Actively Recruiting
Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin
Led by Isfahan University of Medical Sciences · Updated on 2024-09-19
52
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with center-involving macular edema with macular center thickness more than 300 microns on OCT
- No intravitreal bevacizumab injection in the last 3 months
- No intravitreal corticosteroid injection in the last 6 months
- Best corrected visual acuity (BCVA) of 20/400 or better
- Consent to participate in the study
You will not qualify if you...
- Other retinal diseases besides diabetic macular edema, including uveitis, epiretinal membrane, and central retinal vein occlusion
- Presence of proliferative diabetic retinopathy or history of vitrectomy
- Glaucoma, vitreous hemorrhage, or age-related macular degeneration
- Media opacities limiting diagnostic test interpretation
- Surgery or procedure within 3 months before starting treatment
- Pregnancy or breastfeeding
- Allergy to curcumin
- Use of warfarin
- Change in clinical diagnosis or need for surgical interventions during the study
- Change in general health condition
- Missing patient referrals
- Lack of consent to continue treatment and follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mohsen Pourazizi
Isfahan, Isfahan University of Medical Sciences, Iran, 8174673461
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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