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

NCT07634991 | Recruiting Phase 4 FDA Drug

• 1 other identifier: REC#240
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Diabetic Retinopathy (DR)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

NPDR patients will receive placebo for three months.

NO INTERVENTION

The patients will receive placebo for three months. In addition to the standard of care antidiabetic management.

NPDR patients will receive N-acetyl cysteine 1200 mg once daily for three months.

EXPERIMENTAL

NPDR patients will receive N-acetyl cysteine 1200 mg once daily for three months.

Drug: N Acetyl cysteine, 1200mg (high dose)

Interventions

N Acetyl cysteine, 1200mg (high dose) DRUG

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(

NPDR patients will receive N-acetyl cysteine 1200 mg once daily for three months.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead
• National Institute of Diabetes and Endocrinology, Egypt: collaborator

Study Sites (2)

National Institute of Diabetes and Endocrinology.

Cairo, Egypt

RECRUITING

National Institute of Diabetes and Endocrinology.

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Nelly tarek Hegazy

CONTACT

01010008548; nelly.tariq@pharma.asu.edu.eg

Lamiaa Elwakeel, Professor

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 9, 2026
• Study Start: January 10, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 9, 2026

Record last verified: 2026-05

Locations

EG (2)