visual impairment due to macular edema following central retinal vein occlusion (CRVO) MedDRA version: 14.1 Level: LLT Classification code 10054467 Term: Macular edema System Organ Class: 100000004853
Conditions
Sponsors
Novartis Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 to 20/400 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
Exclusion criteria: 1. Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs 2. Central retinal thickness (CRT) = 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) 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to show that ranibizumab (administered in an individualized treatment regimen) has superior efficacy and safety compared to Dexamethasone implant (Ozurdex®) over a 6 months period. ;Secondary Objective: •To compare the mean BCVA change at Month 6 from Baseline in patients treated with Ozurdex® versus patients treated with ranibizumab •To compare the percentage of patients gaining / losing >= 15, >= 10 and >= 5 letters after the 6-month treatment of ranibizumab versus Ozurdex® compared to baseline. •To compare the time to achieve a significant improvement >= 15 letters under treatment of ranibizumab versus Ozurdex® •To evaluate whether ranibizumab has a higher change over time in BCVA compared with Ozurdex® from Baseline to Month 6 •To compare the change over time of the central retinal thickness after the 6-month treatment •To compare changes in the quality of life according to NEI-VFQ 25, SF36 and EQ-5D questionnaires under treatment of ranibizumab versus Ozurdex® from Baseline to Month 6 •To compare the increase rate of the internal ocular pressure under the treatment of ranibizumab versus Ozurdex® ;Primary end point(s): The primary objective of this study is to demonstrate the superiority of ranibizumab regarding the change in BCVA from baseline to month 6 compared to dexamethasone implant.;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): For the binary secondary endpoints (VA gain/loss = 15/10letters), the absolute and relative frequencies will be tabulated. For treatment comparisons, the difference in proportions and the Odds Ratio will be calculated with the respective confidence intervals and p-values. The time courses of BCVA changes will be displayed graphically (LS-means and treatment contrasts with confidence limits at each measurement time). Time to VA gain = 15 will be analyzed by the Kaplan-Maier-Method.;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Czech Republic, Germany, Hungary, Poland, United Kingdom
Contacts
Public ContactProject Leader
Novartis Pharma GmbH
Outcome results
None listed