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RECRUITING
NCT06595355
PHASE2/PHASE3

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

Sponsor: Isfahan University of Medical Sciences

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2021-10-10

Completion Date

2025-09-22

Last Updated

2024-09-19

Healthy Volunteers

No

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).

Locations (1)

Mohsen Pourazizi

Isfahan, Isfahan University of Medical Sciences, Iran