Comparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With CRVO With a Treat& Extend Regimen

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Trial Comparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With Central Retinal Vein Occlusion With a Treat and Extend Algorithm

Conditions
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Central Retinal Vein Occlusion

Intervention / Treatment
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* Drug: Aflibercept
* Drug: Ranibizumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aflibercept<br>Aflibercept injection is given at every visit. Time to next treatment according to presence of macular edema | Drug: Aflibercept<br>* Aflibercept injection is given at every visit. Time to next treatment according to presence of macular edema<br>* Other names: Eylea;|
| Active Comparator: Ranibizumab<br>Ranibizumab injection is given at every visit. Time to next treatment according to presence of macular edema | Drug: Ranibizumab<br>* Ranibizumab injection is given at every visit. Time to next treatment according to presence of macular edema<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of needed injections over a 18 month period comparing ranibizumab and aflibercept. |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual acuity | Change in visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study) letters | 18 months | 
| Change in macular thickness | Change in macular thickness measured by Cirrus OCT (µm) | 18 months |