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Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Intravitreal injection of bevacizumab (Avastin)
Intravitreal injection of fasudil and bevacizumab (Avastin)
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intravitreal bevacizumab (Avastin)

Combined intravitreal fasudil and bevacizumab (Avastin)

Arm Description

Dosage: 1.25 mg/0.05 ml Frequency: 3 consecutive injections every 4 weeks

Dosage: bevacizumab 1.25 mg/0.05 ml + fasudil 0.025mg/0.05ml Frequency: 3 consecutive injections every 4 weeks

Outcomes

Primary Outcome Measures

Best corrected visual acuity
Snellen E-chart
central macular thickness
spectral domain optical coherence tomography (SD OCT)

Secondary Outcome Measures

Status of macular perfusion
Heidelberg fluorescein angiogram (HRA II)
intraocular inflammation
clinical examination

Full Information

First Posted
March 21, 2013
Last Updated
May 10, 2017
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01823081
Brief Title
Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2013 (Actual)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravitreal bevacizumab (Avastin)
Arm Type
Active Comparator
Arm Description
Dosage: 1.25 mg/0.05 ml Frequency: 3 consecutive injections every 4 weeks
Arm Title
Combined intravitreal fasudil and bevacizumab (Avastin)
Arm Type
Active Comparator
Arm Description
Dosage: bevacizumab 1.25 mg/0.05 ml + fasudil 0.025mg/0.05ml Frequency: 3 consecutive injections every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Intravitreal injection of bevacizumab (Avastin)
Intervention Type
Drug
Intervention Name(s)
Intravitreal injection of fasudil and bevacizumab (Avastin)
Intervention Description
intravitreal injections of bevacizumab and fasudil are performed at two different sites (superior temporal and inferior temporal quadrants respectively)
Primary Outcome Measure Information:
Title
Best corrected visual acuity
Description
Snellen E-chart
Time Frame
6 months
Title
central macular thickness
Description
spectral domain optical coherence tomography (SD OCT)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Status of macular perfusion
Description
Heidelberg fluorescein angiogram (HRA II)
Time Frame
6 months
Title
intraocular inflammation
Description
clinical examination
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema

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