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Tests treatment safety and results for Diabetic Macular Edema
Official title Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin
ClinicalTrials.gov ID: NCT06595355
What this study is testing
What is bevacizumab with oral curcumin?
bevacizumab with oral curcumin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for diabetic macular edema.
Also referred to as intervention group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- Patients with center-involving macular edema with macular center thickness more than 300 microns in OCT 2-Patients who did not receive intravitreal...
- 3- The amount of BCVA should not be \<20/400. 4-Consent to participate in the study
You likely can't join if
- Other retinal diseases except for DME and macular edema due to other causes including uveitis, epiretinal membrane, central retinal vein occlusion...
- 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
See the full eligibility 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...
- 3- The amount of BCVA should not be \<20/400. 4-Consent to participate in the study
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Isfahan, Isfahan University of Medical Sciences, Iran
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Isfahan, Isfahan University of Medical Sciences, Iran. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.