macular edema, branch retinal vein occlusion
Conditions
Interventions
Group A: group to receive intravitreal injection of ranibizumab BS
Group B: group to receive intravitreal injection of aflibercept
ranibizumab BS, aflibercept, intravitreal injection
Sponsors
Nakao Shintaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria are included in this study; 1. Patients aged 50 years or older at consenting, who have ability to give their consent, and who can give their consent by written form by their free will 2. Patients who are diagnosed with macular edema associated with branch retinal vein occlusion (BRVO), and who require treatment with anti-VEGF antibodies 3. Patients who are diagnosed that the onset of the BRVO occurred within 6 months before consenting 4. Patients whose best-corrected visual acuity (Number of characters in ETDRS) in the study eye is 20 or higher and 70 or less (decimal visual acuity equivalent of 0.05 to 0.5) 5. Patients whose foveal retinal thickness measured by OCT (SD-OCT) is 300 micrometers or thicker 6. Patients who are judged by investigators to be appropriate to assess the efficacy and safety in this study, considering the inclusion and exclusion criteria in this study
Exclusion criteria
Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study; 1. Patients whose sytolic blood pressure is 200mmHg or higher, or whose diasolic blood pressure is 110mmHg or higher at enrollment 2. Patients with history of intravitreal injection of corticosteroid or anti-VEGF antibodies to the study eye 3. Patients with history of panretinal laser photocoagulation or macular laser photocoagulation to the study eye 4. Patients with other macula disease, iris neovessel, vitreous hemorrhage, traction retinal detachment, or epiretinal membrane 5. Patients with history of vitreous surgery to the study eye 6. Pregnant or possibly pregnant female, breastfeeding female, female who wish to become pregnant after consenting till the end of the observation period, or female who do not agree to contraception 7. Patients with severe systemic disease (cancer, cardiac disease, hepatic disease, renal disease, endocrine system disease, etc.) 8. Patients who are judged by investigators to be inappropriate to participate in this study, considering the history of severe disease and current health conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in best-corrected visual acuity (Number of characters in ETDRS) from baseline to week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. mean change in foveal retinal thickness measured by OCT from baseline to week 24 2. proportion of patients who improve 15 characters or more in the best-corrected visual acuity (Number of characters in ETDRS) from baseline to week 24 3. mean number of intravitreal injection of study agent or control agent 4. mean change in QOL (NEI VFQ-25) from baseline to week 24 5. mean change in blood VEGF concentration from baseline to week 4 6. mean change in best-corrected visual acuity (Number of characters in ETDRS) from baseline to each observation point (except primary endpoint) 7. mean change in foveal retinal thickness measured by OCT from baseline to each observation point 8. proportion of patients who improve 15 characters or more in the best-corrected visual acuity (Number of characters in ETDRS) from baseline to each observation point 9. mean change in QOL (NEI VFQ-25) from baseline to each observation point 10. mean change in blood VEGF concentration from baseline to each observation point 11. degree and frequency of adverse event or disease-or-the-like | — |
Contacts
Public ContactAi Toride
Juntendo University Hospital
Outcome results
None listed