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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

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ClinicalTrials.gov Identifier: NCT03391219
Recruitment Status : Unknown
Verified December 2017 by Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

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.


Condition or disease Intervention/treatment Phase
Retinal Vein Occlusion Drug: injection bevacizumab Drug: injection Combined Bevacizumab and Fasudil Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Combined Intravitreal Injection of Bevacizumab and Fasudil Versus Bevacizumab Alone for Macular Edema Secondary to Retinal Vein Occlusion in Previously Treated Patients.
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Bevacizumab

Arm Intervention/treatment
Active Comparator: intravitreal Bevacizumab Drug: injection bevacizumab
1.25 mg/0.05 cc bevacizumab

Active Comparator: intravitreal Bavacizumab and Fasudil Drug: injection Combined Bevacizumab and Fasudil
1.25 mg/0.05 cc bevacizumab and 0.15mg/0.05 cc fasudil




Primary Outcome Measures :
  1. Measure Macular Thickness [ Time Frame: 9 month ]
    Optical Coherence Tomography


Secondary Outcome Measures :
  1. Measure Visual acuity [ Time Frame: 9 month ]
    Snellen chart



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391219


Contacts
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Contact: Ramin Noorinia, MD 982122591616 labbafi@hotmail.com

Locations
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Iran, Islamic Republic of
Ophthalmic Research Center Recruiting
Tehran, Iran, Islamic Republic of
Contact: Ramin Noorinia, MD    009822591616    labbafi@hotmail.com   
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
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Responsible Party: Zahra Rabbani Khah, Head of ophthalmic research center, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03391219    
Other Study ID Numbers: 96299
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Edema
Retinal Vein Occlusion
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Bevacizumab
Fasudil
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Protein Kinase Inhibitors
Enzyme Inhibitors