Actively Recruiting
Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin in Diabetic Macular Edema
Led by Isfahan University of Medical Sciences · Updated on 2024-09-19
52
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of adding oral curcumin treatment to intravitreal injections of bevacizumab in patients with diabetic macular edema. This randomized, single-blind clinical trial aims to compare two groups: one receiving bevacizumab plus curcumin, and the other receiving bevacizumab plus a placebo. The primary goals are to assess the central thickness and volume of the macula, while also measuring the best visual acuity as a secondary outcome. The study involves two intervention groups. Both groups receive intravitreal injections of bevacizumab at a standard dose of 1.25 mg/0.05 ml, administered three times at monthly intervals. In the curcumin group, participants also take oral curcumin tablets twice daily at 40 mg each for three months, starting alongside the bevacizumab treatment. The control group takes matching placebo tablets on the same schedule. Participants will be monitored over a three-month period with assessments of macular thickness, macular volume, and visual acuity. These evaluations help determine the effects of the treatments on diabetic macular edema. Safety and treatment response are tracked throughout the study, which is conducted under medical supervision to ensure participant well-being and adherence to the treatment protocol.
CONDITIONS
Brief 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 over 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) not worse than 20/400
- Consent to participate in the study
You will not qualify if you...
- Presence of retinal diseases other than diabetic macular edema and macular edema due to other causes such as uveitis, epiretinal membrane, or central retinal vein occlusion
- Proliferative diabetic retinopathy or history of vitrectomy
- Diagnosis of glaucoma, vitreous hemorrhage, or age-related macular degeneration (ARMD)
- Media opacities that prevent clear interpretation of diagnostic tests
- Surgery or procedure within 3 months before starting treatment
- Pregnancy or breastfeeding
- History of allergy to curcumin
- Use of warfarin
- Changes in clinical diagnosis or need for surgical interventions during the study
- Significant changes in general health condition
- Missing scheduled patient referrals
- Withdrawal of consent to continue treatment and follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive intravitreal injections of bevacizumab once a month for three months and take oral curcumin or placebo tablets twice daily for three months.
3 intravitreal injection visits and daily oral medication
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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