RecruitingPhase 4

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

Egypt76 participantsStarted 2026-01-10

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase 4 trial, does that mean N-acetyl cysteine is already considered safe for general use, and what's different about how it's being studied here specifically for diabetic retinopathy?
2The trial is measuring changes in glutathione peroxidase levels — can you explain what that enzyme does in the eye and why improving it might matter for my retinopathy, in terms I can understand?
3How does taking N-acetyl cysteine in this trial compare to the standard treatments I might already be a candidate for, and would joining this study mean delaying or replacing any of those options?
4What would my involvement actually look like day-to-day — how often would I need to come in for visits or testing, and is that realistic given my current care schedule for diabetes and my eyes?
5Given that this trial is still recruiting, are there things about my specific stage of diabetic retinopathy or my other health conditions that might affect whether this would even be a good fit worth discussing further?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in glutathione peroxidase levels

Timeframe: will be measured at time 0 and after 3 months of taking n acetyl cysteine

Trial details

NCT IDNCT07634991

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

Contact for this trial

Nelly tarek Hegazy

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

View on ClinicalTrials.gov More Diabetic Retinopathy (DR) trials