NCT07634991 To Evaluate the Efficacy and Safety of N-acetyl Cysteine Administration in Patients With Diabetic Retinopathy
| NCT ID | NCT07634991 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ain Shams University |
| Condition | Diabetic Retinopathy (DR) |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2026-01-10 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 76 participants in total. It began in 2026-01-10 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07634991 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Diabetic Retinopathy (DR). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07634991 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07634991 currently recruiting?
Yes, NCT07634991 is actively recruiting participants. Contact the research team at nelly.tariq@pharma.asu.edu.eg for enrollment information.
Where is the NCT07634991 trial being conducted?
This trial is being conducted at Cairo, Egypt, Cairo, Egypt.
Who is sponsoring the NCT07634991 clinical trial?
NCT07634991 is sponsored by Ain Shams University. The trial plans to enroll 76 participants.