Eylea and Lucentis for Macular Edema in Branch Retinal Vein Occlusion

Study Overview
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Brief Summary
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Comparing time to recurrence of macular edema after an initial loading dose of at least three monthly anti VEGF injections (aflibercept or ranibizumab) for macular edema in BRVO.

Detailed Description
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One hundred and ten patients with macular edema (ME) secondary to BRVO are randomized (1:1) to treatment with intravitreal injections of aflibercept or ranibizumab. An initial loading dose of at least three monthly injections is given in the study eye until the ME is resolved. Then patients are observed at regular intervals, initially every four weeks until study completion. Total follow-up time is nine months from baseline to completion. If ME recurs, patients are treated according to a treat-and-extend algorithm. At every visit, visual acuity (VA) is measured with an ETDRS chart at 4 m. The fundus is examined by indirect ophthalmoscopy and by optical coherence tomography (OCT). Macular ischemia is evaluated with OCT angiography (OCT-A), visual field status with computerised perimetry and retinal sensitivity with microperimetry. Choroidal thickness is evaluated with enhanced depth imaging (EDI) OCT. Vision related quality of life (QoL) with NEI VFQ25.

Official Title
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A Randomized Trial Comparing Treatment With Aflibercept and Ranibizuamab for Macular Edema After Branch Retinal Vein Occlusion

Conditions
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Branch Retinal Vein Occlusion With Macular Edema

Intervention / Treatment
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* Drug: Aflibercept Injection [Eylea]
* Drug: Ranibizumab Injection [Lucentis]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BRVO naïve patients, disease duration 1-6 months, BCVA 23-73 ETDRS letters (20/40-20/320), macula edema with intraretinal cysts and CRT > 300 micrometers (Cirrus) Exclusion Criteria: BRVO with neovascular component, intraocular surgery during the previous 3 months, earlier vitreoretinal surgery, vascular retinopathy of other cause, intraocular infection/inflammation, myocardial infarction och cerebrovascular 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 is given monthly (at least 3 times) until resolution of macular edema after which the patient is observed monthly. If there is recurrence of macula edema, the patient is given aflibercept according to a treat-and-extend regimen. | Drug: Aflibercept Injection [Eylea]<br>* Intravitreal injection is given as described in the arm description<br>* Other names: Eylea;|
| Active Comparator: Ranibizumab<br>Ranibizumab is given monthly (at least 3 times) until resolution of macular edema after which the patient is observed monthly. If there is recurrence of macula edema, the patient is given ranibizumab according to a treat-and-extend regimen. | Drug: Ranibizumab Injection [Lucentis]<br>* Intravitreal injection is given as described in the arm description<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in time to recurrence of macular edema | Time, in weeks, from completion of loading dose to first recurrence of macular edema. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the number of patients without ME in each treatment arm at one month after the first injection | The number of patients without macular edema at one month after the 1st injection in each treatment arm are compared | 1 month | 
| Comparison of the number of injections needed in each treatment arm to resolve ME | The number of injections needed for macular edema to resolve in each treatment arm are compared | 9 months | 
| Occurrence and evolution of macular ischemia over time | Area of non perfusion measured by OCT-angiography | 9 moths | 
| Correlation between choroidal thickness and recurrence of ME and with non response to the treatment drugs. |  | 9 months | 
| Correlation of vision related QoL in patients with a good visual acuity and findings on visual fields, retinal sensitivity, macular ischemia and near VA. |  | 9 months |