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Recruiting NCT06595355

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

Phase II / Phase III Interventional Diabetic Macular Edema Macular Edema Retinal Neovascularization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: bevacizumab with oral curcumin, bevacizumab with oral placebo.
Who it may be relevant to
Registry conditions: Diabetic Macular Edema, Macular Edema, Retinal Neovascularization. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Iran
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

Interventions

  • Drug bevacizumab with oral curcumin
    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).
  • Drug bevacizumab with oral placebo
    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).

Primary outcome measures

  • central macular thickness (CMT) [Time frame: 3 months]
  • central macular volume (CMV) [Time frame: 3 months]
Secondary outcome measures (1)
  • best visual acuity (BCVA) [Time frame: 3 months]

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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Iran · 1 center
  • Mohsen Pourazizi — Isfahan

Identifiers

NCT: NCT06595355 · IR.ARI.MUI.REC.1402.336

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗