A 12-Month, Multicentre, Randomised, Parallel Group Study to Comparethe Efficacy and Safety of Ozurdex Versus Lucentis in Patients withBranch Retinal Vein Occlusion
- Conditions
- Macula oedema secondary to branch retinal vein occlusionMedDRA version: 14.1Level: PTClassification code 10025415Term: Macular oedemaSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2010-023900-29-IT
- Lead Sponsor
- ALLERGAN PHARMACEUTICALS IRELAND
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 307
1. Male or female, = 18 years of age 2. Written informed consent has been obtained 3. Written Data Protection Consent (European sites only) has been obtained 4. Study eye must have clear ocular media and adequate pupil dilation to permit good quality photographic imaging 5. ME secondary to BRVO in the study eye with all of the following characteristics: a) involving the centre of the macula (fovea) b) central retina subfield thickness = 320 µm as assessed with Spectralis optical coherence tomography (OCT) or = 300 µm as assessed with Cirrus OCT c) less than 90 days from onset of BRVO symptoms to screening visit d) visual acuity (VA) decrease attributable to retinal oedema Note: Characteristics a and b will be confirmed by a CRC 6. Absence of severe macular ischemia (defined as an area of nonperfusion > 4 disc areas [DA] which involve the foveal avascular zone), as confirmed by a CRC 7. BCVA score of = 20 to = 70 letters (20/40 to 20/400 Snellen equivalent) using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity protocol at both the screening visit and day 1 visit. 8. Female subjects of childbearing potential must have a negative urine pregnancy test at the screening (day -14) visit
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200
1.History of a medical condition that, in the opinion of the investigator, would preclude scheduled study visits, completion of the study, or a safe administration of study medication. 2.Ocular hypertension unless controlled with monotherapy. 3.Pregnant or nursing (lactating) women, 4.Pre-menopausal women of child-bearing potential not using adequate Contraception. 5.Participation in an investigational drug or device study within 30 days of the screening visit. 6.Any current or history of ocular disease in the study eye other than RVO that, in the opinion the investigator, may confound assessment of the macula or affect central vision, such as exudative age-related macular degeneration, geographic atrophy, diabetic retinopathy, uveitis, streaks, histoplasmosis, pathological myopia, retinal detachment, epiretinal membrane, macular hole, or significant cataract 7.History of cataract surgery in either eye within the past 3 months prior to the screening visit 8.History or evidence of serious ocular trauma or intraocular surgery (such as laser-assisted in situ keratomileusis, keratoplasty, vitrectomy) in the study eye within the past 6 months prior to the screening visit 9.History of severe or serious hypersensitivity to any components of the test article or fluorescein dye. 10.> 10-Letter improvement in BCVA between the screening visit and day 1 11.Brisk afferent pupillary defect (ie, obvious and unequivocal) 12.Aphakia in the study eye or violation of the posterior capsule in the study eye, unless it occurred as a result of a yttrium-aluminum-garnet laser posterior capsulotomy in association with prior, posterior intraocular lens implantation 13.Any active ocular infection (ie, bacterial, viral, parasitic, or fungal) in adnexa of either eye 14.History of radial optic neurotomy or sheathotomy 15.Laser photocoagulation for ME in the study eye within 3 months prior to the screening visit 16.Anticipated need for ocular surgery or ophthalmic laser treatment in the study eye during the 12-month study period 17.Prior anti-VEGF treatment in study or fellow eye within 3 months of screening or systemic anti-VEGF treatment within 6 months of the screening visit 18.Use of intraocular, intravitreal, or peri-ocular steroids in the study eye within 3 months of the screening visit 19.Use of systemic steroids (eg, oral, intravenous, intra-articular, epidural, intrabursal) within 1 month of screening or anticipated use at any time during the study. Inhaled and intranasal steroids are allowed. 20.IOP > 22 mm Hg at screening or day 1 visit in either eye.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the efficacy and safety of Ozurdex vs. Lucentis in subjects with BRVO;Secondary Objective: None;Primary end point(s): The primary efficacy variable is mean change in BCVA at month 12.;Timepoint(s) of evaluation of this end point: BCVA assessment at screening, baseline, day 7 and at each monthly visit
- Secondary Outcome Measures
Name Time Method