Comparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With CRVO With a Treat& Extend Regimen
Randomized Trial Comparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With Central Retinal Vein Occlusion With a Treat and Extend Algorithm
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2014
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 2, 2014
CompletedFirst Posted
Study publicly available on registry
October 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedDecember 4, 2020
December 1, 2020
8 months
October 2, 2014
December 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The number of needed injections over a 18 month period comparing ranibizumab and aflibercept.
18 months
Secondary Outcomes (2)
Change in visual acuity
18 months
Change in macular thickness
18 months
Study Arms (2)
Aflibercept
ACTIVE COMPARATORAflibercept injection is given at every visit. Time to next treatment according to presence of macular edema
Ranibizumab
ACTIVE COMPARATORRanibizumab injection is given at every visit. Time to next treatment according to presence of macular edema
Interventions
Aflibercept injection is given at every visit. Time to next treatment according to presence of macular edema
Ranibizumab injection is given at every visit. Time to next treatment according to presence of macular edema
Eligibility Criteria
You may qualify if:
- CRVO - naive patients, disease duration maximum 12 months, Best corrected visual acuity : 23-73 letters (20/40 - 20/320), Macular edema \> 300 μm (Cirrus)
You may not qualify if:
- Neovascular Glaucoma Any previous treatment for CRVO. Intraocular surgery during the previous 3 months. Vascular retinopathy of other causes. Glaucoma with uncontrolled IOP (intra ocular pressure) Myocardial infarction or stroke during the last 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anders Kvantalead
Study Sites (1)
St Eriks Eye Hospital
Stockholm, 11282, Sweden
Related Publications (1)
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.
PMID: 27409478DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sofie Westman
Study coordinator
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 2, 2014
First Posted
October 24, 2014
Study Start
October 1, 2014
Primary Completion
June 1, 2015
Study Completion
December 1, 2016
Last Updated
December 4, 2020
Record last verified: 2020-12