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The purpose of this study is to evaluate the effectiveness of adding curcumin oral treatment to bevacizumab intravitreal injection in patients with central macular edema.
A blind study and a randomized and controlled clinical trial are conducted on diabetic patients with macular edema. The patients are divided into two intervention groups (bevacizumab + curcumin) and control (bevacizumab + placebo).
The evaluation of the central thickness of the macula and the evaluation of the central volume of the macula are the primary goals and the evaluation of the best visual acuity of the patient is the secondary goal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case: Intravitreal injection of bevacizumab with oral curcumin | Experimental | Intravitreal injection of bevacizumab with oral curcumin Inclusion criteria: Patients with center-involving macular edema with macular center thickness of more than 300 microns in OCT 2-Patients who did not receive intravitreal bevacizumab in the last 3 months and intravitreal corticosteroids in the previous 6 months. 3- The amount of BCVA should not be <20/400. 4-Consent to participate in the study |
|
| Control: Intravitreal injection of bevacizumab with oral placebo | Placebo Comparator | Intravitreal injection of bevacizumab with oral placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab with oral curcumin | Drug | According to the recommendation of the American Association of Ophthalmologists, intravitreal injection of bevacizumab with a standard dose of 1.25mg/0.05ml in each group will be performed three times consecutively at one-month intervals. In the simultaneous intervention group, patients will take daily curcumin tablets (sinacurcumin product) at a dose of 40 mg twice a day for three months (at the same time as the start of bevacizumab intravitreal injection treatment). |
| Measure | Description | Time Frame |
|---|---|---|
| central macular thickness (CMT) | Changes in central macular thickness (CMT) in patients with oral Curcumin versus patients in the control group | 3 months |
| central macular volume (CMV) | Changes in central macular volume (CMV) in patients with oral Curcumin versus patients in the control group | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| best visual acuity (BCVA) | Changes in best visual acuity (BCVA) in patients with oral Curcumin versus patients in the control group | 3 months |
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Inclusion Criteria:
Patients with center-involving macular edema with macular center thickness more than 300 microns in OCT 2-Patients who did not receive intravitreal bevacizumab in the last 3 months and intravitreal corticosteroids in the last 6 months.
3- The amount of BCVA should not be <20/400. 4-Consent to participate in the study
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mohsen Pourazizi | Recruiting | Isfahan | Isfahan University of Medical Sciences | 8174673461 | Iran |
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|
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| bevacizumab with oral placebo | Drug | Intravitreal injection of bevacizumab with a standard dose of 1.25mg/0.05ml in each group will be performed three times consecutively at one-month intervals. In the control group, patients will be taking daily placebo tablets twice a day for three months (at the same time as the start of bevacizumab intravitreal injection treatment). |
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|
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| D015861 | Retinal Neovascularization |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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