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NCT Number: NCT06595355

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

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.

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Key information

Conditions

Diabetic Macular Edema Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Endocrine System Diseases Eye Diseases Macular Degeneration Macular Edema Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Retinal Neovascularization Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Mohsen Pourazizi

Isfahan, Isfahan University of Medical Sciences, 8174673461, Iran

Location status: Recruiting

Location contact

Mohsen Pourazizi, Doctor

CONTACT

[email protected]

+983134452031

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Other retinal diseases except for DME and macular edema due to other causes including uveitis, epiretinal membrane, central retinal vein occlusion, and...
  • Existence of proliferative diabetic retinopathy and patients with a history of vitrectomy
  • Patients with glaucoma, vitreous hemorrhage, age-related macular degeneration (ARMD)
  • Media opacities that limit the interpretation of diagnostic tests
  • Surgery or procedure 3 months before starting treatment
  • Pregnancy or breastfeeding
  • History of allergy to curcumin
  • Use of warfarin
  • Changing the patient's clinical diagnosis or the need for surgical interventions in the course of the disease
  • Change in the patient's general health condition
  • Absence of patient referrals
  • Lack of consent to continue treatment and follow-up

Treatment and study plan

bevacizumab with oral curcumin

Drug

According to the recommendation of the American Association of Ophthalmologists, intravitreal injection of bevacizumab with a standard dose of 1.25mg/0.05ml in each group will be performed three times consecutively at one-month intervals. In the simultaneous intervention group, patients will take daily curcumin tablets (sinacurcumin product) at a dose of 40 mg twice a day for three months (at the same time as the start of bevacizumab intravitreal injection treatment).

Other names: intervention group

bevacizumab with oral placebo

Drug

Intravitreal injection of bevacizumab with a standard dose of 1.25mg/0.05ml in each group will be performed three times consecutively at one-month intervals. In the control group, patients will be taking daily placebo tablets twice a day for three months (at the same time as the start of bevacizumab intravitreal injection treatment).

Other names: placebo

Primary outcomes

  1. central macular thickness (CMT)

    Time frame: 3 months

    Changes in central macular thickness (CMT) in patients with oral Curcumin versus patients in the control group

  2. central macular volume (CMV)

    Time frame: 3 months

    Changes in central macular volume (CMV) in patients with oral Curcumin versus patients in the control group

Secondary outcomes

  1. best visual acuity (BCVA)

    Time frame: 3 months

    Changes in best visual acuity (BCVA) in patients with oral Curcumin versus patients in the control group

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin in Diabetic Macular Edema

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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