Back to results

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

Primary Purpose

Retinal Vein Occlusion

Status

Unknown status

Phase

Phase 2

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

injection bevacizumab

injection Combined Bevacizumab and Fasudil

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Ophthalmic Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

intravitreal Bevacizumab

intravitreal Bavacizumab and Fasudil

Arm Description

Outcomes

Primary Outcome Measures

Measure Macular Thickness

Optical Coherence Tomography

Secondary Outcome Measures

Measure Visual acuity

Snellen chart

Full Information

NCT ID

NCT03391219

First Posted

December 19, 2017

Last Updated

January 4, 2018

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03391219

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 2018 (Anticipated)

Primary Completion Date

April 2018 (Anticipated)

Study Completion Date

October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Vein Occlusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

intravitreal Bevacizumab

Arm Type

Active Comparator

Arm Title

intravitreal Bavacizumab and Fasudil

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

injection bevacizumab

Intervention Description

1.25 mg/0.05 cc bevacizumab

Intervention Type

Drug

Intervention Name(s)

injection Combined Bevacizumab and Fasudil

Intervention Description

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

Primary Outcome Measure Information:

Title

Measure Macular Thickness

Description

Optical Coherence Tomography

Time Frame

9 month

Secondary Outcome Measure Information:

Title

Measure Visual acuity

Description

Snellen chart

Time Frame

9 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ramin Noorinia, MD

Phone

982122591616

labbafi@hotmail.com

Facility Information:

Facility Name

Ophthalmic Research Center

City

Tehran

Country

Iran, Islamic Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ramin Noorinia, MD

Phone

009822591616

labbafi@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs