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Randomized trial comparing injection frequency between Aflibercept and Ranibizumab in patients with Central Retinal Vein Occlusion with a treat and extent algorithm

Randomized trial comparing injection frequency between Aflibercept and Ranibizumab in patients with Central Retinal Vein Occlusion with a treat and extent algorithm

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-001047-21-SE
Enrollment
Unknown
Registered
2014-04-11
Start date
2014-06-09
Completion date
Unknown
Last updated
2015-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central retinal vein occlusion

Interventions

Trade Name: Eylea Product Name: Aflibercept Pharmaceutical Form: Solution for injection INN or Proposed INN: Aflibercept Other descriptive name: AFLIBERCEPT Concentration unit: mg/ml milligram(s)/mill

Sponsors

Sankt Eriks Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary end point(s): Difference in visual acuity after 18 months;Timepoint(s) of evaluation of this end point: 18 months—

Countries

Sweden

Contacts

Public ContactSankt Eriks Eye Hospital

Sankt Eriks Eye Hospital

david.epstein@sankterik.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026