NCT06595355 Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin
| NCT ID | NCT06595355 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Isfahan University of Medical Sciences |
| Condition | Diabetic Macular Edema |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2021-10-10 |
| Primary Completion | 2025-09-22 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 52 participants in total. It began in 2021-10-10 with a primary completion date of 2025-09-22.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT06595355 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Diabetic Macular Edema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06595355 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06595355 currently recruiting?
Yes, NCT06595355 is actively recruiting participants. Visit ClinicalTrials.gov or contact Isfahan University of Medical Sciences to inquire about joining.
Where is the NCT06595355 trial being conducted?
This trial is being conducted at Isfahan, Iran.
Who is sponsoring the NCT06595355 clinical trial?
NCT06595355 is sponsored by Isfahan University of Medical Sciences. The trial plans to enroll 52 participants.