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IRCT20230614058480N1 IRCT 2023-09-19 Zahedan University of Medical Sciences Synergistic effect of Combination of curcumin and piperine supplementation as an adjuvant treatment to the usual treatment method using Bevacizumab in patients with neovascular age-related macular degeneration Comparing the synergistic effect of Combination of curcumin and piperine supplementation as an adjuvant treatment to the usual treatment method using Bevacizumab in patients with neovascular age-related macular degeneration 2023-08-23 anticipated 30 Complete https://irct.ir/trial/70675 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Other, Purpose: Treatment, Randomization description: In this method, we use a table of random numbers and place each client in the intervention or control group. One of the advantages of this type of randomization is that the type of treatment assigned to the two groups is completely unpredictable. 3 Age Related Macular Degeneration. Intervention 1: Intervention group: patients with neovascular AMD and diagnosed with active lesions. Capsules containing curcumin 1000mg with 10mg of piperine will be provided by Biotechnology Research Center, Mashhad University of Medical Sciences. Standard Treatment intervention groups will receive standard treatment of monthly 1.25 mg of intravitreal Bevacizumab Duration of intervention 3 months. Intervention 2: Control group: patients with neovascular AMD and diagnosed with active lesions.placebo Capsules will be provided by Biotechnology Research Center, Mashhad University of Medical Sciences.Standard Treatment intervention groups will receive standard treatment of monthly 1.25 mg of intravitreal Bevacizumab Duration of intervention3 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Personal issues
public Alireza Maleki
Motahhari blvd
Zahedan Iran (Islamic Republic of) 9816743483 +98 54 3329 4395 baaardiyax@gmail.com Zahedan University of Medical Sciences scientific Alireza Maleki
Alzahra ophthalmology hospital, Motahhari Blvd.
Zahedan Iran (Islamic Republic of) 9816743463 +98 54 3337 2151 baaardiyax@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Signed written informed consent Age 45 - 80 years, male or female Neovascular AMD is diagnosed with active lesions 45 years 80 years Both Any history of allergy or sensitivity to turmeric, pepper, curcumin or piperine Any history of allergy or sensitivity to antiVGEFs With vitreous hemorrhage in the studied eyes With geographic atrophy, epiretinal membrane or hard subfoveal exudates involving the foveal in the studied eyes With opacification of the refractive medium (such as apparent cataract) or pupillary constriction that significantly interferes with vision testing or evaluation of the anterior segment and fundus in the study eyes. With rhegmatogenous retinal detachment, macular hole, or choroidal neovascularization (CNV) of any cause other than AMD (eg, fundus angioid streaks, ocular histoplasmosis, pathologic myopia, trauma) in study eyes. With apparent afferent pupillary defect (RAPD) in the studied eyes With polypoidal choroidal vasculopathy (PCV) or retinal angiomatous proliferation (PAP) in the studied eyes With intraocular pressure above 25 mmHg despite treatment With active inflammation in each eye, such as conjunctivitis, keratitis, scleritis, blepharitis, endophthalmitis, and uveitis. The study eye received topical or retinal photocoagulation more than twice or within 3 months before screening. The study eye received the following intraocular surgery or laser therapy in the macula (eg, macular displacement surgery, glaucoma filter surgery, transpupillary thermotherapy, macular photocoagulation, vitreous incision surgery, optic nerve dissection, optic nerve sheath membrane dissection). However, patients who received vertporfin photodynamic therapy, cataract surgery, or YAG posterior capsular dissection more than 3 months prior to screening will not be excluded. Any eye received antiangiogenic drugs in the 2 months before screening or patients who received systemic antiangiogenic drugs in the 3 months before screening (eg, pegaptanib, aflibercept, ranibizumab, bevacizumab, or canbercept). Any eye had received an intraocular injection of a corticosteroid (eg, triamcinolone acetonide) within 3 months prior to screening, or had received an ophthalmic injection of a corticosteroid within 1 month prior to screening for systemic disease, treatment, or other conditions. With a history of sensitivity to sodium fluorescein and indocyanine green PLT≤100×109/L, BUN or Cr>1.5×ULN (upper limit of normal), TT (thrombin time) or PT (prothrombin time) >1.0×ULN (upper limit of normal), take antiplatelet. Medications or anticoagulants 1 month before screening With surgery one month before screening, or with a current unhealed wound, ulcer, or fracture Diabetic patients without glucose control or with diabetic retinopathy With a history of myocardial infarction in the 6 months before screening With intravascular coagulation activity and significant bleeding tendency before screening Systemic autoimmune disease Any uncontrolled disease (such as severe systemic mental, neurological, cardiovascular, respiratory, and malignancies) Pregnant and lactating women or patients who cannot take contraceptive measures Poor compliance Patients who participated in or were currently participating in other clinical trials within 30 days prior to screening. Patients deemed unsuitable for enrollment by the investigator H35.3 Degeneration of macula and posterior pole Treatment - Drugs Treatment - Drugs Intervention group: patients with neovascular AMD and diagnosed with active lesions. Capsules containing curcumin 1000mg with 10mg of piperine will be provided by Biotechnology Research Center, Mashhad University of Medical Sciences. Standard Treatment intervention groups will receive standard treatment of monthly 1.25 mg of intravitreal Bevacizumab Duration of intervention 3 months Control group: patients with neovascular AMD and diagnosed with active lesions.placebo Capsules will be provided by Biotechnology Research Center, Mashhad University of Medical Sciences.Standard Treatment intervention groups will receive standard treatment of monthly 1.25 mg of intravitreal Bevacizumab Duration of intervention3 months Central Sub-Field Retinal Thickness (CSFT). Timepoint: 0,1 month, 2 and 3 months after intervention. Method of measurement: Objective measurement of macular thickness (from OCT findings). Zahedan University of Medical Sciences Approved 2023-07-08 Ethics commitee of Zahedan University of Medical Sciences Mottahari blvd. Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)