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

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

Recruiting
40 years and older
All
Phase 2/3

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Overview

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

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

Study details
    Diabetic Macular Edema
    Macular Edema
    Retinal Neovascularization

NCT06595355

Isfahan University of Medical Sciences

21 August 2025

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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