Status:
RECRUITING
Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin
Lead Sponsor:
Isfahan University of Medical Sciences
Conditions:
Diabetic Macular Edema
Macular Edema
Eligibility:
All Genders
40+ years
Phase:
PHASE2
PHASE3
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 randomiz...
Eligibility Criteria
Inclusion
- 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
- Other retinal diseases except for DME and macular edema due to other causes including uveitis, epiretinal membrane, central retinal vein occlusion, and...
- Existence of proliferative diabetic retinopathy and patients with a history of vitrectomy
- Patients with glaucoma, vitreous hemorrhage, age-related macular degeneration (ARMD)
- Media opacities that limit the interpretation of diagnostic tests
- Surgery or procedure 3 months before starting treatment
- Pregnancy or breastfeeding
- History of allergy to curcumin
- Use of warfarin
- Changing the patient's clinical diagnosis or the need for surgical interventions in the course of the disease
- Change in the patient's general health condition
- Absence of patient referrals
- Lack of consent to continue treatment and follow-up
Key Trial Info
Start Date :
October 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 22 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06595355
Start Date
October 10 2021
End Date
September 22 2025
Last Update
September 19 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mohsen Pourazizi
Isfahan, Isfahan University of Medical Sciences, Iran, 8174673461