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

NCT07634991 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-06-09

No results posted yet for this 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.

Conditions

  • Diabetic Retinopathy (DR)

Interventions

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(

Sponsors & Collaborators

  • National Institute of Diabetes and Endocrinology, Egypt

    collaborator UNKNOWN

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-10
Primary Completion
2026-12-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07634991 on ClinicalTrials.gov