Comparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With CRVO With a Treat& Extend Regimen
NCT ID: NCT02274259
Last Updated: 2020-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2014-10-31
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Aflibercept
Aflibercept injection is given at every visit. Time to next treatment according to presence of macular edema
Aflibercept
Aflibercept injection is given at every visit. Time to next treatment according to presence of macular edema
Ranibizumab
Ranibizumab injection is given at every visit. Time to next treatment according to presence of macular edema
Ranibizumab
Ranibizumab injection is given at every visit. Time to next treatment according to presence of macular edema
Interventions
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Aflibercept
Aflibercept injection is given at every visit. Time to next treatment according to presence of macular edema
Ranibizumab
Ranibizumab injection is given at every visit. Time to next treatment according to presence of macular edema
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Anders Kvanta
OTHER
Responsible Party
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Anders Kvanta
Principal investigator
Principal Investigators
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Sofie Westman
Role: STUDY_CHAIR
Study coordinator
Locations
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St Eriks Eye Hospital
Stockholm, , Sweden
Countries
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References
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Casselholmde Salles M, Kvanta A, Amren U, Epstein D. Optical Coherence Tomography Angiography in Central Retinal Vein Occlusion: Correlation Between the Foveal Avascular Zone and Visual Acuity. Invest Ophthalmol Vis Sci. 2016 Jul 1;57(9):OCT242-6. doi: 10.1167/iovs.15-18819.
Other Identifiers
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690110
Identifier Type: -
Identifier Source: org_study_id