Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema

NCT01823081 | Completed Phase 3 DMC

• 1 other identifier: 91128
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

• Best corrected visual acuity

  Snellen E-chart

  6 months

• central macular thickness

  spectral domain optical coherence tomography (SD OCT)

  6 months

Secondary Outcomes (2)

• Status of macular perfusion

  6 months

• intraocular inflammation

  6 months

Study Arms (2)

Intravitreal bevacizumab (Avastin)

ACTIVE COMPARATOR

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

Drug: Intravitreal injection of bevacizumab (Avastin)

Combined intravitreal fasudil and bevacizumab (Avastin)

ACTIVE COMPARATOR

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)

Interventions

Intravitreal injection of bevacizumab (Avastin) DRUG

Intravitreal bevacizumab (Avastin)

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)

Combined intravitreal fasudil and bevacizumab (Avastin)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Unknown Facility

Tehran, Iran

Location

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Ophthalmic Research Center

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: April 4, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2015
• Last Updated: May 11, 2017

Record last verified: 2012-07

Locations

IR (1)