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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAin Shams University

About this trial

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

Qualifiers

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

Disqualifiers

• Patients with any other ophthalmologic conditions than diabetic retinopathy

Patients with previous surgical or laser treatment

Pregnant or breastfeeding patients

Patients using antioxidants.

Trial design

Treatments tested in this trial

  • N Acetyl cysteine, 1200mg (high dose)

Treatment groups

76 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Ain Shams University

Lead sponsor

National Institute of Diabetes and Endocrinology, Egypt

Collaborator