Oral N-Acetylcysteine on Diabetic Macular Edema
NCT07917338, Phase 2, Recruiting, Khadija Ahmed Mhrose Glal
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Oral N-Acetylcysteine on Diabetic Macular Edema | ClinicalTrials.gov |
| NCT number | NCT07917338 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 50 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Khadija Ahmed Mhrose Glal | ClinicalTrials.gov |
| Conditions | Diabetic Macular Edema (DME) | ClinicalTrials.gov |
| Interventions | NAC | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from Baseline in Central Subfield Thickness (CST) Measured by Spectral-Domain Optical Coherence Tomography (SD-OCT) | 3 months | 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. | ClinicalTrials.gov |
| Secondary | Change from Baseline in Serum Malondialdehyde (MDA) Concentration | 3 months | 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. | ClinicalTrials.gov |
| Secondary | Change from Baseline in Serum Angiopoietin-2 (Ang-2) Concentration | 3 months | 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. | ClinicalTrials.gov |
| Secondary | Change from Baseline in Best-Corrected Visual Acuity (BCVA) Measured Using a Standardized Tumbling E Chart | 3 months | 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. | ClinicalTrials.gov |
| Secondary | Number of Participants Requiring Rescue Therapy for Diabetic Macular Edema During the Study Period | 3 months | 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. | ClinicalTrials.gov |
| Secondary | Number of Participants Experiencing at Least One Adverse Event | 3 months | 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 | ClinicalTrials.gov |
| Secondary | Number of Participants Experiencing at Least One Serious Adverse Event | 3 months | 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. | ClinicalTrials.gov |
| Secondary | Number of Participants Discontinuing Study Medication Due to Adverse Events or Intolerance | 3 months | The number of participants who discontinue the study medication because of adverse events, intolerance, or safety concerns during the intervention period will be recorded. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)