Retinal vein occlusion MedDRA version: 14.1 Level: LLT Classification code 10066426 Term: Hemiretinal vein occlusion System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: LLT Classification code 10007972 Term: Central retinal vein occlusion System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: PT Classification code 10038907 Term: Retinal vein occlusion System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: Ozurdex 700mg intravitreal implant
Product Name: Ozurdex
Pharmaceutical Form: Intravitreal implant in applicator
INN or Proposed INN: Dexamethasone
Other descriptive name: DEXAMETHASONE
Co
Sponsors
Universitätsklinik für Augenheilkunde und Optometrie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: • Male or female, at least 18 years of age. • Ophthalmoscopic evidence of recent BRVO or CRVO (i.e. a history of 3 months or less). • Macular edema secondary to BRVO or CRVO in the study eye sheduled for intravittreal Ozurdex®. • Retinal thickness of > 300 µm by OCT in the central subfield of the study eye at baseline. • VA decrease attributable to the edema. • Written informed consent has been obtained. • Female patients of childbearing potential must have a negative urine pregnancy test. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Exclusion criteria Any of the following will exclude a subject from the study: • Uncontrolled systemic disease • Symptoms of a clinically relevant illness in the 3 weeks before the first study day • Any ocular condition that, in the opinion of the investigator, would prevent a 15-letter improvement in visual acuity (eg severe macular ischemia) • History of glaucoma, aphakia or presence of anterior chamber intraocular lens, active retinal neovascularization, choroidal neovascularization, significant cataract, presence of rubeosis iridis, any ocular infection, history of pars plana vitrectomy, anticipated need for ocular surgery in the study eye during the study period. • Contraindication to pupil dilation, known allergy, or contraindication to the use of fluorescein.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of intravitreal Ozurdex® treatment on the anterior chamber cytokine and growth factor profile after either CRVO or BRVO;Secondary Objective: Retinal vessel diameters, retrobulbar flow velocities, best-corrected visual acuity, macular sensitivity assessed with Microperimetry, anatomic changes in the macula region as assessed with a Spectralis-OCT, angiographic outcomes;Primary end point(s): Intraocular concentrations of cytokines and growth factors ;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Retinal vessel diameters, • retrobulbar flow velocities, • best-corrected visual acuity, • macular sensitivity assessed with Microperimetry OPCO, • anatomic changes in the macula region as assessed with a Spectralis-OCT, • alteration in retinal pigment epithelium as assessed with POL-OCT • angiographic outcomes. ;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Austria
Contacts
Public ContactMUW
Universitätsklinik für Augenheilkunde und Optometrie, Medizinische Universität Wien
Outcome results
None listed