Macular Edema Due to BRVO/CRVO Clinical Trial
Official title:
Predictive Factors of 2-year Visual Outcome in Retinal Vein Occlusion Following Intravitreal Ranibizumab Treatment
| Verified date | March 2017 |
| Source | Kyoto University, Graduate School of Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
In retinal vein occlusion, predictive factors for visual outcome after ranibizumab treatment have not been evaluated comprehensively. Therefore, we have planned to analyze predictors for visual outcome from a viewpoint of electrophysiology and biomarkers besides morphological features by SD-OCT.
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | September 2019 |
| Est. primary completion date | September 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Signed informed consent form - Male or female of aged 18 years or older - Macula edema secondary to BRVO/CRVO - Decrease of VA due to macular edema Exclusion Criteria: - Prior episode of RVO - Previous treatment with anti-VEGF drugs or corticosteroid or grid laser photocoagulation (study eye) - Ocular disorders in the study eye that may confound interpretation of study results - History of vitrectomy surgery, submacular surgery, or other surgical intervention for RVO - The pregnant or lactating woman |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Department of Ophthalmology, Kyoto University Hospital | Kyoto |
| Lead Sponsor | Collaborator |
|---|---|
| Kyoto University, Graduate School of Medicine | Novartis |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean foveal thickness measured by SD-OCT | 2 years |