Provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to CRVO
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
252
Sham injections referred to the imitation of an intravitreal injection using an injection syringe without needle.
Ranibizumab solution for injection was supplied in vials. Each vial contained ranibizumab concentration of 10mg/mL labeled as 0.5 mg/0.5 mL, corresponding to a 0.5 mg dose level. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial for single use only
Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3
Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 3 and compared to Baseline.
Time frame: Baseline, 3 Months
Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12
Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline
Time frame: Baseline, 12 months
Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time
Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline
Time frame: Month 1 to 12 months
Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time
OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center.
Time frame: Month 1 to month 12
Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Beijing, Beijing Municipality, China
Novartis Investigative Site
Chongqing, Chongqing Municipality, 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
Changsha, Hunan, China
Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Nanjing, Jiangsu, China
...and 24 more locations
Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.
Time frame: Month 1 to month 12
Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time
Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.
Time frame: Month 1 to 12 months
The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline
The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.
Time frame: Month 3,6 and 12