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 degeneratio

Phase 3

Recruiting

• Conditions: Age Related Macular Degeneration.; Degeneration of macula and posterior pole; H35.3

• Registration Number: IRCT20230614058480N1
• Lead Sponsor: Zahedan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Signed written informed consent
Age 45 - 80 years, male or female
Neovascular AMD is diagnosed with active lesions

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).