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

NCT ID: NCT06595355

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-10
• Study Completion Date: 2025-09-22

Brief 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.

Conditions

Diabetic Macular Edema; Macular Edema; Retinal Neovascularization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

bevacizumab with oral curcumin

Intervention Type: 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).

Control: Intravitreal injection of bevacizumab with oral placebo

Intravitreal injection of bevacizumab with oral placebo

Group Type: PLACEBO_COMPARATOR

bevacizumab with oral placebo

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Other Intervention Names

intervention group; placebo

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

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Isfahan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Mohsen Pourazizi

Dr.Mohsen Pourazizi

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mohsen Pourazizi

Isfahan, Isfahan University of Medical Sciences, Iran

Site Status: RECRUITING

Countries

Iran

Facility Contacts

Mohsen Pourazizi, Doctor

Role: primary

m.pourazizi@yahoo.com

+983134452031

Other Identifiers

IR.ARI.MUI.REC.1402.336

Identifier Type: -

Identifier Source: org_study_id