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This study is aimed to compare the effect of combined intravitreal Bevacizumab and Fasudil injection with Bevacizumab only injection in patients with persistant macular edema secondary to ratinal vein occlusion.
Methods:
In this study patients with retinal vein occlusion patient who had at least three or more intravitreal AntiVEGF injection with persistence of macular edema at funduscopic examination is recruited. The eligible patients in randomized in two groups "Bevacizumab" and "Bavacizumab + Fasudil" and in injected intravitreally for 3 times monthly. In "Bevacizumab+Fasudil" group patients receive two injections at each session Bavacizumab and Fasudil. In "Bevacizumab" group patients receive only Bevacizumab. The patients are followed for 6 months and central macular thickness and visual acuity is measured at baseline and monthly for 6 month. Baseline ancillary exams include Fluorescein Angiography and OCT-Angiography which is performed at the final exam as well. Patients needing any therapeutic intervention is addressed during the 6 month follow up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravitreal Bevacizumab | Active Comparator |
| |
| intravitreal Bavacizumab and Fasudil | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injection bevacizumab | Drug | 1.25 mg/0.05 cc bevacizumab |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Measure Macular Thickness | Optical Coherence Tomography | 9 month |
| Measure | Description | Time Frame |
|---|---|---|
| Measure Visual acuity | Snellen chart | 9 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ramin Noorinia, MD | Contact | 982122591616 | labbafi@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Research Center | Recruiting | Tehran | Iran |
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| injection Combined Bevacizumab and Fasudil |
| Drug |
1.25 mg/0.05 cc bevacizumab and 0.15mg/0.05 cc fasudil |
|
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C049347 | fasudil |
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