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Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01823081
Recruitment Status : Completed
First Posted : April 4, 2013
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):
Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE March 21, 2013
First Posted Date  ICMJE April 4, 2013
Last Update Posted Date May 11, 2017
Actual Study Start Date  ICMJE January 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2013)
  • Best corrected visual acuity [ Time Frame: 6 months ]
    Snellen E-chart
  • central macular thickness [ Time Frame: 6 months ]
    spectral domain optical coherence tomography (SD OCT)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2013)
  • Status of macular perfusion [ Time Frame: 6 months ]
    Heidelberg fluorescein angiogram (HRA II)
  • intraocular inflammation [ Time Frame: 6 months ]
    clinical examination
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Macular Edema
Intervention  ICMJE
  • Drug: Intravitreal injection of bevacizumab (Avastin)
  • 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)
Study Arms  ICMJE
  • Active Comparator: Intravitreal bevacizumab (Avastin)
    Dosage: 1.25 mg/0.05 ml Frequency: 3 consecutive injections every 4 weeks
    Intervention: 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
    Intervention: Drug: Intravitreal injection of fasudil and bevacizumab (Avastin)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 28, 2013)
74
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01823081
Other Study ID Numbers  ICMJE 91128
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
Study Sponsor  ICMJE Shahid Beheshti University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shahid Beheshti University of Medical Sciences
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP