Diabetic Macular Edema, Macular Edema, Retinal Neovascularization
Conditions
Keywords
macular edema, diabetic macular edema, central macular edema, bevacizumab, Diabetic Retinopathy, Retinal Neovascularization
Brief summary
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.
Interventions
DRUGbevacizumab with oral curcumin
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).
DRUGbevacizumab with oral placebo
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).
Sponsors
Isfahan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
1. Other retinal diseases except for DME and macular edema due to other causes including uveitis, epiretinal membrane, central retinal vein occlusion, and... 2. Existence of proliferative diabetic retinopathy and patients with a history of vitrectomy 3. Patients with glaucoma, vitreous hemorrhage, age-related macular degeneration (ARMD) 4. Media opacities that limit the interpretation of diagnostic tests 5. Surgery or procedure 3 months before starting treatment 6. Pregnancy or breastfeeding 7. History of allergy to curcumin 8. Use of warfarin 9. Changing the patient's clinical diagnosis or the need for surgical interventions in the course of the disease 10. Change in the patient's general health condition 11. Absence of patient referrals 12. Lack of consent to continue treatment and follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| central macular thickness (CMT) | 3 months | Changes in central macular thickness (CMT) in patients with oral Curcumin versus patients in the control group |
| central macular volume (CMV) | 3 months | Changes in central macular volume (CMV) in patients with oral Curcumin versus patients in the control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| best visual acuity (BCVA) | 3 months | Changes in best visual acuity (BCVA) in patients with oral Curcumin versus patients in the control group |
Countries
Iran
Outcome results
None listed