Table 1.
Patient disposition of treatment-naïve patients with DME (safety set).
Table 2.
Baseline demographic, ocular, and disease characteristics for treatment-naïve DME patients (primary treated eye set).
Table 3.
Relevant ocular and non-ocular medical history/comorbidities for treatment-naïve DME patients.
Fig 1.
LUMINOUS study overview: World map showing overall recruitment with countries enrolling highest treatment-naïve patients with DME.
The pop out boxes represent the number (%) of treatment-naïve patients with DME in the top. Equal recruitment numbers were achieved in Turkey and Germany. DME, diabetic macular edema.
Fig 2.
Mean change in visual acuity by injection frequency in treatment-naïve patients with DME (N = 502; primary treated eye set).
Observed dataset for VA change. The primary treated eye set included all primary treated eyes in patients included in the safety set. The safety set consisted of patients in the enrolled set who were treated with at least one dose of ranibizumab during this study or prior to the start of the study and had at least one safety assessment after the first treatment. For treatment-naïve eyes, the date of first on-study injection with ranibizumab was considered the baseline date. For the 1-year time period, all patients with non-missing baseline VA and year 1 VA performed anywhere between Day 319 and Day 409 but who had been in the study for at least 365 days from baseline to last follow-up date were included in the analysis. DME, diabetic macular edema; ETDRS, Early Treatment Diabetic Retinopathy Study; VA, visual acuity.
Fig 3.
Mean change in visual acuity in patients with and without loading doses (primary treated eye set).
*Three initial consecutive injections at 4 weekly intervals. Observed dataset for VA change. The primary treated eye set included all primary treated eyes in patients included in the safety set. The safety set consisted of patients in the enrolled set who were treated with at least one dose of ranibizumab during this study or prior to the start of the study and had at least one safety assessment after the first treatment. For treatment-naïve eyes, the date of first on-study injection with ranibizumab was considered the baseline date. For the 1-year time period, all patients with non-missing baseline VA and year 1 VA performed anywhere between Day 319 and Day 409 but who had been in the study for at least 365 days from baseline to last follow-up date were included in the analysis.BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; VA, visual acuity.
Fig 4.
Mean change in visual acuity by baseline visual acuity stratification (primary treated eye set).
Observed data set for VA change. The primary treated eye set included all primary treated eyes in patients included in the safety set. The safety set consisted of patients in the enrolled set who were treated with at least one dose of ranibizumab during this study or prior to the start of the study and had at least one safety assessment after the first treatment. *The values represent the final VA at year 1. For treatment-naïve eyes, the date of first on-study injection with ranibizumab was considered the baseline date. For the 1-year time period, all patients with non-missing baseline VA and year 1 VA performed anywhere between Day 319 and Day 409 but who had been in the study for at least 365 days from baseline to last follow-up date were included in the analysis. ETDRS, Early Treatment Diabetic Retinopathy Study; VA, visual acuity.
Fig 5.
Proportion of patients with a VA gain or loss (primary treated eye set).
*Includes patients with 0 letters loss. The primary treated eye set included all primary treated eyes in patients included in the safety set. The safety set consisted of patients in the enrolled set who were treated with at least one dose of ranibizumab during this study or prior to the start of the study and had at least one safety assessment after the first treatment. For treatment-naïve eyes, the date of first on-study injection with ranibizumab was considered the baseline date. For the 1-year time period, all patients with non-missing baseline VA and year 1 VA performed anywhere between Day 319 and Day 409 but who had been in the study for at least 365 days from baseline to last follow-up date were included in the analysis. ETDRS, Early Treatment Diabetic Retinopathy Study; VA, visual acuity.
Fig 6.
Frequency of injections over 12 months (N = 502, safety set).
The safety set consisted of patients in the enrolled set who were treated with at least 1 dose of ranibizumab during this study or prior to start of study and had at least 1 safety assessment after the first treatment. 1.4% (n = 7), 1.0% (n = 5), and 0.4% (n = 2) of patients received 10, 11, and 12 injections respectively. n = number of evaluable patients with baseline and year 1 data. For treatment-naïve eyes, the date of first on-study injection with ranibizumab was considered the baseline date. For the 1-year time period, all patients with non-missing baseline VA and year 1 VA performed anywhere between Day 319 and Day 409 but who had been in the study for at least 365 days from baseline to last follow-up date were included in the analysis. VA, visual acuity.
Fig 7.
Mean change in visual acuity, baseline visual acuity, and average injection numbers across various regions (primary treated eye set).
The primary treated eye set included all primary treated eyes in patients included in the safety set. Top recruiting countries (treatment-naïve DME) with highest evaluable baseline and year 1 data. For the 1-year time period, all patients with non-missing baseline VA and year 1 VA performed anywhere between Day 319 and Day 409 but who had been in the study for at least 365 days from baseline to last follow-up date were included in the analysis. DME, diabetic macular edema; ETDRS, Early Treatment Diabetic Retinopathy Study; VA, visual acuity.
Table 4.
Ocular (primary treated eye) and non-ocular adverse events in treatment-naïve patients with DME.
Table 5.
Ocular (primary treated eye) and non-ocular serious adverse events in treatment-naïve patients with DME.