Diabetic Retinopathy (DR)Phase 4NCT07634991
To Evaluate the Efficacy and Safety of N-acetyl Cysteine Administration in Patients With Diabetic Retinopathy
A Phase 4 study testing N Acetyl cysteine, 1200mg (high dose) in people with Diabetic Retinopathy (DR), run by Ain Shams University at 2 sites in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetic Retinopathy (DR)
- What is being tested?
- N Acetyl cysteine, 1200mg (high dose)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Jan 2026to 30 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lamiaa Elwakeel, Professor contact
Egypt2 sites, 2 recruiting
- Recruiting
National Institute of Diabetes and Endocrinology.
Cairo
National Institute of Diabetes and Endocrinology. National Institute of Diabetes and Endocrinology.
- Recruiting
National Institute of Diabetes and Endocrinology.
Cairo
About this study
Official title: Effect of N-Acetyl Cysteine on Oxidative Stress and Clinical Outcome of Patients With Diabetic Retinopathy
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.
Read the detailed description
Eligible patients will be randomly assigned into one of two groups. In the first group : patients will receive N-acetyl cysteine 1200 mg once daily for three months.
In addition to the standard of care antidiabetic management. In the second group: patients will take matched placebo for three months. In addition to the standard of care antidiabetic management.
- Demographic data collection and history taking:
- Age
- Gender
- BMI
- Smoking status
- Diabetes duration
- Family history
- Medical history: Hypertension, Dyslipidemia, etc.
- Medications history especially those related to the occurrence of retinopathy
- Clinical assessment, scoring \& investigations:
- Systolic and diastolic blood pressures.
- Stage of retinopathy
- Ophthalmologic examination:
- Clinical examination to assess:Visual acuity and Field of vision
- Laboratory assessment:
- Blood glucose measurement
- HbA1c level (%)
- HDL cholesterol (mmol/L)
- Non-HDL cholesterol (mmol/L)
- LDL cholesterol (mmol/L)
- Triglyceride (mmol/L)
- Glutathione peroxidase
- VEGF All patients will be followed up regularly for 3 months during the study period. They will be followed up weekly through telephone calls and will return every 4 weeks for clinical evaluation as well as verification of adherence to the study regimen. Any addition or deletion of a medication used by the study patients will be reported and dealt with if necessary.
At the end of the study the same tests will be repeated to compare the patients before and after taking N-acetyl cysteine.
- Conditions
- Diabetic Retinopathy (DR)
- Being tested
- N Acetyl cysteine, 1200mg (high dose)
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N Acetyl cysteine, 1200mg (high dose)Drug
N-acetylcysteine (NAC), alternatively referred to as N-acetyl-L-cysteine, is an acetylated version of the amino acid L-cysteine, with the chemical formula C5H9NO3S. Initially employed to thin stubborn bronchial secretions, NAC has found application in treating chronic bronchitis and various pulmonary ailments to address thick mucus. Remarkably, NAC functions as both a direct antioxidant and a precursor to glutathione. It effectively eliminates reactive oxygen species (ROS), such as hydroxyl radicals, hypochlorous acid, and hydrogen peroxide. These ROS have the potential to oxidize lipids, proteins, and DNA, generating carbon-centered radicals along the DNA backbone, ultimately leading to cell death.The thiol group in NAC is responsible for its antioxidant properties. Additionally, NAC can be metabolized into cysteine, a key building block in the synthesis of glutathione. Glutathione plays a crucial role as an antioxidant, protecting cellular components from damage caused by ROS(
| Study group | Role | What they receive |
|---|---|---|
| NPDR patients will receive placebo for three months. | No intervention | The patients will receive placebo for three months. In addition to the standard of care antidiabetic management. |
| NPDR patients will receive N-acetyl cysteine 1200 mg once daily for three months. | Experimental | NPDR patients will receive N-acetyl cysteine 1200 mg once daily for three months. Receives: Drug: N Acetyl cysteine, 1200mg (high dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glutathione peroxidase levels
Changes in glutathione peroxidase levels in patients with diabetic retinopathy treated with N-acetyl cysteine.
Measured: will be measured at time 0 and after 3 months of taking n acetyl cysteine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start10 Jan 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Retinopathy (DR)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Endocrinology, Egypt
- Responsible party
- Principal investigator, Nelly Hegazy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634991
- Sponsor's protocol ID
- REC#240
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of N-Acetyl Cysteine on Oxidative Stress and Clinical Outcome of Patients With Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT07634991
- Acronym / sponsor ID
- REC#240
- Conditions
- Diabetic Retinopathy (DR)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Endocrinology, Egypt
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible patients will be randomly assigned into one of two groups. In the first group : patients will receive N-acetyl cysteine 1200 mg once daily for three months.
In addition to the standard of care antidiabetic management. In the second group: patients will take matched placebo for three months. In addition to the standard of care antidiabetic management.
- Demographic data collection and history taking:
- Age
- Gender
- BMI
- Smoking status
- Diabetes duration
- Family history
- Medical history: Hypertension, Dyslipidemia, etc.
- Medications history especially those related to the occurrence of retinopathy
- Clinical assessment, scoring \& investigations:
- Systolic and diastolic blood pressures.
- Stage of retinopathy
- Ophthalmologic examination:
- Clinical examination to assess:Visual acuity and Field of vision
- Laboratory assessment:
- Blood glucose measurement
- HbA1c level (%)
- HDL cholesterol (mmol/L)
- Non-HDL cholesterol (mmol/L)
- LDL cholesterol (mmol/L)
- Triglyceride (mmol/L)
- Glutathione peroxidase
- VEGF All patients will be followed up regularly for 3 months during the study period. They will be followed up weekly through telephone calls and will return every 4 weeks for clinical evaluation as well as verification of adherence to the study regimen. Any addition or deletion of a medication used by the study patients will be reported and dealt with if necessary.
At the end of the study the same tests will be repeated to compare the patients before and after taking N-acetyl cysteine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NPDR patients will receive placebo for three months. | No intervention | –The patients will receive placebo for three months. In addition to the standard of care antidiabetic management. |
| NPDR patients will receive N-acetyl cysteine 1200 mg once daily for three months. | Experimental | Drug: N Acetyl cysteine, 1200mg (high dose)NPDR patients will receive N-acetyl cysteine 1200 mg once daily for three months. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with type 2 diabetes mellitus
Key exclusion criteria (8 listed)
- • Patients with any other ophthalmologic conditions than diabetic retinopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N Acetyl cysteine, 1200mg (high dose)N-acetylcysteine (NAC), alternatively referred to as N-acetyl-L-cysteine, is an acetylated version of the amino acid L-cysteine, with the chemical formula C5H9NO3S. Initially employed to thin stubborn bronchial secretions, NAC has found application in treating chronic bronchitis and various pulmonary ailments to address thick mucus. Remarkably, NAC functions as both a direct antioxidant and a precursor to glutathione. It effectively eliminates reactive oxygen species (ROS), such as hydroxyl radicals, hypochlorous acid, and hydrogen peroxide. These ROS have the potential to oxidize lipids, proteins, and DNA, generating carbon-centered radicals along the DNA backbone, ultimately leading to cell death.The thiol group in NAC is responsible for its antioxidant properties. Additionally, NAC can be metabolized into cysteine, a key building block in the synthesis of glutathione. Glutathione plays a crucial role as an antioxidant, protecting cellular components from damage caused by ROS( | Drug | NPDR patients will receive N-acetyl cysteine 1200 mg once daily for three months. |
Primary outcome
Changes in glutathione peroxidase levels
Time frame: will be measured at time 0 and after 3 months of taking n acetyl cysteine
Changes in glutathione peroxidase levels in patients with diabetic retinopathy treated with N-acetyl cysteine.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lamiaa Elwakeel, Professor contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing N Acetyl cysteine, 1200mg (high dose) in people with Diabetic Retinopathy (DR), run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nelly tarek Hegazy (01010008548, nelly.tariq@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in glutathione peroxidase levels (time frame: will be measured at time 0 and after 3 months of taking n acetyl cysteine). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.