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

Effect of N-Acetyl Cysteine on Oxidative Stress and Clinical Outcome of Patients With Diabetic Retinopathy

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetic Retinopathy (DR)
• Intervention / Treatment: Drug: N Acetyl cysteine, 1200mg (high dose)

Detailed Description

Eligible patients will be randomly assigned into one of two groups. In the first group : patients will receive N-acetyl cysteine 1200 mg once daily for three months.

In addition to the standard of care antidiabetic management. In the second group: patients will take matched placebo for three months. In addition to the standard of care antidiabetic management.

1. Demographic data collection and history taking:

   1. Age
   2. Gender
   3. BMI
   4. Smoking status
   5. Diabetes duration
   6. Family history
   7. Medical history: Hypertension, Dyslipidemia, etc.
   8. Medications history especially those related to the occurrence of retinopathy

2. Clinical assessment, scoring & investigations:

   1. Systolic and diastolic blood pressures.
   2. Stage of retinopathy
   3. Ophthalmologic examination:
   4. Clinical examination to assess:Visual acuity and Field of vision

3. Laboratory assessment:

   1. Blood glucose measurement
   2. HbA1c level (%)
   3. HDL cholesterol (mmol/L)
   4. Non-HDL cholesterol (mmol/L)
   5. LDL cholesterol (mmol/L)
   6. Triglyceride (mmol/L)
   7. Glutathione peroxidase
   8. VEGF All patients will be followed up regularly for 3 months during the study period. They will be followed up weekly through telephone calls and will return every 4 weeks for clinical evaluation as well as verification of adherence to the study regimen. Any addition or deletion of a medication used by the study patients will be reported and dealt with if necessary.

At the end of the study the same tests will be repeated to compare the patients before and after taking N-acetyl cysteine.

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nelly tarek Hegazy; Phone Number: 01010008548; Email: nelly.tariq@pharma.asu.edu.eg
• Study Contact Backup: Name: Lamiaa Elwakeel, Professor

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • National Institute of Diabetes and Endocrinology.
    • Contact: National Institute of Diabetes and Endocrinology. National Institute of Diabetes and Endocrinology.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: NPDR patients will receive placebo for three months.; The patients will receive placebo for three months. In addition to the standard of care antidiabetic management.
Experimental: NPDR patients will receive N-acetyl cysteine 1200 mg once daily for three months.	Drug: 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(

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ain Shams University
• Collaborators: National Institute of Diabetes and Endocrinology, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: May 24, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Eye Diseases; Diabetic Angiopathies; Diabetes Complications; Retinal Diseases; Diabetic Retinopathy; Amino Acids, Peptides, and Proteins; Sulfur Compounds; Organic Chemicals; Amino Acids; Cysteine; Amino Acids, Sulfur; Acetylcysteine
• Other Study ID Numbers: REC#240

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes