Retinal Vein Occlusion
Conditions
Keywords
retinal vein occlusion, branch retinal vein occlusion, central retinal vein occlusion, visual impairment, macular edema, ranibizumab
Brief summary
The purpose of this study is to provide efficacy and safety data of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab in Japanese patients with visual impairment due to macular edema secondary to retinal vein occlusion (BRVO or CRVO) to support the applicability of the phase III study results of BRAVO and CRUISE in this indication, in the Japanese ethnic patients.
Interventions
DRUGranibizumab
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Japanese patients diagnosed with visual impairment exclusively due to macular edema secondary to either branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) Diagnosis within 12 months prior to Visit 1 * Best-corrected visual acuity (BCVA): * CRVO: BCVA score ≥24 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/320 and 20/40) at Visit 1 and 2 * BRVO: BCVA score ≥19 and ≤73 letters ETDRS (approx. Snellen equivalent of 20/400 and 20/40) at Visit 1 and 2
Exclusion criteria
* Pregnant or nursing women * History of stroke * Uncontrolled blood pressure * Active ocular infection or intraocular inflammation in either eye * Uncontrolled glaucoma in either eye * Neovascularization of the iris or neovascular glaucoma in either eye * Prior episode of RVO more than 12 months prior to Visit 1 in the study eye * Use of any systemic anti-VEGF drugs within 6 months prior to Visit 2 * Prior treatment with any anti-angiogenic drugs within 3 months prior to Visit 2 in either eye * Prior panretinal laser photocoagulation within 3 months prior to Visit 2 in the study eye * Prior focal/grid laser photocoagulation within 4 months prior to Visit 2 in the study eye * Use of intra-/peri-ocular corticosteroids within 3 months prior to Visit 1 in the study eye * Use of any intra-ocular corticosteroid implants in the study eye Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure: Efficacy of 3 consecutive monthly intravitreal injections with 0.5 mg ranibizumab as assessed by the mean average change in best-corrected visual acuity (BCVA) from Month 1 through Month 3 compared to baseline | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Measure: Efficacy of monthly ranibizumab injections as assessed by the mean BCVA change from baseline over time to Month 3, by visit | 3 months |
| Measure: Efficacy of monthly ranibizumab injections as assessed by the mean change in central subfield thickness (CSFT) of the retina from baseline over time to Month 3 | 3 months |
| Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients achieving BCVA improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 letters from baseline to Month 3 | 3 months |
| Measure: Efficacy of monthly ranibizumab injections as assessed by the proportion of patients with a BCVA loss of <15 letters from baseline to Month 3 | 3 months |
| Measure: Safety of monthly ranibizumab injections as assessed by the type, frequency and severity of adverse events | 3 months |
Countries
Japan
Outcome results
None listed