Randomized trial comparing injection frequency between Aflibercept and Ranibizumab in patients with Central Retinal Vein Occlusion with a treat and extent algorithm
- Conditions
- Central retinal vein occlusionTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2014-001047-21-SE
- Lead Sponsor
- Sankt Eriks Eye Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
CRVO - naive patients
CRVO with a maximum duration of 12 months
>18y
Fertile women: Negative pregnancy test and use of contraceptive 3 months after last treatment
BCVA : ETDRS 23-73 letters (20/40 – 20/320)
Macular edema > 300 µm (Cirrus)
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
CRVO with neovascularization
Any previous treatment for CRVO.
Intraocular surgery during the previous 3 months.
Vascular retinopathy of other causes.
Active ocular infection or inflammation.
Myocardial infarction or stroke during the last 3 months.
Sensitivity to aflibercept or one of the excipients (Polysorbate 20, Sodium dihydrogen phosphate, monohydrate, Disodium hydrogen phosphate, heptahydrate, Sodium chloride, Sucrose, Water for injection
Sensitivity to ranbizumab or one of the excipients (Trehalose dihydrate, histidine hydrochloride monohydrate, histidine, polysorbate 20, water for injections)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Comparing ranibizumab and aflibercept in a treat and extent algorithm evaluating the number of needed injections over a 18 month period ;Secondary Objective: Comparing ranibizumab and aflibercept in a treat and extent algorithm evaluating the visual outcome and macular edema;Primary end point(s): Difference in number of injections after 18 months;Timepoint(s) of evaluation of this end point: 18 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Difference in visual acuity after 18 months;Timepoint(s) of evaluation of this end point: 18 months