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OpenTrials
Completed

NCT Number: NCT01823081

Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema

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.

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Key information

Conditions

Diabetic Macular Edema

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tehran, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravitreal injection of bevacizumab (Avastin)

Drug

Intravitreal injection of fasudil and bevacizumab (Avastin)

Drug

intravitreal injections of bevacizumab and fasudil are performed at two different sites (superior temporal and inferior temporal quadrants respectively)

Primary outcomes

  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 outcomes

  1. Status of macular perfusion

    Time frame: 6 months

    Heidelberg fluorescein angiogram (HRA II)

  2. intraocular inflammation

    Time frame: 6 months

    clinical examination

Sponsors and collaborators

Lead sponsor

Shahid Beheshti University of Medical Sciences

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2015
First posted
Apr 4, 2013
Registry last updated
May 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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