Steroid therapy for retinal vein occlusion and the influence on intraocular inflammatio

Phase 1

• Conditions: Retinal vein occlusion; MedDRA version: 14.1Level: LLTClassification code 10066426Term: Hemiretinal vein occlusionSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10007972Term: Central retinal vein occlusionSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: PTClassification code 10038907Term: Retinal vein occlusionSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-000800-13-AT
• Lead Sponsor: niversitätsklinik für Augenheilkunde und Optometrie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-08
• Last Update Posted: 29 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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 <br>;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Retinal vessel diameters, <br>•retrobulbar flow velocities, <br>•best-corrected visual acuity, <br>•macular sensitivity assessed with Microperimetry OPCO, <br>•anatomic changes in the macula region as assessed with a Spectralis-OCT, <br>•alteration in retinal pigment epithelium as assessed with POL-OCT<br>•angiographic outcomes.<br>;Timepoint(s) of evaluation of this end point: 6 months