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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal bevacizumab (Avastin) | Active Comparator | Dosage: 1.25 mg/0.05 ml Frequency: 3 consecutive injections every 4 weeks |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal injection of bevacizumab (Avastin) | Drug |
| ||
| Intravitreal injection of fasudil and bevacizumab (Avastin) |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity | Snellen E-chart | 6 months |
| central macular thickness | spectral domain optical coherence tomography (SD OCT) | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Status of macular perfusion | Heidelberg fluorescein angiogram (HRA II) | 6 months |
| intraocular inflammation | clinical examination | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tehran | Iran |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Drug |
intravitreal injections of bevacizumab and fasudil are performed at two different sites (superior temporal and inferior temporal quadrants respectively) |
|
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |