Ranibizumab treatment of visual impairment caused by occluded vessels (veins) that lead to swelling of the retina in the back of the eye

• Conditions: visual impairment due to macular edema secondary to branch retinal occlusion (BRVO); MedDRA version: 15.1Level: PTClassification code 10025415Term: Macular oedemaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 15.1Level: PTClassification code 10047571Term: Visual impairmentSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 15.1Level: PTClassification code 10038907Term: Retinal vein occlusionSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2011-002859-34-PL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-10
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Written informed consent must be obtained before any study assessment is
performed
• Male or female patients =18 years of age
• Diagnosis of visual impairment exclusively due to ME secondary to BRVO
• 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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Pregnant or nursing (lactating) women
• Stroke or myocardial infarction less than 3 months before Screening
• 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
• Any active periocular or ocular infection or inflammation (eg, blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) at Screening or Baseline in either eye
• 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
• Neovascularization of the iris or neovascular glaucoma in the study eye
• Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline (eg, sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab [Avastin®])
• 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®])
• Panretinal laser photocoagulation within 3 months before Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye
• Focal or grid laser photocoagulation within 4 months before Baseline in the study eye
• Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months before Screening in the study eye
• Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone acetonide [Iluvien®]) in the study eye

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified