Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema

May 10, 2017 updated by: Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

Eligible eyes are randomized to two groups. Group A will receive three intravitreal injections of bevacizumab at 4 week intervals. In group B, three intravitreal injections of combined bevacizumab and fasudil will be performed with the same frequency.

Best corrected visual acuity (BCVA) and central macular thickness (CMT) will be evaluated prior to injections and then every 4 weeks for 6 months. Fluorescein angiography will be performed at baseline and at weeks 12 and 24. The two groups will be compared in terms of BCVA and CMT changes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetic patients with diabetic macular edema (DME) and:
  • Central macula thickness> 250μm
  • Visual acuity < 20/40
  • No active proliferative diabetic retinopathy
  • No history of intravitreal anti-VEGF drug injection or macular laser photocoagulation (MPC) within the past 3 months

Exclusion Criteria:

  • History of vitrectomy
  • History of cataract surgery within the past 6 months
  • History of glaucoma or uveitis
  • Presence of any macular disorder other than DME
  • Presence of traction on the macula
  • Significant media opacity
  • Serum creatinine>3mg/ml

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intravitreal bevacizumab (Avastin)
Dosage: 1.25 mg/0.05 ml Frequency: 3 consecutive injections every 4 weeks
Drug: Intravitreal injection of bevacizumab (Avastin)
ACTIVE_COMPARATOR: Combined intravitreal fasudil and bevacizumab (Avastin)
Dosage: bevacizumab 1.25 mg/0.05 ml + fasudil 0.025mg/0.05ml Frequency: 3 consecutive injections every 4 weeks
Drug: Intravitreal injection of fasudil and bevacizumab (Avastin)
intravitreal injections of bevacizumab and fasudil are performed at two different sites (superior temporal and inferior temporal quadrants respectively)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best corrected visual acuity
Time Frame: 6 months
Snellen E-chart
6 months
central macular thickness
Time Frame: 6 months
spectral domain optical coherence tomography (SD OCT)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Status of macular perfusion
Time Frame: 6 months
Heidelberg fluorescein angiogram (HRA II)
6 months
intraocular inflammation
Time Frame: 6 months
clinical examination
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2013

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

March 21, 2013

First Submitted That Met QC Criteria

March 28, 2013

First Posted (ESTIMATE)

April 4, 2013

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

July 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 91128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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