Diabetic Macular Edema (DME)
Conditions
Interventions
investigational material(s)
Generic name etc : Lucentis
INN of investigational material : Ranibizumab
Therapeutic category code : 131 Agents for ophthalmic use
Dosage and Administration for Investigat
Sponsors
Novartis Pharma K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * DME patients with impaired VA aged 20 years or older. * Patients to whom ranibizumab treatment is considered as suitable and who are initiating treatment with ranibizumab for the first time. * Patients not previously treated with any anti-VEGF agents including ranibizumab. * Patient who is expected to follow visit schedule for at least one year. * Willing and able to provide written informed consent personally or by a legally acceptable representative(s).
Exclusion criteria
Exclusion criteria: * Simultaneous participation in a study that includes administration of any investigational drug or procedure. * Planned to be treated with systemic anti-VEGF agents within at least one year from baseline. * Patients contraindicated for ranibizumab treatment as per the Japan package insert: * Patients with a history of hypersensitivity to the ingredients in ranibizumab formulation. * Patients with infection or patients with suspected infection in and/or around the eye. * Patients with inflammation in and/or around the eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Mean change in BCVA from baseline to 12 months The primary effectiveness variable is the change in BCVA in logMAR from Baseline to 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy The time course of BCVA change from Baseline in logMAR for 24 months. efficacy Center subfield thickness (CSFT) other Number of treatment (anti-VEGF agents, combination therapy) other Hospital Anxiety and Depression Scale (HADS) safety Safety(type, frequency, and severity) | — |
Countries
Japan
Outcome results
None listed