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

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Retinal Vein Occlusion

Treatments: Drug: injection Combined Bevacizumab and Fasudil; Drug: injection bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT03391219

96299

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

intravitreal Bevacizumab

Active Comparator group

Treatment:

Drug: injection bevacizumab

intravitreal Bavacizumab and Fasudil

Active Comparator group

Treatment:

Drug: injection Combined Bevacizumab and Fasudil