- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Tehran, Iran, Islamic Republic of
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Intravitreal bevacizumab (Avastin)
Dosage: 1.25 mg/0.05 ml Frequency: 3 consecutive injections every 4 weeks
|
|
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
|
intravitreal injections of bevacizumab and fasudil are performed at two different sites (superior temporal and inferior temporal quadrants respectively)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Best corrected visual acuity
Time Frame: 6 months
|
Snellen E-chart
|
6 months
|
central macular thickness
Time Frame: 6 months
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spectral domain optical coherence tomography (SD OCT)
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Status of macular perfusion
Time Frame: 6 months
|
Heidelberg fluorescein angiogram (HRA II)
|
6 months
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intraocular inflammation
Time Frame: 6 months
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clinical examination
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6 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Macular Edema
- Edema
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Membrane Transport Modulators
- Protein Kinase Inhibitors
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Bevacizumab
- Fasudil
Other Study ID Numbers
- 91128
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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