Ranibizumab "Treat and Extend" in Diabetic Macular Edma
- Registration Number
- NCT01297569
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
- Visual impairment due to focal or diffuse macular edema with center involvement
- Diabetes type 1 or 2, HbA1c < 12.0%
- CRT = or > 250 μm
Exclusion Criteria
- Active inflammation or infection
- Uncontrolled glaucoma
- Iris neovascularization, active proliferative retinopathy or vitreomacular traction
- Prior laser photocoagulation according to defined timelines
- History of stroke, uncontrolled hypertension
Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ranibizumab Ranibizumab -
- Primary Outcome Measures
Name Time Method Change in Best Corrected Visual Acuity(BCVA) from month 0 (baseline) to month 12
- Secondary Outcome Measures
Name Time Method change in central retinal thickness (CRT) from month 0 to month 12 the number of injections needed 12 months the number of patients with improvement in BCVA from baseline 12 months the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84 12 months
Trial Locations
- Locations (1)
Novartis Investigative Site
🇳🇴Oslo, Norway