A 24-month, phase IIIb, open-label, single arm, multicenter study assessing the efficacy and safety of an individualized, stabilization criteria-driven pro re rata (PRN) dosing regimen with 0.5-mg ranibizumab intravitreal injections applied as monotherapy in patients with visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO).
- Conditions
- visual impairment10047060
- Registration Number
- NL-OMON37905
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 25
1. Male or female patients must be at least 18 years of age
2. Diagnosis of visual impairment exclusively due to ME secondary to central retinal vein
occlusion (CRVO)
3. BCVA-sore at Screening and Baseline must be between 73 and 19 letters
Early Treatment Diabetic Retinopathy Study (ETDRS), inclusively (approximate Snellen
chart equivalent of 20/40 and 20/400)
1. Stroke or myocardial infarction less than 3 months prior to Screening
2. Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of
>100 mm Hg at Screening or Baseline. Antihypertensive treatment can be initiated and has to
be taken for at least 30 days after which the patient can be assessed for study eligibility a
second time
3. Any active periocular or ocular infection or inflammation (eg, blepharitis, conjunctivitis,
keratitis, scleritis, uveitis, endophthalmitis) at Screening or Baseline in either eye
4. Uncontrolled glaucoma (intraocular pressure [IOP] >=30 mm Hg on medication or according to
investigator*s judgment) at Screening or Baseline or diagnosed within 6 months prior to
Baseline in either eye
5. Neovascularization of the iris or neovascular glaucoma in either eye
6. Use of any systemic anti-vascular endothelial growth factor (VEGF) drugs within 6 months
prior to Baseline (eg, sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab [Avastin®])
7. Prior treatment with any anti-angiogenic drugs (including any anti-VEGF agents) within
3 months prior to Baseline in either eye (eg, pegaptanib [Macugen®], ranibizumab [Lucentis®],
bevacizumab [Avastin®])
8. Panretinal laser photocoagulation within 3 months prior to Baseline or anticipated or
scheduled within the next 3 months following Baseline in the study eye
9. Focal or grid laser photocoagulation within 4 months prior to Baseline in the study eye
10. Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months prior to
Screening in the study eye
11. Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone
acetonide [Iluvien®]) in the study eye
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy variable is the mean change in BCVA at Month 12 compared<br /><br>to Baseline.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary efficacy endpoints related to the mean change from Baseline will be<br /><br>assessed as per the primary efficacy endpoint. For more information about the<br /><br>secondary study parameters/outcomes please refer to protocol (v00 26May2011)<br /><br>page 42.</p><br>