TY - JOUR
T1 - Effectiveness and safety of ranibizumab 0.5 mg in treatment-naïve patients with diabetic macular edema: Results from the real-world global LUMINOUS study
AU - Mitchell, Paul
AU - Sheidow, Tom G.
AU - Farah, Michel E.
AU - Mahmood, Sajjad
AU - Minnella, Angelo Maria
AU - Eter, Nicole
AU - Eldem, Bora
AU - Al-Dhibi, Hassan
AU - Macfadden, Wayne
AU - Parikh, Soumil
AU - Dunger-Baldauf, Cornelia
AU - Mahgoub, Mohamed M.
AU - Schmidt-Erfurth, Ursula
PY - 2020
Y1 - 2020
N2 - Purpose
To assess the one-year effectiveness and safety of ranibizumab 0.5 mg in treatment- naïve
patients with diabetic macular edema (DME) enrolled in the real-world LUMINOUS study.
Patients and methods
A 5-year, prospective, observational, open-label, global study which recruited 30,138
patients across all approved indications. Consenting patients (�18 years) who were treatment-
naïve or previously treated with ranibizumab or other ocular treatments were treated
as per the local ranibizumab label. Here, we present the change in visual acuity (VA) (Early
Treatment Diabetic Retinopathy Study letter score; primary treated eye) at Year 1, as well
as the change in VA based on injection frequencies (�4 and �5), treatment exposure, and
the overall adverse events (AEs) and serious AEs (SAEs) in treatment-naïve DME patients.
Results
Of the 4,710 DME patients enrolled in the study, 1,063 were treatment-naïve. At baseline,
mean age was 64.5 years, 54.7% were male, and 69.2% were white. At 1 year, mean VA letter
score improved by +3.5 (n = 502) from a baseline of 57.7 with a mean of 4.5 injections.Presented by injection frequencies �4 and �5, VA letter score gains were 0.5 (n = 264) and
6.9 (n = 238) from baseline letter scores of 56.6 and 59.0, respectively. Over 5 years, the
incidence of ocular/non-ocular AEs and SAEs was 7.2%/10.1% and 0.3%/5.8%, respectively.
No endophthalmitis cases were reported.
Conclusions
The LUMINOUS study included patients with DME with more diverse baseline characteristics
than those in randomized clinical trials. The 1-year data showed improvement in VA with
low number of injections in treatment- naïve patients with DME. Greater VA gains were
observed in patients who received �5 injections. No new safety findings were identified.
LUMINOUS confirms the effectiveness and safety of ranibizumab for the treatment of
patients with DME in a real-world clinical practice.
AB - Purpose
To assess the one-year effectiveness and safety of ranibizumab 0.5 mg in treatment- naïve
patients with diabetic macular edema (DME) enrolled in the real-world LUMINOUS study.
Patients and methods
A 5-year, prospective, observational, open-label, global study which recruited 30,138
patients across all approved indications. Consenting patients (�18 years) who were treatment-
naïve or previously treated with ranibizumab or other ocular treatments were treated
as per the local ranibizumab label. Here, we present the change in visual acuity (VA) (Early
Treatment Diabetic Retinopathy Study letter score; primary treated eye) at Year 1, as well
as the change in VA based on injection frequencies (�4 and �5), treatment exposure, and
the overall adverse events (AEs) and serious AEs (SAEs) in treatment-naïve DME patients.
Results
Of the 4,710 DME patients enrolled in the study, 1,063 were treatment-naïve. At baseline,
mean age was 64.5 years, 54.7% were male, and 69.2% were white. At 1 year, mean VA letter
score improved by +3.5 (n = 502) from a baseline of 57.7 with a mean of 4.5 injections.Presented by injection frequencies �4 and �5, VA letter score gains were 0.5 (n = 264) and
6.9 (n = 238) from baseline letter scores of 56.6 and 59.0, respectively. Over 5 years, the
incidence of ocular/non-ocular AEs and SAEs was 7.2%/10.1% and 0.3%/5.8%, respectively.
No endophthalmitis cases were reported.
Conclusions
The LUMINOUS study included patients with DME with more diverse baseline characteristics
than those in randomized clinical trials. The 1-year data showed improvement in VA with
low number of injections in treatment- naïve patients with DME. Greater VA gains were
observed in patients who received �5 injections. No new safety findings were identified.
LUMINOUS confirms the effectiveness and safety of ranibizumab for the treatment of
patients with DME in a real-world clinical practice.
KW - Angiogenesis Inhibitors
KW - Diabetic Retinopathy
KW - Intravitreal Injections
KW - Macular Edema
KW - Ranibizumab
KW - Angiogenesis Inhibitors
KW - Diabetic Retinopathy
KW - Intravitreal Injections
KW - Macular Edema
KW - Ranibizumab
UR - http://hdl.handle.net/10807/179112
U2 - 10.1371/journal.pone.0233595
DO - 10.1371/journal.pone.0233595
M3 - Article
SN - 1932-6203
VL - 2020
SP - N/A-N/A
JO - PLoS One
JF - PLoS One
ER -
