A Phase 2 interventional study of NAC in Diabetic Macular Edema (DME), sponsored by Khadija Ahmed Mhrose Glal. Recruiting at 1 site in Egypt. Open to participants aged 19 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Khadija Ahmed Mhrose Glal · Phase 2, Interventional, and Treatment
Diabetic retinopathy (DR) is one of the leading causes of preventable visual impairment among working-age adults, with diabetic macular edema (DME) representing one of its most important vision-threatening complications. Diabetic macular edema develops when diabetes-associated retinal vascular dysfunction leads to disruption of the blood-retinal barrier (BRB), allowing fluid and plasma components to accumulate within the retinal tissue and impair macular function. The development and persistence of DME involve a complex interplay between vascular, inflammatory, metabolic, and oxidative mechanisms.
Hyperglycemia is a central driver of the molecular abnormalities underlying diabetic retinal injury. Chronic exposure to elevated glucose activates several interrelated pathways, including the polyol, advanced glycation end-products (AGEs), protein kinase C (PKC), and hexosamine pathways. These metabolic disturbances promote the generation of reactive oxygen species (ROS), inflammatory signaling, endothelial dysfunction, and progressive impairment of the retinal neurovascular unit. Together, these processes contribute to damage to endothelial cells, pericytes, Müller cells, and other retinal components, ultimately compromising the integrity of the BRB.
Oxidative stress is therefore considered an important component of the pathophysiology of DR and DME. Excessive ROS production can directly damage cellular structures and can also amplify inflammatory and angiogenic signaling. This may increase the expression of several mediators implicated in retinal vascular dysfunction. The resulting vascular instability and increased permeability facilitate fluid extravasation into the retinal layers and contribute to the development and progression of DME.
Malondialdehyde (MDA), a product of lipid peroxidation, is widely used as a marker of oxidative damage. Increased MDA concentrations have been reported in patients with diabetic retinopathy and have been associated with the presence or severity of retinal disease, supporting the involvement of oxidative stress in diabetic retinal injury. Assessment of MDA may therefore provide a useful systemic indicator of the oxidative component of the disease process.
Angiopoietin-2 (Ang-2), an important regulator of vascular stability, has also been implicated in diabetic retinal vascular dysfunction. Increased Ang-2 can promote endothelial destabilization and enhance vascular permeability, particularly in the presence of inflammatory and VEGF-related signaling. Thus, oxidative stress and angiogenic dysregulation may represent interconnected components of the vascular injury that ultimately leads to BRB disruption and retinal fluid accumulation.
Current management of DME relies predominantly on ophthalmic interventions, with corticosteroids and laser photocoagulation having roles in selected clinical settings. Although these approaches have substantially improved visual and anatomical outcomes, persistent or recurrent edema occurs in a proportion of patients, reflecting the multifactorial nature of DME and the involvement of various pathways.
N-acetylcysteine (NAC) is a thiol-containing compound and a precursor of L-cysteine and reduced glutathione. In addition to its established mucolytic properties, NAC has antioxidant activity through direct scavenging of reactive oxygen species and, importantly, through restoration of intracellular glutathione availability. Its ability to modulate oxidative stress has led to extensive investigation of NAC in a variety of clinical conditions characterized by oxidative and inflammatory injury.
Experimental evidence suggests that attenuation of oxidative stress with NAC may reduce diabetes-related retinal injury and suppress the expression of vascular and inflammatory mediators, including VEGF and intercellular adhesion molecule-1 (ICAM-1). However, the potential clinical relevance of oral NAC in patients with diabetic retinal disease remains insufficiently characterized.
756 studies on the registry are indexed under Macular Edema; 65 are open to participants now.
This study's planned enrollment of 50 is below the median of 56 across 584 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →This is the only study on the registry with Khadija Ahmed Mhrose Glal as lead sponsor.
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Exclusion Criteria:
Drug: NAC
N-acetylcysteine (NAC) at a total daily dose of 1200 mg, administered as 600 mg twice daily
Change from Baseline in Central Subfield Thickness (CST) Measured by Spectral-Domain Optical Coherence Tomography (SD-OCT)
Central subfield thickness (CST), defined as the retinal thickness within the central 1-mm subfield centered on the fovea, will be measured using spectral-domain optical coherence tomography (SD-OCT; DRI OCT Triton, Topcon, Japan). The change in CST from baseline to the end of the 3-month intervention period will be evaluated.
Time frame: 3 months
Change from Baseline in Serum Malondialdehyde (MDA) Concentration
Serum malondialdehyde (MDA), a biomarker of oxidative stress, will be measured at baseline and at the end of the 3-month intervention period. The change in serum MDA concentration from baseline to 3 months will be assessed.
Time frame: 3 months
Change from Baseline in Serum Angiopoietin-2 (Ang-2) Concentration
Serum angiopoietin-2 (Ang-2), a biomarker of vascular destabilization and angiogenic signaling, will be measured at baseline and at the end of the 3-month intervention period. The change in serum Ang-2 concentration from baseline to 3 months will be assessed.
Time frame: 3 months
Change from Baseline in Best-Corrected Visual Acuity (BCVA) Measured Using a Standardized Tumbling E Chart
Best-corrected visual acuity (BCVA) will be assessed using a standardized Tumbling E chart at a distance of 6 meters with appropriate refractive correction. Visual acuity will be recorded according to the predefined chart scoring system and converted to logarithm of the minimum angle of resolution (logMAR) for statistical analysis. The change in BCVA from baseline to 3 months will be evaluated.
Time frame: 3 months
Number of Participants Requiring Rescue Therapy for Diabetic Macular Edema During the Study Period
The number of participants requiring rescue ophthalmological treatment due to clinically significant visual deterioration or worsening of diabetic macular edema during the 3-month follow-up period will be recorded. Rescue treatments may include anti-VEGF therapy, intravitreal corticosteroids, or laser treatment, according to the treating ophthalmologist's clinical judgment and predefined study criteria.
Time frame: 3 months
Number of Participants Experiencing at Least One Adverse Event
The number of participants experiencing at least one adverse event during the intervention period will be recorded. Adverse events will be monitored through weekly telephone follow-up and mont
Time frame: 3 months
Number of Participants Experiencing at Least One Serious Adverse Event
The number of participants experiencing at least one serious adverse event during the intervention period will be recorded and documented, with appropriate clinical management and assessment of the possible relationship to the study medication.
Time frame: 3 months
Number of Participants Discontinuing Study Medication Due to Adverse Events or Intolerance
The number of participants who discontinue the study medication because of adverse events, intolerance, or safety concerns during the intervention period will be recorded.
Time frame: 3 months
Started Oct 2026 (actual). Primary completion is estimated for Oct 2027, 11 months after the start.
Of 50 phase 2 interventional studies under Macular Edema, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 32. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Acetylcysteine