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To Evaluate the Efficacy and Safety of N-acetyl Cysteine Administration in Patients With Diabetic Retinopathy

RecruitingPhase 4Ages 18 Years - 70 YearsAllAin Shams University
NCT07634991 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

N-acetylcysteine (NAC) emerges as a crucial factor in mitigating oxidative stress and inhibiting vascular endothelial activation in diabetic patients, through its effect on VEGF expression as VEGF is involved in the development of diabetic microvascular complications through the promotion of retinal angiogenesis and increased vascular permeability. It was reported in the literature that NAC administration was safe in several studies. It was shown that the dose of 1200 mg is safe and effective. To the best of our knowledge, the present study is the first to be designed to evaluate the effect of N-acetyl cysteine on diabetic retinopathy in type 2 diabetic patients.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with type 2 diabetes mellitus * Patients with mild to moderate degrees of diabetic retinopathy * Patients over the age of 18 and under the age of 70 years * Patients who voluntarily give their informed consent * HbA1C (glycosylated hemoglobin) less than 10% * FBG less than 240 mg/dl * Body mass index (BMI) less than 40 kg/m2 Exclusion Criteria: * • Patients with any other ophthalmologic conditions than diabetic retinopathy * Patients with previous surgical or laser treatment * Pregnant or breastfeeding patients * Patients using antioxidants. * Systemic anti-VEGF or pro-VEGF treatment within 4 months before randomization * Patients who are currently participating in other clinical trials * Severe liver or renal disease, (AST or ALT \>3 times ULN or Total bilirubin \>3 times ULN), (CrCl\< 60 ml/min) * Current history of drug or alcohol abuse Malignancies
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What it tests

  • N Acetyl cysteine, 1200mg (high dose)
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Where

2 sites
National Institute of Diabetes and Endocrinology.
Cairo, Egypt
National Institute of Diabetes and Endocrinology.
Cairo, Egypt
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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