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Recruiting Phase 2, Phase 3 NCT06595355

NCT06595355 Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin

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Clinical Trial Summary
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

Trial Parameters

Condition Diabetic Macular Edema
Sponsor Isfahan University of Medical Sciences
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 52
Sex ALL
Min Age 40 Years
Max Age N/A
Start Date 2021-10-10
Completion 2025-09-22
Interventions
bevacizumab with oral curcuminbevacizumab with oral placebo

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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

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