This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant after 6 months of treatment. In the study arm Ranibizumab will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
244
Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial. It was suitable for single use only and the content of the vial was not allowed to be split
Comparator Ozurdex® (dexamethasone) was formulated as a rod shaped implant to be inserted into the eye by an applicator. The implant as well as the respective applicator were suitable for single use only.
Sham injection: Empty sterile syringes were provided so that masking could be maintained. Either empty syringes in the case of sham injections or pre-filled syringes in the case of ranibizumab injections were visible to the patient in the room of study drug administration
Mean Average Best Corrected Visual Acuity (BCVA) Change From Month 1 Through Month 6 to Baseline
the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6
Time frame: Baseline, month 6
Mean BCVA Change From Baseline to Endpoints Month 1 to Month 6
The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors
Time frame: Baseline, month 6
Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline
Time frame: Baseline, 6 month
Time to Achieve a Significant Improvement ≥ 15 Letters
The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts
Time frame: Baseline, month 6
Change Over Time in BCVA
The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors
Time frame: baseline, month 6
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Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Leipzig, Germany, Germany
Novartis Investigative Site
Regensburg, Germany, Germany
Novartis Investigative Site
Augsburg, Germany
Novartis Investigative Site
Bad Rothenfelde, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Bochum, Germany
Novartis Investigative Site
Bonn, Germany
Novartis Investigative Site
Bremen, Germany
...and 56 more locations
Change Over Time of the Central Retinal Thickness (CRT)
Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation
Time frame: Baseline, month 6
Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires
The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function.
Time frame: Baseline, month 6
Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires
SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health
Time frame: Baseline, month 6
Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires
The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.
Time frame: Baseline, month 6
Rate of the Internal Ocular Pressure (IOP)
The proportion of patients with ≥ 10% increase in IOP compared to baseline at any post-baseline visit.
Time frame: Baseline, month 6