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NCT07634991RecruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 9 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
76 (estimated)
First submitted
24 May 2026
Start date
10 Jan 2026
Primary completion date
30 Dec 2026
Lead sponsor
Ain Shams University
NCT number
NCT07634991

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 76
  • From 10 Jan 2026 to the primary completion date, 30 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
National Institute of Diabetes and Endocrinology.
Coordinator of this site? Confirm its status
CairoEgyptRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.