A 12-month, randomized, double-masked, sham-controlled, multicenter study to evaluate the efficacy and safety of 0.5 mg ranibizumab intravitreal injections in patients with visual impairment due to vascular endothelial growth factor (VEGF) driven macular edema (ME) (CRFB002G2302)
- Conditions
- macular edema10047060
- Registration Number
- NL-OMON40497
- Lead Sponsor
- ovartis Pharma BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
* Male or female patients at least 12 (in NL: 18) years of age.
* Naïve active ME secondary to any causes (for adult patients: except DME and RVO). See protocol page 25 for details.
* Visual impairment predominantly only due to the presence of any eligible types of ME, see protocol page 25 for details.
* BCVA score at Screening and Baseline * 24 and * 83 letters (see protocol page 25 for details).
* Pregnant or nursing (lactating) women. Women of child-bearing potential, not practicing adequate contraception.
* Stroke less than 6 months prior to Screening.
* Systolic BP >160 mm Hg or diastolic BP >100 mm Hg at Screening or Baseline.
* Any active systemic inflammation or infection related directly to the underlying causal disease of ME at screening.
* Active diabetic retinopathy, active ocular/periocular infectious disease or active intraocular inflammation at screening.
* Intraocular pressure * 25 mmHg.
* Neovascularization of the iris or neovascular glaucoma.
* Exclusion criteria study eye and prior or current medications: see protocol page 27-28.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>BCVA change from baseline to month 2.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Time course of BCVA and OCT parameters, active ME leakage, rescue treatment<br /><br>month 1, ranibizumab requirements over time. Adverse events.</p><br>