A Phase 2/3 interventional study of bevacizumab with oral curcumin and bevacizumab with oral placebo in Diabetic Macular Edema, Macular Edema and Retinal Neovascularization, sponsored by Isfahan University of Medical Sciences. Recruiting at 1 site in Iran, Islamic Republic of. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Isfahan University of Medical Sciences · Phase 2/3, Interventional, and Treatment
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.
756 studies on the registry are indexed under Macular Edema; 65 are open to participants now.
This study's planned enrollment of 52 is close to the median of 56 across 584 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Isfahan University of Medical Sciences is the lead sponsor of 150 studies on the registry; 8 are open to participants now.
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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 in the last 6 months.
3- The amount of BCVA should not be \<20/400. 4-Consent to participate in the study
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Intravitreal injection of bevacizumab with oral placebo
Drug: bevacizumab with oral placebo
Drug pages: Bevacizumab · 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).
Also known as: intervention group
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
central macular thickness (CMT)
Changes in central macular thickness (CMT) in patients with oral Curcumin versus patients in the control group
Time frame: 3 months
central macular volume (CMV)
Changes in central macular volume (CMV) in patients with oral Curcumin versus patients in the control group
Time frame: 3 months
best visual acuity (BCVA)
Changes in best visual acuity (BCVA) in patients with oral Curcumin versus patients in the control group
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2021 (actual). Primary completion is estimated for Sep 2025, 47 months after the start.
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Studies of the drugs tested here: Bevacizumab · Curcumin
Isfahan University of Medical Sciences →