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Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema

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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

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.


Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Intravitreal injection of bevacizumab (Avastin) Drug: Intravitreal injection of fasudil and bevacizumab (Avastin) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : January 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Bevacizumab

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)




Primary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: 6 months ]
    Snellen E-chart

  2. central macular thickness [ Time Frame: 6 months ]
    spectral domain optical coherence tomography (SD OCT)


Secondary Outcome Measures :
  1. Status of macular perfusion [ Time Frame: 6 months ]
    Heidelberg fluorescein angiogram (HRA II)

  2. intraocular inflammation [ Time Frame: 6 months ]
    clinical examination



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823081


Locations
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Iran, Islamic Republic of
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences

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Responsible Party: Zahra Rabbani Khah, Clinical Professor, Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01823081     History of Changes
Other Study ID Numbers: 91128
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: July 2012
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Fasudil
1-(5-Isoquinolinesulfonyl)-2-Methylpiperazine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Protein Kinase Inhibitors
Enzyme Inhibitors