Antibody treatment in retinal vein occulsion and the influence on oxygen and blood supply

Phase 1

• Conditions: retinal vein occlusion; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2016-001660-10-AT
• Lead Sponsor: niversitätsklinik für Augenheilkunde und Optometrie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-25
• Last Update Posted: 6 November 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

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 Eylea®.
•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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

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
•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.
•Hypersensitivity to the active substance aflibercept or to any of the excipients (Polysorbate 20, Sodium dihydrogen phosphate, monohydrate, Disodium hydrogen phosphate, heptahydrate, Sodium chloride, Sucrose)
•Active or suspected ocular or periocular infection in the study eye.
•Active intraocular inflammation (grade trace or above) in the study eye.
•Any active infection involving eyeball adnexa
•Pregnant or breast-feeding women.
•Women of childbearing potential with either a positive pregnancy test result or no
pregnancy test at baseline are excluded. Postmenopausal women must be amenorrheic
for at least 12 months in order not to be considered of child bearing potential.
•Sexually active men or women of childbearing potential who are unwilling to practice
adequate contraception during the study are excluded. (adequate contraceptive
measures include stable use of oral contraceptives or other prescription
pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening;
intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus
contraceptive sponge, foam, or jelly or diaphragm plus contraceptive sponge, foam, or
jelly)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Changes in retinal ischemia (area) after intravitreal Eylea® treatment.;Secondary Objective: Best-corrected visual acuity, anatomic changes in the macula region as assessed with a SS-OCT (swept source OCT), angiographic outcomes oxygen extraction, macular function using microperimetry, correlation between Doppler OCT/Oxygen extaction of retinal vessels and perfusion in fluorescein angiography;Primary end point(s): Changes in retinal ischemia (area) after intravitreal Eylea® treatment.;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Best-corrected visual acuity, anatomic changes in the macula region as assessed with a SS-OCT (swept source OCT), angiographic outcomes oxygen extraction, macular function using microperimetry, correlation between Doppler OCT/Oxygen extaction of retinal vessels and perfusion in fluorescein angiography;Timepoint(s) of evaluation of this end point: 6 months