Overview

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

Status:
Unknown status
Trial end date:
2018-10-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Shahid Beheshti University of Medical Sciences
Treatments:
Bevacizumab
Fasudil
Criteria
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