IRCT20230614058480N1招募中3 期
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
Zahedan University of Medical Sciences0 个研究点目标入组 30 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 45 years 至 80 years（—）
- 性别
- All
入选标准
- •Signed written informed consent
- •Age 45 - 80 years, male or female
- •Neovascular AMD is diagnosed with active lesions
排除标准
- •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
研究者
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