Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01823081

Enrollment

Registered

2013-04-04

Start date

2013-01-31

Completion date

2015-12-31

Last updated

2017-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

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.

Interventions

DRUGIntravitreal injection of bevacizumab (Avastin)

DRUGIntravitreal 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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Best corrected visual acuity	6 months	Snellen E-chart
central macular thickness	6 months	spectral domain optical coherence tomography (SD OCT)

Secondary

Measure	Time frame	Description
Status of macular perfusion	6 months	Heidelberg fluorescein angiogram (HRA II)
intraocular inflammation	6 months	clinical examination

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026