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In this randomized clinical trial, 100 eyes with nonproliferative diabetic retinopathy will be included and divided randomly into 2 groups: Intravitreal Bevacizumab group (50 eyes) that receive 6 bimonthly intravitreal bevacizumab, and control group (50 eyes) that undergo regular follow-up for Diabetic Retinopathy. Diabetic macular edema (DME) will be treated independently in all groups by intravitreal bevacizumab. Primary outcome will be the percentage of patients with progression of 2 or more stages through international diabetic retinopathy staging. The secondary measures will be changes in best corrected visual acuity (BCVA) and central macular thickness (CMT), and number of examinations and injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal Bevacizumab IVB group | Active Comparator |
| |
| undergo regular follow-up for Diabetic Retinopathy | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal Bevacizumab IVB | Drug | Intravitreal Bevacizumab IVB group (50 eyes) that receive 6 bimonthly IVBs within a period of 10 months following the enrollment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with equal or more than 2 stages of progression in diabetic retinopathy staging | Multiple fundus photographs interpreted by a single vitreoretinal surgeon who is blind to the study groups | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity | Best corrected visual acuity based on ETDRS letter scale and logMAR | 12 months |
| Central retinal thickness | Central retinal thickness according to macular ocular coherence tomography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Homayon Nikkhah, MD | Contact | 009822591616 | labbafi@hotmail.com |
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| Follow-up with regular examination for determination of DR progression | Other | regular examination for determination of DR progression |
|
| 12 months |
| Number of visits | Number of visits in each time point | 12 months |