Branch Retinal Vein Occlusion (BRVO) Treatment With Bevacizumab and Dexamethasone or Bevacizumab Only.

Study Overview
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Brief Summary
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The aim of this study is to evaluate the visual outcome and prognostic factors after intraocular injections of Bevacizumab or combination of Bevacizumab And Dexamethasone under pro re nata treatment regimen for Branch Retinal Vein Occlusion (BRVO) patients.

Detailed Description
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The aim of this study is to evaluate the clinical outcome after intraocular injections of Bevacizumab or combination of Bevacizumab and Dexamethasone under pro re nata treatment regimen for the patients with Branch Retinal Vein Occlusion (BRVO) patients. Mean change of logarithm of the minimal angle of resolution (logMAR) visual acuity (VA), central foveal thickness (CFT), contrast sensitivity (CS) as well as predictive factors including best-corrected visual acuity (BCVA), vision related questionnaires and various other ocular parameters will be assessed.

Official Title
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Study on Branch Retinal Vein Occlusion Patients Receiving Bevacizumab and Dexamethasone or Bevacizumab Only on Naive Eyes.

Conditions
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Branch Retinal Vein Occlusion

Intervention / Treatment
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* Drug: Bevacizumab Ophthalmic and Intravitreal Dexamethasone
* Drug: Bevacizumab Ophthalmic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent must be obtained before any study assessment is performed Diagnosis of visual impairment exclusively due to ME secondary to BRVO BCVA score at Screening and Baseline between 10/40 (0.5) to 20/400 (0.05) on the Snellen chart. Central foveal thickness (CFT) ≥ 300 µm Naive Eyes Exclusion Criteria: Pregnant or nursing (lactating) women Stroke or myocardial infarction less than 3 months before Screening Uncontrolled blood pressure defined as systolic value of >160 mm Hg or diastolic value of >100 mm Hg at Screening or Baseline. Any active periocular or ocular infection or inflammation at Screening or Baseline in either eye Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before Baseline in either eye Neovascularization of the iris or neovascular glaucoma in the study eye Use of any systemic or ocular antivascular endothelial growth factor (anti-VEGF) drugs within 6 months before Baseline Panretinal laser photocoagulation performed, anticipated or scheduled in the study eye Focal or grid laser photocoagulation in the study eye Use of intra- or periocular corticosteroids (including sub-Tenon) or ocular anti-VEGF treatment within 3 months before Screening in the study eye Any use of intraocular corticosteroid implants (eg, dexamethasone [Ozurdex®], fluocinolone acetonide [Iluvien®]) in the study eye

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BRVO: Bevacizumab and intravitreal Dexamethasone<br>Participants with BRVO will receive a combination of Bevacizumab and intravitreal Dexamethasone. | Drug: Bevacizumab Ophthalmic and Intravitreal Dexamethasone<br>* Pro re nata patients with BRVO will initially receive Bevacizumab and intravitreal Dexamethasone. And then depending on their clinical status of BRVO, Bevacizumab will be injected.<br>* Other names: Ozurdex®;|
| Active Comparator: BRVO: Bevacizumab<br>Participants with BRVO will receive Bevacizumab only. | Drug: Bevacizumab Ophthalmic<br>* Pro re nata patients with BRVO will receive Bevacizumab. And then depending on their clinical status of BRVO, Bevacizumab will be injected.<br>* Other names: Avastin®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in monocular BCVA in the treatment eye | Monocular BCVA in the treatment eye is assessed by using ETDRS visual acuity charts at 4 meters is assessed and compared. | Baseline, 1 week, 1month, 2 months, 3 months, and 6 months. | 
| Mean change in binocular BCVA | Binocular BCVA is assessed by using ETDRS visual acuity charts at 4 meters is assessed and compared. | Baseline, 1 week, 1month, 2 months, 3 months, and 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in central subfield retinal thickness | Mean change in central subfield retinal thickness in the study eye, as determined by spectral domain optical coherence tomography (OCT) is assessed and compared. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. | 
| Change in Humphrey 10-2 visual field in the treatment eye | Mean deviation (MD) of the Humphrey 10-2 visual field is assessed by a Humphrey 10-2 visual field test and compared. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. | 
| Number of Bevacizumab. Treatments | Number of injections provided to the patients during the 6 month period. | Day 1 through Month 6 | 
| Mean change in NEI VFQ25 | Scores from NEI VFQ25 questionnaire is assessed and compared. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. | 
| Mean change in EQ-5D 5L | Scores from EQ-5D 5L questionnaire is assessed and compared. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. | 
| Mean change in VisQoL scores | Scores from VisQoL questionnaire is assessed and compared. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. | 
| Mean change in wavefront aberrations | Mean deviation (MD) of wavefront aberrations is assessed by Nidek OPD Scan III and compared. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. | 
| Mean change in ocular surface and tear-film | Mean deviation (MD) of ocular surface and tear-film parameters is assessed by Oculus Keratographer test and compared. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. | 
| Mean change in vessel density | Mean deviation (MD) of vessel density is assessed by Spectralis OCT2, Heidelberg-Engineering test and compared. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. | 
| Side effects | Side effects are measured by a review of the participant's medical and ophthalmic history. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. | 
| People meeting driving standards | Percentage (%) of people meeting driving standards is assessed by an Esterman binocular visual field test and compared. | Baseline, 1 day, 1 week, 1month, 2 months, 3 months, and 6 months. |