Comparison of Lucentic (Ranibizumab) and Ozurdex (Dexamethasone) for the treatment of patients with visual impairment due to macular edema following central retinal vein occlusio

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

Inclusion Criteria

1.Male and female patients aged >= 18 years
2.Patients diagnosed with visual impairment due to macular edema following CRVO; diagnosis of CRVO at maximum 6 months prior to Screening
The following definition of CRVO will be used for the purposes of this study:
An eye that has retinal hemorrhages or other biomicroscopic evidence of CRVO (e.g. telangiectatic capillary bed) and a dilated venous system (or previously dilated venous system) in three quadrants or more of the retina drained by the affected vein. The presence of a CRVO will be centrally assessed by fluorescein angiography.
3.BCVA using ETDRS charts of 20/40 (6/12 in metres)to 20/400(6/120 in metres) in the study eye
4.Signed Informed Consent

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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

Exclusion Criteria

1.Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs
2.Central retinal thickness (CRT) < 250 µm in the study eye
3.Prior episode of RVO in the study eye
4.History of radial optic neurotomy or sheathotomy in the study eye
5.History or presence of AMD (dry or wet form) in the study eye
6.Active neovascularization in the study eye
7.Aphakia in the study eye
8.Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline
9.Panretinal scatter photocoagulation or sector laser photocoagulation within 3 months prior to Baseline or anticipated within the next 4 months following randomization
10.Intraocular corticosteroid use within 6 months prior to Baseline
11.History of pars plana vitrectomy
12.Intraocular surgery within 2 months prior to Baseline or anticipated within the next 6 months following randomization
13.Yttrium-aluminium-garnet (YAG) capsulotomy performed within 2 months prior to Baseline
14.Combined arterio-venous occlusion
15.Previous filtration surgery in the study eye
16-19History of herpetic ocular infection, ocular toxoplasmosis, macular detachment or central serous chorioretinopathy
20.Evidence upon examination of vitreoretinal interface disease (e.g. vitreomacular traction, epiretinal membrane), either on clinical examination or OCT, thought to be contributing to macular edema
21.An eye that, in the investigator’s opinion, would not benefit from resolution of macular edema, such as eyes with foveal atrophy, dense pigmentary changes, or dense subfoveal hard exudates
22.Any active infection in either eye (internal or external)
23.IOP >= 30mmHg or uncontrolled glaucoma; patients may be re-screened after 1 month if they have undergone glaucoma treatment
24.Known steroid responders
25.Any ocular condition that, in the opinion of the investigator, would alter the study outcome (e.g. uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass syndrome, or prior macula-off rhegmatogenous retinal detachment)
26.Visually significant hemorrhage obscuring the fovea and felt to be a major contributor to visual acuity. The patient should be followed and when the hemorrhage in the fovea clears to the point that it is not longer considered to be a major contributor to reduced visual acuity, the patient may be screened for the study.
27.Presence of a substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e. a 20/40 cataract)
28.Evidence upon examination of pseudoexfoliationglaucom
29.Evidence upon examination of any diabetic retinopathy, defined as eyes of diabetic patients with more than one microaneurysm outside the area of the vein occlusion (includes the study eye as well as the partner eye)
30.Relevant ocular disease that may be associated with increased intraocular VEGF levels (namely uveitis, neovascular glaucoma, neovascular AMD, diabetic retinopathy, diabetic maculopathy, or ocular ischemic syndrome)
31.History of cerebral vascular accident or myocardial infarction within 12 months prior to Baseline
32.Improvement of > 10 letters on BCVA between Screening and Baseline.
33.Relevant systemic disease that may be associated with increased systemic VEGF levels (namely all active malignancies; history of successfully treated malignancies is not an exclusion criterion)
34.Uncontrolled blood pressure (defined as a systolic

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

Comparison of Lucentic (Ranibizumab) and Ozurdex (Dexamethasone) for the treatment of patients with visual impairment due to macular edema following branch retinal vein occlusio

ovartis Pharma GmbH

Updated 7/15/2013