Comparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With CRVO With a Treat& Extend Regimen
Primary Purpose
Central Retinal Vein Occlusion
Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Aflibercept
Ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Central Retinal Vein Occlusion
Eligibility Criteria
Inclusion Criteria:
- CRVO - naive patients, disease duration maximum 12 months, Best corrected visual acuity : 23-73 letters (20/40 - 20/320), Macular edema > 300 μm (Cirrus)
Exclusion Criteria:
- 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.
Sites / Locations
- St Eriks Eye Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Aflibercept
Ranibizumab
Arm Description
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
Outcomes
Primary Outcome Measures
The number of needed injections over a 18 month period comparing ranibizumab and aflibercept.
Secondary Outcome Measures
Change in visual acuity
Change in visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) letters
Change in macular thickness
Change in macular thickness measured by Cirrus OCT (µm)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02274259
Brief Title
Comparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With CRVO With a Treat& Extend Regimen
Official Title
Randomized Trial Comparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With Central Retinal Vein Occlusion With a Treat and Extend Algorithm
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anders Kvanta
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Vein Occlusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aflibercept
Arm Type
Active Comparator
Arm Description
Aflibercept injection is given at every visit. Time to next treatment according to presence of macular edema
Arm Title
Ranibizumab
Arm Type
Active Comparator
Arm Description
Ranibizumab injection is given at every visit. Time to next treatment according to presence of macular edema
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea
Intervention Description
Aflibercept injection is given at every visit. Time to next treatment according to presence of macular edema
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Ranibizumab injection is given at every visit. Time to next treatment according to presence of macular edema
Primary Outcome Measure Information:
Title
The number of needed injections over a 18 month period comparing ranibizumab and aflibercept.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Change in visual acuity
Description
Change in visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) letters
Time Frame
18 months
Title
Change in macular thickness
Description
Change in macular thickness measured by Cirrus OCT (µm)
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CRVO - naive patients, disease duration maximum 12 months, Best corrected visual acuity : 23-73 letters (20/40 - 20/320), Macular edema > 300 μm (Cirrus)
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofie Westman
Organizational Affiliation
Study coordinator
Official's Role
Study Chair
Facility Information:
Facility Name
St Eriks Eye Hospital
City
Stockholm
ZIP/Postal Code
11282
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
27409478
Citation
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.
Results Reference
derived
Learn more about this trial
Comparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With CRVO With a Treat& Extend Regimen
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