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

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03391219

Enrollment

Registered

2018-01-05

Start date

2018-01-31

Completion date

2018-10-31

Last updated

2018-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinal Vein Occlusion

Brief 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.

Interventions

DRUGinjection bevacizumab

1.25 mg/0.05 cc bevacizumab

DRUGinjection Combined Bevacizumab and Fasudil

1.25 mg/0.05 cc bevacizumab and 0.15mg/0.05 cc fasudil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Measure Macular Thickness	9 month	Optical Coherence Tomography

Secondary

Measure	Time frame	Description
Measure Visual acuity	9 month	Snellen chart

Countries

Iran

Contacts

Primary ContactRamin Noorinia, MD

labbafi@hotmail.com982122591616

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026