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 central retinal vein occlusion (CRVO); MedDRA version: 14.1Level: PTClassification code 10025415Term: Macular oedemaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: PTClassification code 10047571Term: Visual impairmentSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10007972Term: Central retinal vein occlusionSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2011-002350-31-NL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-16
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

- Written informed consent must be obtained before any study assessment is performed- Male or female patients must be at least 18 years of age
- Diagnosis of visual impairment exclusively due to ME secondary to central retinal vein occlusion (CRVO)
- Best-corrected visual acuity 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)

Other protocol-defined inclusion criteria may apply
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 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 245

Exclusion Criteria

• Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test
• Stroke or myocardial infarction less than 3 months prior to 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 has to 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 on medication or according to investigator’s judgment) at Screening or Baseline or diagnosed within 6 months prior to Baseline in either eye
• Neovascularization of the iris or neovascular glaucoma in either eye
• Use of any systemic anti-vascular endothelial growth factor (VEGF) drugs within 6 months prior to Baseline (eg, sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab [Avastin®])
• 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®])
• Panretinal laser photocoagulation within 3 months prior to Baseline or anticipated or scheduled within the next 3 months following Baseline in the study eye
• Focal or grid laser photocoagulation within 4 months prior to Baseline in the study eye
• Use of intra- or periocular corticosteroids (including sub-Tenon) within 3 months prior to Screening in the study eye
• Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone acetonide [Iluvien®]) in the study eye

Other protocol-defined exclusion criteria may apply

Study & Design

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