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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Islamic Republic of Iran
Mohsen Pourazizi
RECRUITING
Isfahan
Time Frame
Start Date: 2021-10-10
Estimated Completion Date: 2025-09-22
Participants
Target number of participants: 52
Treatments
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
Sponsors
Leads: Isfahan University of Medical Sciences

This content was sourced from clinicaltrials.gov