Diabetic macular edema. Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema
Conditions
Interventions
Intervention 1: Intervention group: Participants will receive one capsule of curcumin 500 mg every 12 hours and one capsule of piperine 5 mg every 12 hours. The capsules will be prepared manually in a
Sponsors
Zahedan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of diabetic macular edema Having type 2 diabetes mellitus with a disease duration of at least 6 months Age between 30 and 75 years Visual acuity between 20/40 and 20/200 on the Snellen chart willingness to participate in the study
Exclusion criteria
Exclusion criteria: Receipt of new treatments (such as anti-VEGF injection or laser therapy) within the past 3 months History of hypersensitivity or allergic reaction to curcumin, piperine, or related compounds Presence of other ocular diseases (e.g., advanced glaucoma, severe non-proliferative retinopathy) History of active autoimmune disease Presence of advanced proliferative diabetic retinopathy Presence of geographic atrophy, epiretinal membrane, or hard exudates involving the fovea Media opacity (e.g., significant cataract, vitreous hemorrhage) or pupillary contraction significantly interfering with visual testing, anterior segment examination, or fundus evaluation in the study eye Presence of rhegmatogenous retinal detachment, macular hole, or choroidal neovascularization (CNV) due to causes other than diabetes (such as angioid streaks, ocular histoplasmosis, pathologic myopia, trauma) in the study eye Positive Marcus Gunn pupil History of intraocular surgery within the past 6 months Uncontrolled glaucoma with intraocular pressure >25 mmHg despite maximal medical therapy Active ocular inflammation such as keratitis, conjunctivitis, or uveitis Intraocular corticosteroid injection (e.g., triamcinolone acetonide) within 3 months prior to screening, or periocular corticosteroid injection within 1 month prior to screening History of hypersensitivity to sodium fluorescein or indocyanine green Any retinal disorder other than diabetic retinopathy Surgery within 1 month prior to screening Unhealed wounds or fractures History of myocardial infarction within 6 months prior to screening Any malabsorption-related disorder such as celiac disease Any uncontrolled condition (e.g., severe systemic psychiatric, neurological, cardiovascular, respiratory diseases, or malignancies) Pregnant or breastfeeding women, or patients unable to adhere to contraceptive measures Participation in another clinical trial within 30 days prior to screening, or concurrent enrollment in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central macular thickness on OCT. Timepoint: At the beginning of the study and after 12 weeks of taking the drugs. Method of measurement: Using OCT. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSeyed Alireza Emami Meybodi
Zahedan University of Medical Sciences
Outcome results
None listed