Evaluating the effects of adding curcumin to bevacizumab for treating macular edema
Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin in Diabetic Macular Edema
This study is testing if adding curcumin to the standard eye injection treatment for macular edema can help improve vision and reduce swelling in people with diabetic retinopathy.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Isfahan University of Medical Sciences Academic / other |
| Drugs / interventions | bevacizumab |
| Locations | 1 site (Isfahan, Isfahan University of Medical Sciences) |
| Trial ID | NCT06595355 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of combining oral curcumin with intravitreal injections of bevacizumab in patients suffering from central macular edema due to diabetic retinopathy. It is a randomized, controlled, and blinded study where participants are divided into two groups: one receiving bevacizumab with curcumin and the other receiving bevacizumab with a placebo. The primary outcomes include measuring the central macular thickness and volume, while the secondary outcome focuses on assessing the best corrected visual acuity of the patients. The study aims to determine if the addition of curcumin enhances the treatment effects of bevacizumab.
Who should consider this trial
Good fit: Ideal candidates are diabetic patients with center-involving macular edema and a central macular thickness greater than 300 microns.
Not a fit: Patients with other retinal diseases, proliferative diabetic retinopathy, or those who have had recent ocular surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve visual outcomes for patients with diabetic macular edema.
How similar studies have performed: While the combination of curcumin with standard treatments is a novel approach, previous studies have shown promising results with curcumin in other contexts, but this specific combination is less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Isfahan, Isfahan University of Medical Sciences
- Mohsen Pourazizi — Isfahan, Isfahan University of Medical Sciences, Iran (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.