N-acetylcysteine for diabetic retinopathy in adults with type 2 diabetes
Official title: Effect of N-Acetyl Cysteine on Oxidative Stress and Clinical Outcome of Patients With Diabetic Retinopathy
Run by Ain Shams University · NCT07634991 · Data updated 2026-11-12
This study tests whether taking N-acetylcysteine for three months can help people with type 2 diabetes who have mild to moderate diabetic retinopathy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 76 (estimated) |
| Sponsor | Ain Shams University Academic / other |
| Locations | 2 sites (Cairo and 1 other locations) |
| Status | Recruiting |
| Started | January 10, 2026 |
| Main results expected | December 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT07634991 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18-70 with type 2 diabetes and mild to moderate diabetic retinopathy, HbA1c < 10%, fasting glucose < 240 mg/dL, BMI < 40 kg/m2, and willingness to adhere to the regimen.
✕Probably not a fit
Participants with other eye diseases, prior retina procedures, antioxidant use, recent anti-VEGF therapy, severe liver/renal disease, pregnancy, or current participation in another trial may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-dummy trial compares N-acetylcysteine 1200 mg daily to placebo for 3 months, in addition to standard diabetes care. Participants undergo baseline and follow-up assessments including visual function, blood pressure, retinopathy staging, and blood tests for glucose, lipids, and oxidative stress markers like glutathione peroxidase and VEGF. Weekly phone check-ins and monthly in-person visits monitor adherence and safety. The study aims to determine if NAC can modulate pathways linked to retinal angiogenesis and permeability in type 2 diabetes. Lead sponsorship is Ain Shams University with collaboration from the National Institute of Diabetes and Endocrinology in Egypt, recruiting adults aged 18-70 with mild to moderate diabetic retinopathy.
Why it matters
Potential benefit: If successful, NAC could slow progression of retinopathy or improve retinal health in patients with type 2 diabetes.
How similar studies have gone: Previous literature supports NAC safety and potential vascular and oxidative benefits; this is among the first to test NAC for diabetic retinopathy in type 2 diabetes.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
National Institute of Diabetes and Endocrinology.
Cairo, Egypt Recruiting -
National Institute of Diabetes and Endocrinology.
Cairo, Egypt Recruiting
Study contacts
- Study coordinator: Nelly tarek Hegazy
- Email: nelly.tariq@pharma.asu.edu.eg
- Phone: 01010008548
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Automated AI system to detect diabetic retinopathy in adults with diabetes
A AI-based software device is being tested to automatically detect diabetic retinopathy from retinal images in adults with diabetes.
-
Early imaging changes with faricimab versus biosimilar ranibizumab for diabetic retinal disease
This trial will see if faricimab or a biosimilar ranibizumab causes different early OCT and OCTA imaging changes in adults with diabetic retinopathy or diabetic macular edema who need anti-VEGF injections.
-
Finding protein biomarkers for AMD, diabetic retinopathy, and retinal detachment
This project will test whether proteins found in blood and eye fluids can help diagnose or predict outcomes for adults with AMD, diabetic retinopathy, or retinal detachment.
-
Diabetic retinopathy prevalence and risk factors at a Da Nang hospital
We will find how common different stages of diabetic retinopathy are and which clinical or lab factors are linked to it among adults with diabetes treated at a Da Nang hospital.
-
AI-assisted retinal photo screening for adults with diabetes
This will test whether adding the VUNO Med®-Fundus AI tool to routine retinal photo screening helps adults with type 2 diabetes get more accurate referrals for diabetic retinopathy.
-
New-generation diabetes medicines and the onset of diabetic retinopathy
This study will test whether newer diabetes medicines (SGLT2 and DPP‑4 inhibitors) can delay diabetic retinopathy in people with type 2 diabetes who've had the disease for more than five years and have been on diabetes medications for 2–3 years.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.