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

Sponsor
Isfahan University of Medical Sciences
Study ID
NCT06595355
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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).
  • 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).

Study Details

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.

Key Dates

First listed
Sep 19, 2024
Start date
Oct 10, 2021
Status verified
Sep 2024
Primary completion
Sep 22, 2025
Completion
Sep 22, 2025

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Case: Intravitreal injection of bevacizumab with oral curcumin
    Intravitreal injection of bevacizumab with oral curcumin Inclusion criteria: Patients with center-involving macular edema with macular center thickness of more than 300 microns in OCT 2-Patients who did not receive intravitreal bevacizumab in the last 3 months and intravitreal corticosteroids in the previous 6 months. 3- The amount of BCVA should not be \<20/400. 4-Consent to participate in the study
  • Placebo Comparator: Control: Intravitreal injection of bevacizumab with oral placebo
    Intravitreal injection of bevacizumab with oral placebo

Primary Outcome Measure

central macular thickness (CMT) [ Time Frame: 3 months ]

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