Oral N-Acetylcysteine for Diabetic Macular Edema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial evaluates the effect of oral N-acetylcysteine in adults with type 2 diabetes and center-involving diabetic macular edema who are eligible for observation without immediate anti-VEGF treatment. Participants will receive NAC to see if it can reduce retinal swelling and improve vision by addressing oxidative stress and inflammatory pathways linked to diabetic retinal injury. The study focuses on patients aged 18 to 69 with good baseline visual acuity and clear ocular media to allow reliable OCT assessment. Key outcomes likely include changes in macular thickness and visual acuity, alongside safety and tolerability of oral NAC. The trial is conducted at a single center under a lead sponsor from Khadija Ahmed Mhrose Glal and may inform future randomized testing of NAC in DME.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with type 2 diabetes mellitus
* Adults aged \>18 and \<70 years.
* Patients of either sex.
* Patients with center-involving diabetic macular edema (CI-DME) with best-corrected visual acuity of 20/25 or better in the study eye and who are considered eligible for observation without immediate anti-VEGF treatment according to predefined ophthalmological criteria.
* Clear ocular media allowing good quality OCT macula imaging.

Exclusion Criteria:

* Presence of ophthalmic diseases other than diabetic retinopathy that may affect macular thickness or visual function (Age-related macular degeneration, epiretinal membrane, vitreomacular traction, significant cataract affecting visual assessment, retinal vein occlusion, uveitis, glaucoma, etc.)
* Pregnancy or breastfeeding.
* Current use of systemic antioxidant supplements or antioxidant therapy that could interfere with the study outcomes.
* History of ocular surgery or laser.
* Systemic diseases affecting retinal microvasculature other than diabetes (e.g., uncontrolled hypertension, vasculitis).
* Poor image quality (media opacity, interferes with OCT imaging).

Where it's running

• Al-Azhar Hospital, Damietta
  Damietta, Egypt Recruiting

Study contacts

• Study coordinator: Esraa Farag
• Email: Esraa.AhmedF@pharm.psu.edu.eg
• Phone: +201026156317

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.