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

Phase 2

Recruiting

• Conditions: Diabetic Macular Edema; Macular Edema; Retinal Neovascularization

• Registration Number: NCT06595355
• Lead Sponsor: Isfahan University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-10
• Status Verified: 2024-09
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13
• Primary Completion: 2025-09-22
• Study Completion: 2025-09-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
central macular thickness (CMT)	3 months	Changes in central macular thickness (CMT) in patients with oral Curcumin versus patients in the control group
central macular volume (CMV)	3 months	Changes in central macular volume (CMV) in patients with oral Curcumin versus patients in the control group

Secondary Outcome Measures

Name	Time	Method
best visual acuity (BCVA)	3 months	Changes in best visual acuity (BCVA) in patients with oral Curcumin versus patients in the control group