilization to manage CI-DME in real-world settings. The improvement of vision in eyes presenting with poor baseline VA and a maintenance of vision in eyes with better baseline VA were demonstrated through the 3-year review of each case. However, the burden of frequent monitoring warrants further evaluation of long-term compliance and efficacy.

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Ranibizumab for the Treatment of Diabetic Macular Oedema in the Real-World Clinical Setting in Portugal: A Multicentre Study

Cited by 9 publications

References 22 publications

<p>Real-World Outcomes in Patients with Diabetic Macular Edema Treated Long Term with Ranibizumab (VISION Study)</p>

<p>Real-World Outcomes in Patients with Diabetic Macular Edema Treated Long Term with Ranibizumab (VISION Study)</p>

Predictive factors for treatment outcomes with intravitreal anti-vascular endothelial growth factor injections in diabetic macular edema in clinical practice

Intravitreal Anti-Vascular Endothelial Growth Factor Therapy for Diabetic Macular Edema in Clinical Practice of Single Center: Three-Year Outcomes

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