Effectiveness and safety of ranibizumab 0.5 mg in treatment-naïve patients with diabetic macular edema: Results from the real-world global LUMINOUS study

Mitchell, Paul; Sheidow, Tom; Farah, Michel Eid; Mahmood, Sajjad; Minnella, Angelo Maria; Eter, Nicole; Eldem, Bora; Al-Dhibi, Hassan; Macfadden, Wayne; Parikh, Soumil; Dunger-Baldauf, Cornelia; Mahgoub, Mohamed M; Schmidt‐Erfurth, Ursula

doi:10.1371/journal.pone.0233595

Cited by 45 publications

(50 citation statements)

References 23 publications

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“…We noted that the frequency of IVI in our patients before the pandemic, with a mean of 2 injections per 6 months, was within the expected range demonstrated in real-life surveys, 23,24 including a particular subgroup of patients, comprising about 12% in our cohort, who show modest or poor response to therapy and need monthly or near monthly injections. Unfortunately, due to the lockdown, our patients' IVI therapy was deferred until further notice.…”

Section: Discussionsupporting

confidence: 78%

Clinical Experience in the Administration of Intravitreal Injection Therapy at a Tertiary University Hospital in Jordan During the COVID-19 Lockdown

Saleh¹,

Jammal²,

Alqudah³

et al. 2020

OPTH

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Purpose: To describe the clinical experience with the delivery of intravitreal injection therapy to patients with various indications at a tertiary university hospital during the COVID-19 lockdown in Jordan. Methods: This is a retrospective observational study of patients who received intravitreal injections between April 12th and May 9th, 2020, a period during the national COVID-19 lockdown (March 16th to June 6th, 2020). Special medical and logistic arrangements, priority and visual risk assessment and strict infection control precautions were implemented. Demographics, diagnosis, intravitreal injection history, medical history, ophthalmic examinations and optical coherence tomography data were collected and analyzed. Results: Intravitreal injections were successfully administered to 132 patients with diabetic retinopathy, age-related macular degeneration and retinal vein occlusion. All logistic and transmission control measures were followed by the medical staff and patients with no incidents. No new exposures or COVID-19 positive cases were traced to our location or time of therapy. No complications related to the injections were recorded. The mean period of delay due to the lockdown from the original scheduled appointment was six weeks. Mean visual acuity significantly decreased from 20/55 before the lockdown to 20/70 after the lockdown, and mean central macular thickness significantly increased from 329 to 370 μ. Conclusion: The administration of intravitreal injection therapy during the COVID-19 lockdown under special safety precautions was feasible and successful. Resumption of the essential therapies and medical services during periods of pandemic restrictions while adhering to strict transmission control measures is encouraged.

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Section: Discussionsupporting

confidence: 78%

Clinical Experience in the Administration of Intravitreal Injection Therapy at a Tertiary University Hospital in Jordan During the COVID-19 Lockdown

Saleh¹,

Jammal²,

Alqudah³

et al. 2020

OPTH

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“…Despite VA acuity being maintained at year 2, injection numbers varied widely across regions and remained generally low. 35 It is evident that, as in our study, real-world clinical practice of ranibizumab in DME is characterized by a degree of undertreatment, including lower intensity (i.e., lower injection rates and longer durations between treatments), relative to the treatment regimens evaluated in major clinical trials.…”

Section: Discussionmentioning

confidence: 52%

“… 36 Also in the LUMINOUS TM study, which represents the largest real-world study in medical retina across all approved ranibizumab indications, preliminary results trend to demonstrate similar effectiveness and treatment patterns in the DME cohort. 35 Overall, a gain of 3.5 letters obtained with an average of 4.5 injections was observed in the first year. Despite VA acuity being maintained at year 2, injection numbers varied widely across regions and remained generally low.…”

Section: Discussionmentioning

confidence: 87%

“…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%

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

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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“…Higher injection frequency in the LUMINOUS study was associated with greater VA gains in the global population across all enrolling countries. The good mean letter gains observed at Year 1 suggests that BRVO patients may not need as many ranibizumab injections as other retinal diseases (such as nAMD and DME) to achieve good visual outcomes [25,26]. However, it does confirm that adequate dosing must be maintained to achieve optimal BCVA outcomes.…”

Section: Plos Onementioning

confidence: 98%

Real-world outcomes with ranibizumab in branch retinal vein occlusion: The prospective, global, LUMINOUS study

et al. 2020

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To evaluate the effectiveness, safety, and treatment patterns of ranibizumab 0.5 mg in treatment-naïve patients with branch retinal vein occlusion (BRVO) enrolled in the LUMI-NOUS™ study. Study design A 5-year, global, prospective, multicenter, observational, open-label study conducted in a clinical practice (real-world) setting at outpatient ophthalmology clinics that recruited 30,138 consenting adult patients from all approved indications for ranibizumab across 42 countries. Patients with BRVO were treated according to the local ranibizumab label of the participating countries. Mean change in visual acuity (VA) in Early Treatment Diabetic Retinopathy Study letters from baseline to Year 1, treatment exposure during Year 1, and adverse events (AEs) over 5 years were assessed. Results Of the 1366 recruited BRVO patients, 405 were treatment-naïve at baseline with a mean (standard deviation [SD]) age of 67.9 (12.5) years, 57.5% were female, and 71.8% were

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Effectiveness and safety of ranibizumab 0.5 mg in treatment-naïve patients with diabetic macular edema: Results from the real-world global LUMINOUS study

Cited by 45 publications

References 23 publications

<p>Clinical Experience in the Administration of Intravitreal Injection Therapy at a Tertiary University Hospital in Jordan During the COVID-19 Lockdown</p>

<p>Clinical Experience in the Administration of Intravitreal Injection Therapy at a Tertiary University Hospital in Jordan During the COVID-19 Lockdown</p>

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

Real-world outcomes with ranibizumab in branch retinal vein occlusion: The prospective, global, LUMINOUS study

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