Study of efficacy and safety of 0.5 mg ranibizumab in Chinese patients with diabetic macular edema (DME)
The purpose of this study was to provide efficacy and safety data on 0.5 mg ranibizumab intravitreal injections compared to laser photocoagulation in Chinese patients with visual impairment due to DME. Treatment was driven by achieving vision stabilization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
384
Ranibizumab 0.5 mg/0.05 mL for intravitreal injection
Laser photocoagulation according to Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines
Imitation of an intravitreal injection consisting of an empty vial and an injection syringe without a needle
Novartis Investigative Site
Mean Average Change From Baseline in Best-Corrected Visual Acuity (BCVA) (Letters) to Month 1 Through 12
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Twelve monthly BCVA values were averaged \[(Month1+Month2+...+Month12)/12\], and the baseline BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Monthly from Month 1 through Month 12
Mean Change From Baseline in BCVA (Letters) at Each Visit
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Monthly from Month 1 through Month 12
Mean Change From Baseline in Central Sub-Field Thickness (CSFT) at Each Visit
CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Optical Coherence Tomography (OCT). A negative change value indicates an improvement in macular edema, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Monthly from Month 1 through Month 12
Percentage of Patients With BCVA Gain of ≥ 10 and ≥ 15 Letters From Baseline at Month 12
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
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Imitation of an active laser
Beijing, Beijing Municipality, China
Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Guangzhou, Guangdong, China
Novartis Investigative Site
Shantou, Guangdong, China
Novartis Investigative Site
Harbin, Heilongjiang, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Changsha, Hunan, China
...and 18 more locations
Time frame: Baseline, Month 12
Percentage of Patients With BCVA Loss of < 10 and < 15 Letters From Baseline to Month 12
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Month 12
Percentage of Patients With BCVA ≥ 73 Letters at Month 12
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. BCVA ≥ 73 letters is approximately equivalent to 20/40 on a Snellen chart. One eye (study eye) contributed to the analysis.
Time frame: Month 12
Mean Average Change in BCVA From Month 4 to Month 12 Compared to Month 3
Visual acuity with eyeglasses was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at an initial testing distance of 4 meters. A letter score was calculated based on the number of letters correctly identified at the specified distance. Nine monthly BCVA values were averaged \[(Month4+Month5+...+Month12)/9\],and the Month 3 BCVA value was subtracted from the average. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis.
Time frame: Monthly from Month 3 through Month 12
Mean Change From Baseline in Patient-Reported Visual Functioning at Month 6 and Month 12, Composite Score
Visual functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in visual functioning, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported General Health at Month 6 and Month 12
General health was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in general health, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported General Vision at Month 6 and Month 12
General vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in general vision, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Color Vision at Month 6 and Month 12
Color vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in color vision, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Peripheral Vision at Month 6 and Month 12
Peripheral vision was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in peripheral vision, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Ocular Pain at Month 6 and Month 12
Ocular pain was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in ocular pain, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Near Activities at Month 6 and Month 12
Near activities were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in near activities, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Distance Activities at Month 6 and Month 12
Distance activities were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in distance activities, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Social Functioning at Month 6 and Month 12
Social functioning was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in social functioning, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Mental Health at Month 6 and Month 12
Mental health was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in mental health, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Roles Difficulties at Month 6 and Month 12
Roles difficulties were assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in roles difficulties, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Dependency at Month 6 and Month 12
Dependency was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in dependency, while a negative change value indicates a worsening.
Time frame: Baseline, Month 6, Month 12
Mean Change From Baseline in Patient-Reported Driving at Month 6 and Month 12
Driving was assessed by the patient using the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) on a scale from 0 to 100, where 0 = worst possible score and 100 = best. A positive change value indicates a perceived improvement in driving, while a negative change value indicates a worsening. Note: Many patients did not answer the driving related question as they did not drive at all.
Time frame: Baseline, Month 6, Month 12
Mean Number of Ranibizumab Re-treatments Received in the Study Eye From Month 3 Onward
A ranibizumab re-treatment was defined as an administration of ranibizumab injection at a scheduled visit following at least one non-missed visit where ranibizumab was not administered in the study eye due to visual acuity stabilization. This outcome measure was pre-specified for the Ranibizumab 0.5 mg arm only.
Time frame: Monthly from Month 3 through Month 12