St Eriks Eye Hospital
Stockholm, 11282, Sweden
NCT Number: NCT02274259
Comparing ranibizumab and aflibercept in a treat and extend algorithm evaluating the number of needed injections over a 18 month period in patients with newly diagnosed CRVO.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Stockholm, 11282, Sweden
Forty patients diagnosed with a new central retinal vein occlusion (CRVO) of a maximum duration of 6 months will be recruited to the study. Patients will be randomized 1:1 to treatment with aflibercept ot ranibizumab.
all patients will receive 3 initial monthly injections. There after injections will be given att every visit according to a treat and extend schedule. If no macular edema is seen on the Ocular coherent tomography (OCT) examination the next treatment will be after 6 weeks. If the macula is dry after 6 weeks a new injection is given and the next visit is scheduled for another 8 weeks. If edema is seen on the OCT after 8 weeks the time to next injection is reduced to 6 weeks. Patients cannot receive an injection more often than every 4 weeks. All patients will receive an injection at least every 12 weeks.
Primary outcome: the number of needed injections over a 18 month period comparing ranibizumab and aflibercept.
Secondary outcome: Change in visual acuity, change in macular thickness. A subgroup of patients will also be evaluated with OCT angiography. A possible relationship between the Visual acuity and the foveal avascular zone will be evaluated.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Aflibercept injection is given at every visit. Time to next treatment according to presence of macular edema
Other names: Eylea
Ranibizumab injection is given at every visit. Time to next treatment according to presence of macular edema
Other names: Lucentis
Time frame: 18 months
Time frame: 18 months
Change in visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) letters
Time frame: 18 months
Change in macular thickness measured by Cirrus OCT (µm)
Anders Kvanta
Other
Randomized Trial Comparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With Central Retinal Vein Occlusion With a Treat and Extend Algorithm
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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