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

NCT03391219 | Unknown Phase 2

• 1 other identifier: 96299
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

• Measure Macular Thickness

  Optical Coherence Tomography

  9 month

Secondary Outcomes (1)

• Measure Visual acuity

  9 month

Study Arms (2)

intravitreal Bevacizumab

ACTIVE COMPARATOR

Drug: injection bevacizumab

intravitreal Bavacizumab and Fasudil

ACTIVE COMPARATOR

Drug: injection Combined Bevacizumab and Fasudil

Interventions

injection bevacizumab DRUG

1.25 mg/0.05 cc bevacizumab

intravitreal Bevacizumab

injection Combined Bevacizumab and Fasudil DRUG

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

intravitreal Bavacizumab and Fasudil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Ophthalmic Research Center

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

fasudil

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ramin Noorinia, MD

CONTACT

982122591616; labbafi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of ophthalmic research center

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: January 5, 2018
• Study Start: January 1, 2018
• Primary Completion: April 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 5, 2018

Record last verified: 2017-12

Locations

IR (1)