Combined Intravitreal Injection of Bevacizumab and Fasudil Versus Bevacizumab Alone for Macular Edema Secondary to Retinal Vein Occlusion in Previously Treated Patients

Study Overview
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Brief Summary
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This study is aimed to compare the effect of combined intravitreal Bevacizumab and Fasudil injection with Bevacizumab only injection in patients with persistant macular edema secondary to ratinal vein occlusion. Methods: In this study patients with retinal vein occlusion patient who had at least three or more intravitreal AntiVEGF injection with persistence of macular edema at funduscopic examination is recruited. The eligible patients in randomized in two groups Bevacizumab and Bavacizumab + Fasudil and in injected intravitreally for 3 times monthly. In Bevacizumab+Fasudil group patients receive two injections at each session Bavacizumab and Fasudil. In Bevacizumab group patients receive only Bevacizumab. The patients are followed for 6 months and central macular thickness and visual acuity is measured at baseline and monthly for 6 month. Baseline ancillary exams include Fluorescein Angiography and OCT-Angiography which is performed at the final exam as well. Patients needing any therapeutic intervention is addressed during the 6 month follow up period.

Official Title
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Combined Intravitreal Injection of Bevacizumab and Fasudil Versus Bevacizumab Alone for Macular Edema Secondary to Retinal Vein Occlusion in Previously Treated Patients.

Conditions
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Retinal Vein Occlusion

Intervention / Treatment
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* Drug: injection bevacizumab
* Drug: injection Combined Bevacizumab and Fasudil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Branch retinal vein or central retinal vein occlusion Previous at least 3 intravitreal antiVEGF injection Macular edema in SD-OCT CMT = >250 microns BCVA equal or lesd than 20/40 Exclusion Criteria: Moderate or severe corneal opacity Significant cataract obscuring retinal exam or OCT Glaucoma History of vitreoretinal surgery Diabetic retinopathy Macular disease (AMD,ERM,VMT Kidney or Liver disease Uncontrolled or moderate or severe Anemia Uncontrolled hypertention

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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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intravitreal Bevacizumab<br> | Drug: injection bevacizumab<br>* 1.25 mg/0.05 cc bevacizumab<br>|
| Active Comparator: intravitreal Bavacizumab and Fasudil<br> | Drug: injection Combined Bevacizumab and Fasudil<br>* 1.25 mg/0.05 cc bevacizumab and 0.15mg/0.05 cc fasudil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure Macular Thickness | Optical Coherence Tomography | 9 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure Visual acuity | Snellen chart | 9 month |