A 24-month, phase IIIb, open-label, randomized, active-controlled, 3-arm, multicenter study assessing the efficacy and safety of an individualized, stabilization-criteria-driven pro re nata (PRN) dosing regimen with 0.5-mg ranibizumab intravitreal injections applied as monotherapy or with adjunctive laser photocoagulation in comparison to laser photocoagulation in patients with visual impairment due to macular edema secondary to branch retinal vein occlusion (BRVO)
- Conditions
- visual impairment10047060
- Registration Number
- NL-OMON37792
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 21
1. Male or female patients >=18 years of age
2. Diagnosis of visual impairment exclusively due to ME secondary to BRVO
3. BCVA score at Screening and Baseline 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 before 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 must 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 while on
medication or according to investigator*s judgment) at Screening or Baseline or
diagnosed within 6 months before Baseline in either eye
5. Neovascularization of the iris or neovascular glaucoma in the study eye
6. Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs
within 6 months before Baseline (eg, sorafenib [Nexavar®], sunitinib [Sutent®],
bevacizumab [Avastin®])
7. Treatment (or anticipated treatment in the fellow eye for non-RVO indications
during the study) with any anti-angiogenic drugs (including any anti-VEGF agents)
within 3 months before Baseline in either eye (eg, pegaptanib [Macugen®],
ranibizumab [Lucentis®], bevacizumab [Avastin®])
8. Panretinal laser photocoagulation within 3 months before 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 before Baseline in the study
eye
10. Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months
before Screening in the study eye
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary variable is the mean BCVA change at Month 6 compared to Baseline in<br /><br>patients with visual impairment due to ME secondary to BRVO. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Key secondary<br /><br>variables include the mean average BCVA change from Month 1 to Month 24<br /><br>compared to Baseline and the number of ranibizumab treatments.</p><br>