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Recruiting Phase 4

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

NCT07634991 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 4
Started
2026-01-10
Last updated
2026-06-09

Condition(s) studied

Diabetic Retinopathy (DR)

Investigational drug(s) / intervention(s)

N Acetyl cysteine, 1200mg (high dose) →

N Acetyl cysteine, 1200mg (high dose): N-acetylcysteine (NAC), alternatively referred to as N-acetyl-L-cysteine, is an acetylated version of the amino acid L-cysteine, with the chemical formula C5H9NO3S. Initially employed to thin stubborn bronchial secretions, NAC has found application in treating chronic bronchitis and various pulmonary ailments to address thick mucus. Remarkably, NAC functions as both a direct antioxidant and a precursor to glutathione. It effectively eliminates reactive oxygen species (ROS), such as hydroxyl radicals, hypochlorous acid, and hydrogen peroxide. These ROS have the potential to oxidize lipids, proteins, and DNA, generating carbon-centered radicals along the DNA backbone, ultimately leading to cell death.The thiol group in NAC is responsible for its antioxidant properties. Additionally, NAC can be metabolized into cysteine, a key building block in the synthesis of glutathione. Glutathione plays a crucial role as an antioxidant, protecting cellular components from damage caused by ROS(

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Changes in glutathione peroxidase levels — will be measured at time 0 and after 3 months of taking n acetyl cysteine
    Changes in glutathione peroxidase levels in patients with diabetic retinopathy treated with N-acetyl cysteine.

Trial sites (2)

FacilityCityRegionStatus
National Institute of Diabetes and Endocrinology. Cairo Egypt Recruiting
National Institute of Diabetes and Endocrinology. Cairo Egypt Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07634991 on ClinicalTrials.gov ↗ ← All trials in Egypt