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

NCT06595355 | Recruiting Phase 2

• 1 other identifier: IR.ARI.MUI.REC.1402.336
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Keywords

macular edema; diabetic macular edema; central macular edema; bevacizumab; Diabetic Retinopathy; Retinal Neovascularization

Outcome Measures

Primary Outcomes (2)

• central macular thickness (CMT)

  Changes in central macular thickness (CMT) in patients with oral Curcumin versus patients in the control group

  3 months

• central macular volume (CMV)

  Changes in central macular volume (CMV) in patients with oral Curcumin versus patients in the control group

  3 months

Secondary Outcomes (1)

• best visual acuity (BCVA)

  3 months

Study Arms (2)

Case: Intravitreal injection of bevacizumab with oral curcumin

EXPERIMENTAL

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

Drug: bevacizumab with oral curcumin

Control: Intravitreal injection of bevacizumab with oral placebo

PLACEBO COMPARATOR

Intravitreal injection of bevacizumab with oral placebo

Drug: bevacizumab with oral placebo

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).

Also known as: intervention group

Case: Intravitreal injection of bevacizumab with oral curcumin

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).

Also known as: placebo

Control: Intravitreal injection of bevacizumab with oral placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The amount of BCVA should not be \<20/400. 4-Consent to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Mohsen Pourazizi

Isfahan, Isfahan University of Medical Sciences, 8174673461, Iran

RECRUITING

MeSH Terms

Conditions

Macular Edema; Retinal Neovascularization; Diabetic Retinopathy

Interventions

Bevacizumab; Curcumin

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Mohsen Pourazizi

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 10, 2021
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)