Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823081
• Other study ID #: 91128
• Status: Completed
• Phase: Phase 3
• First received: March 21, 2013
• Last updated: May 10, 2017
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: July 2012
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: December 2015
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Intravitreal injection of bevacizumab (Avastin)

• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity	Snellen E-chart	6 months
Primary	central macular thickness	spectral domain optical coherence tomography (SD OCT)	6 months
Secondary	Status of macular perfusion	Heidelberg fluorescein angiogram (HRA II)	6 months
Secondary	intraocular inflammation	clinical examination	6 months