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

NCT ID: NCT03391219

Last Updated: 2018-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2018-10-31

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.

Detailed Description

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Conditions

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Retinal Vein Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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intravitreal Bevacizumab

Group Type ACTIVE_COMPARATOR

injection bevacizumab

Intervention Type DRUG

1.25 mg/0.05 cc bevacizumab

intravitreal Bavacizumab and Fasudil

Group Type ACTIVE_COMPARATOR

injection Combined Bevacizumab and Fasudil

Intervention Type DRUG

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

Interventions

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injection bevacizumab

1.25 mg/0.05 cc bevacizumab

Intervention Type DRUG

injection Combined Bevacizumab and Fasudil

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Zahra Rabbani Khah

Head of ophthalmic research center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ophthalmic Research Center

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Ramin Noorinia, MD

Role: CONTACT

982122591616

Facility Contacts

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Ramin Noorinia, MD

Role: primary

009822591616

Other Identifiers

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96299

Identifier Type: -

Identifier Source: org_study_id

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