Diabetic RetinopathyPhase 2NCT04071977
Combined Antioxidant Therapy on Oxidative Stress in Aqueous and Vitreous Humor of Diabetic Retinopathy Patients
A Phase 2 study testing Combined antioxidant therapy in people with Diabetic Retinopathy and Oxidative Stress, run by University of Guadalajara at 1 site in Mexico.
Trial summary
The present study aims to support previous research on the effects of antioxidant therapy on the outcome of diabetic retinopathy and local oxidative stress values. The researchers intend to evaluate 56 patients with proliferative diabetic retinopathy undergoing the vitrectomy procedure, who will be assigned to a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Oxidative Stress, Diabetes
- What is being tested?
- Combined antioxidant therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- 25 Mar 2020to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 with proliferative diabetic retinopathy
- Blood pressure under 160/100 mmHg
- HbA1c equal or lower than 9%
- LDL under 190mg/dl, triglycerides under 500mg/dl)
- Signed informed consent
- Patients scheduled for vitrectomy surgery, under the following indications:
Show all 9Show fewer
- Severe vitreous hemorrhage lasting 1-3 months or longer, which does not go away spontaneously
- Rhegmatogenous or tensile retina detachment
- Epiretinal membrane that involves macula and that includes vitreomacular traction
Who cannot join
- Vitreous hemorrhage for any cause other than Proliferative Diabetic Retinopathy complication
- Patients with vitrectomy surgery in the last 6 months
- Patients with laser surgery in the last 6 months
- Intravitreal application of antiangiogenic agents in the last 2 months
- Patients with other ocular pathologies such as age-related macular degeneration, glaucoma, endophthalmitis, conjunctivitis of any etiology, severe lacrimal film dysfunction syndrome, etc.
- Patients with concomitant systemic diseases such as: rheumatoid arthritis, sjogren's syndrome, upper respiratory tract infections, gastrointestinal infections, sepsis, any infectious process
Show all 12Show fewer
- Patients with severe cardiovascular disease (myocardial infarction, stroke, severe peripheral vascular disease)
- Oral antioxidant intake that exceeds the daily recommendations in the last 6 months.
- Consumption of pharmacological agents such as: immunomodulators, biological, anti-inflammatory, in the last 3 months
- Smokers
- Patients with neurodegenerative or carcinogen processes
- Patients who are currently participating in other clinical trials
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Institute of Experimental and Clinical Therapeutics,
Guadalajara, Jalisco, 44340
About this study
Official title: Effect of Combined Antioxidant Therapy on the Levels of Oxidative Stress Markers in Aqueous and Vitreous Humor of Patients With Proliferative Diabetic Retinopathy
The present study aims to support previous research on the effects of antioxidant therapy on the outcome of diabetic retinopathy and local oxidative stress values. The researchers intend to evaluate 56 patients with proliferative diabetic retinopathy undergoing the vitrectomy procedure, who will be assigned to a placebo group or combination antioxidant therapy. Each group will receive the intervention for 2 months. This intervention consists of taking one tablet (placebo or antioxidant therapy) orally, once a day.
At the beginning of the study, only blood samples will be collected to evaluate the state of oxidative and metabolic stress at a systemic level. After 2 months of intervention, blood samples will be taken again on the day of the intervention, adding the samples of aqueous and vitreous humor obtained during the vitrectomy. The results obtained between both groups and the different analysis matrices will be compared.
Read the detailed description
Diabetic retinopathy is a diabetes microvascular complication due to an insufficient oxygen supply to its endothelial cells in states of constant hyperglycemia. This entity is classified in two main categories: non-proliferative diabetic retinopathy and proliferative diabetic retinopathy, the latter is characterized for the presence of neovascularization as oppose to the first one.
Oxidative stress has been considered as one of the main factors in the development of diabetic retinopathy. It is a result from an imbalance between oxidants production and cellular antioxidant defenses, which provokes DNA damage.
The treatment of diabetic retinopathy simply includes glycemic, lipemic and blood pressure control. Only when the view is compromised is when a vitrectomy is performed, which usually occurs in the more advanced stages such as the proliferative stage. Antioxidant therapy has been used as a coadjuvant for these interventions, complementing the action and efficacy of the treatment established for diabetic retinopathy in the early stages. However, in order to obtain vitreous and aqueous humor, the vitrectomy procedure is required, which is only carried out in the proliferative stage.
Diabetic retinopathy is a specific and chronic complication of diabetes mellitus and is known to have a prevalence of 43.6% internationally and 31.5% in the Mexican population. It represents the main cause of visual blindness and weakness in the economically active population, which also affects the quality of life and the productivity of the people who suffer it.
The researchers intend to evaluate whether antioxidant therapy influences the levels of oxidative stress markers at the ocular level.
- Conditions
- Diabetic Retinopathy, Oxidative Stress, Diabetes
- Being tested
- Combined antioxidant therapy, Placebo
- Keywords
- Vitreous humor, Vitrectomy, Aqueous humor, Antioxidant therapy, Oxidative markers
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined antioxidant therapyDrug
Also called Drusen Laz
It consists of a tablet with lutein (10 mg), astaxanthin (4 mg), Zeaxanthin (1 mg), vitamin C (L-ascorbic acid 180 mg), vitamin E (DL-alpha tocopherol 30 mg), zinc (zinc oxide 20 mg), copper (copper sulfate 1 mg), taken once a day for 12 months
PlaceboOther
Also called Magnesia
It consists in a capsule with 100 mg of magnesium oxide
| Study group | Role | What they receive |
|---|---|---|
| Combined Antioxidant Therapy group | Active comparator | This arm will be administered with the combined antioxidant therapy, and will consist of 28 patients with proliferative diabetic retinopathy (PDR) who will undergo vitrectomy. Receives: Drug: Combined antioxidant therapy |
| Placebo group | Placebo comparator | This arm will be administered with placebo, and will consist of 28 patients with proliferative diabetic retinopathy (PDR) who will undergo vitrectomy. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare levels of markers of oxidative stress in aqueous humor and vitreous humor
The investigators will measure oxidative stress markers in aqueous and vitreous humor taken during vitrectomy procedure and compare such results between both intervention groups.
Measured: 1 measure will be made after 2 months of intervention
Changes in concentration of plasma 8-isoprostanes after intervention.
The investigators will consider changes presented in plasma concentrations of 8-isoprostanes from baseline to the end of the intervention. The investigators expect to find a decrease in 8-isoprostanes concentrations in the supplemented group.
Measured: 2 measures will be made, 1 at baseline, and one after completion of 2 months of intervention
Changes in concentration of total antioxidant capacity (TAC) after intervention from baseline.
The investigators will consider changes presented in plasma concentrations of total antioxidant capacity (TAC) from baseline to the end of the intervention. The investigators expect to find TAC augmentation in the supplemented group.
Measured: 2 measures will be made, 1 at baseline, and one after completion of 2 months of intervention
Secondary outcomes (2)
Correlate the levels of 8-isoprostanes in systemic samples, aqueous humor and vitreous humor with the glycosylated hemoglobin value of patients with proliferative diabetic retinopathy.
The investigators will consider levels of 8-isoprostanes in serum, aqueous humor and vitreous humor after intervention and baseline glycated hemoglobin
Measured: 1 measure of glycated hemoglobin will be taken at baseline
Correlate the levels of total antioxidant capacity (TAC) in systemic samples, aqueous humor and vitreous humor with the glycosylated hemoglobin value of patients with proliferative diabetic retinopathy.
The investigators will consider levels of total antioxidant capacity in serum, aqueous humor and vitreous humor after intervention and baseline glycated hemoglobin
Measured: 1 measure of glycated hemoglobin will be taken at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start25 Mar 2020
- Primary completion31 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical trial phase IIa
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Civil de Guadalajara
- Responsible party
- Principal investigator, Adolfo Daniel Rodriguez-Carrizalez, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04071977
- Sponsor's protocol ID
- RD-20180831
- Status last verified
- Mar 2022
- First submitted
- 26 Aug 2019
- Last updated
- 1 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodriguez-Carrizalez AD, Castellanos-Gonzalez JA, Martinez-Romero EC, Miller-Arrevillaga G, Villa-Hernandez D, Hernandez-Godinez PP, Ortiz GG, Pacheco-Moises FP, Cardona-Munoz EG, Miranda-Diaz AG. Oxidants, antioxidants and mitochondrial function in non-proliferative diabetic retinopathy. J Diabetes. 2014 Mar;6(2):167-75. doi: 10.1111/1753-0407.12076. Epub 2013 Aug 21.
PubMed 23875878Rodriguez-Carrizalez AD, Castellanos-Gonzalez JA, Martinez-Romero EC, Miller-Arrevillaga G, Roman-Pintos LM, Pacheco-Moises FP, Miranda-Diaz AG. The antioxidant effect of ubiquinone and combined therapy on mitochondrial function in blood cells in non-proliferative diabetic retinopathy: A randomized, double-blind, phase IIa, placebo-controlled study. Redox Rep. 2016 Jul;21(4):190-5. doi: 10.1179/1351000215Y.0000000032. Epub 2016 Feb 5.
PubMed 26207797Rodriguez-Carrizalez AD, Castellanos-Gonzalez JA, Martinez-Romero EC, Miller-Arrevillaga G, Pacheco-Moises FP, Roman-Pintos LM, Miranda-Diaz AG. The effect of ubiquinone and combined antioxidant therapy on oxidative stress markers in non-proliferative diabetic retinopathy: A phase IIa, randomized, double-blind, and placebo-controlled study. Redox Rep. 2016 Jul;21(4):155-63. doi: 10.1179/1351000215Y.0000000040. Epub 2015 Aug 31.
PubMed 26321469Sonia Sifuentes-Franco, Adolfo Daniel Rodríguez-Carrizalez, Sandra Carrillo- Ibarra, José Alberto Castellanos-González, Esaú César Martínez-Romero, Guillermo Miller-Arrevillaga and Alejandra Guillermina Miranda-Díaz. The effect of Ubiquinone administration on oxidative DNA damage and repair in plasma levels in non-proliferative diabetic retinopathy.Diabetes Management 2017;7(2):186-191
Cecilia OM, Jose Alberto CG, Jose NP, Ernesto German CM, Ana Karen LC, Luis Miguel RP, Ricardo Raul RR, Adolfo Daniel RC. Oxidative Stress as the Main Target in Diabetic Retinopathy Pathophysiology. J Diabetes Res. 2019 Aug 14;2019:8562408. doi: 10.1155/2019/8562408. eCollection 2019.
PubMed 31511825Robles-Rivera RR, Castellanos-Gonzalez JA, Olvera-Montano C, Flores-Martin RA, Lopez-Contreras AK, Arevalo-Simental DE, Cardona-Munoz EG, Roman-Pintos LM, Rodriguez-Carrizalez AD. Adjuvant Therapies in Diabetic Retinopathy as an Early Approach to Delay Its Progression: The Importance of Oxidative Stress and Inflammation. Oxid Med Cell Longev. 2020 Mar 11;2020:3096470. doi: 10.1155/2020/3096470. eCollection 2020.
PubMed 32256949Lopez-Contreras AK, Martinez-Ruiz MG, Olvera-Montano C, Robles-Rivera RR, Arevalo-Simental DE, Castellanos-Gonzalez JA, Hernandez-Chavez A, Huerta-Olvera SG, Cardona-Munoz EG, Rodriguez-Carrizalez AD. Importance of the Use of Oxidative Stress Biomarkers and Inflammatory Profile in Aqueous and Vitreous Humor in Diabetic Retinopathy. Antioxidants (Basel). 2020 Sep 20;9(9):891. doi: 10.3390/antiox9090891.
PubMed 32962301
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Antioxidant Therapy on the Levels of Oxidative Stress Markers in Aqueous and Vitreous Humor of Patients With Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT04071977
- Acronym / sponsor ID
- RD-20180831
- Conditions
- Diabetic Retinopathy, Oxidative Stress, Diabetes
- Keywords
- Vitreous humor, Vitrectomy, Aqueous humor, Antioxidant therapy, Oxidative markers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Collaborators
- Hospital Civil de Guadalajara
- Study start
- 25 Mar 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 28 Aug 2019 (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.
The present study aims to support previous research on the effects of antioxidant therapy on the outcome of diabetic retinopathy and local oxidative stress values. The researchers intend to evaluate 56 patients with proliferative diabetic retinopathy undergoing the vitrectomy procedure, who will be assigned to a placebo group or combination antioxidant therapy. Each group will receive the intervention for 2 months. This intervention consists of taking one tablet (placebo or antioxidant therapy) orally, once a day.
At the beginning of the study, only blood samples will be collected to evaluate the state of oxidative and metabolic stress at a systemic level. After 2 months of intervention, blood samples will be taken again on the day of the intervention, adding the samples of aqueous and vitreous humor obtained during the vitrectomy. The results obtained between both groups and the different analysis matrices will be compared.
Detailed description
Diabetic retinopathy is a diabetes microvascular complication due to an insufficient oxygen supply to its endothelial cells in states of constant hyperglycemia. This entity is classified in two main categories: non-proliferative diabetic retinopathy and proliferative diabetic retinopathy, the latter is characterized for the presence of neovascularization as oppose to the first one.
Oxidative stress has been considered as one of the main factors in the development of diabetic retinopathy. It is a result from an imbalance between oxidants production and cellular antioxidant defenses, which provokes DNA damage.
The treatment of diabetic retinopathy simply includes glycemic, lipemic and blood pressure control. Only when the view is compromised is when a vitrectomy is performed, which usually occurs in the more advanced stages such as the proliferative stage. Antioxidant therapy has been used as a coadjuvant for these interventions, complementing the action and efficacy of the treatment established for diabetic retinopathy in the early stages. However, in order to obtain vitreous and aqueous humor, the vitrectomy procedure is required, which is only carried out in the proliferative stage.
Diabetic retinopathy is a specific and chronic complication of diabetes mellitus and is known to have a prevalence of 43.6% internationally and 31.5% in the Mexican population. It represents the main cause of visual blindness and weakness in the economically active population, which also affects the quality of life and the productivity of the people who suffer it.
The researchers intend to evaluate whether antioxidant therapy influences the levels of oxidative stress markers at the ocular level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Clinical trial phase IIa
| Arm | Type | Receives |
|---|---|---|
| Combined Antioxidant Therapy group | Active comparator | Drug: Combined antioxidant therapyThis arm will be administered with the combined antioxidant therapy, and will consist of 28 patients with proliferative diabetic retinopathy (PDR) who will undergo vitrectomy. |
| Placebo group | Placebo comparator | Other: PlaceboThis arm will be administered with placebo, and will consist of 28 patients with proliferative diabetic retinopathy (PDR) who will undergo vitrectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with type 2 with proliferative diabetic retinopathy
- Blood pressure under 160/100 mmHg
- HbA1c equal or lower than 9%
- LDL under 190mg/dl, triglycerides under 500mg/dl)
- Signed informed consent
Key exclusion criteria (12 listed)
- Vitreous hemorrhage for any cause other than Proliferative Diabetic Retinopathy complication
- Patients with vitrectomy surgery in the last 6 months
- Patients with laser surgery in the last 6 months
- Intravitreal application of antiangiogenic agents in the last 2 months
- Patients with other ocular pathologies such as age-related macular degeneration, glaucoma, endophthalmitis, conjunctivitis of any etiology, severe lacrimal film dysfunction syndrome, etc.
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 |
|---|---|---|
| Combined antioxidant therapyAlso: Drusen LazIt consists of a tablet with lutein (10 mg), astaxanthin (4 mg), Zeaxanthin (1 mg), vitamin C (L-ascorbic acid 180 mg), vitamin E (DL-alpha tocopherol 30 mg), zinc (zinc oxide 20 mg), copper (copper sulfate 1 mg), taken once a day for 12 months | Drug | Combined Antioxidant Therapy group |
| PlaceboAlso: MagnesiaIt consists in a capsule with 100 mg of magnesium oxide | Other | Placebo group |
Primary outcome
Compare levels of markers of oxidative stress in aqueous humor and vitreous humor
Time frame: 1 measure will be made after 2 months of intervention
The investigators will measure oxidative stress markers in aqueous and vitreous humor taken during vitrectomy procedure and compare such results between both intervention groups.
Changes in concentration of plasma 8-isoprostanes after intervention.
Time frame: 2 measures will be made, 1 at baseline, and one after completion of 2 months of intervention
The investigators will consider changes presented in plasma concentrations of 8-isoprostanes from baseline to the end of the intervention. The investigators expect to find a decrease in 8-isoprostanes concentrations in the supplemented group.
Changes in concentration of total antioxidant capacity (TAC) after intervention from baseline.
Time frame: 2 measures will be made, 1 at baseline, and one after completion of 2 months of intervention
The investigators will consider changes presented in plasma concentrations of total antioxidant capacity (TAC) from baseline to the end of the intervention. The investigators expect to find TAC augmentation in the supplemented group.
2 secondary outcomes
Correlate the levels of 8-isoprostanes in systemic samples, aqueous humor and vitreous humor with the glycosylated hemoglobin value of patients with proliferative diabetic retinopathy.
Time frame: 1 measure of glycated hemoglobin will be taken at baseline
Correlate the levels of total antioxidant capacity (TAC) in systemic samples, aqueous humor and vitreous humor with the glycosylated hemoglobin value of patients with proliferative diabetic retinopathy.
Time frame: 1 measure of glycated hemoglobin will be taken at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Background: PubMed 23875878Rodriguez-Carrizalez AD, Castellanos-Gonzalez JA, Martinez-Romero EC, Miller-Arrevillaga G, Villa-Hernandez D, Hernandez-Godinez PP, Ortiz GG, Pacheco-Moises FP, Cardona-Munoz EG, Miranda-Diaz AG. Oxidants, antioxidants and mitochondrial function in non-proliferative diabetic retinopathy. J Diabetes. 2014 Mar;6(2):167-75. doi: 10.1111/1753-0407.12076. Epub 2013 Aug 21.
- Background: PubMed 26207797Rodriguez-Carrizalez AD, Castellanos-Gonzalez JA, Martinez-Romero EC, Miller-Arrevillaga G, Roman-Pintos LM, Pacheco-Moises FP, Miranda-Diaz AG. The antioxidant effect of ubiquinone and combined therapy on mitochondrial function in blood cells in non-proliferative diabetic retinopathy: A randomized, double-blind, phase IIa, placebo-controlled study. Redox Rep. 2016 Jul;21(4):190-5. doi: 10.1179/1351000215Y.0000000032. Epub 2016 Feb 5.
- Background: PubMed 26321469Rodriguez-Carrizalez AD, Castellanos-Gonzalez JA, Martinez-Romero EC, Miller-Arrevillaga G, Pacheco-Moises FP, Roman-Pintos LM, Miranda-Diaz AG. The effect of ubiquinone and combined antioxidant therapy on oxidative stress markers in non-proliferative diabetic retinopathy: A phase IIa, randomized, double-blind, and placebo-controlled study. Redox Rep. 2016 Jul;21(4):155-63. doi: 10.1179/1351000215Y.0000000040. Epub 2015 Aug 31.
- BackgroundSonia Sifuentes-Franco, Adolfo Daniel Rodríguez-Carrizalez, Sandra Carrillo- Ibarra, José Alberto Castellanos-González, Esaú César Martínez-Romero, Guillermo Miller-Arrevillaga and Alejandra Guillermina Miranda-Díaz. The effect of Ubiquinone administration on oxidative DNA damage and repair in plasma levels in non-proliferative diabetic retinopathy.Diabetes Management 2017;7(2):186-191
- Background: PubMed 31511825Cecilia OM, Jose Alberto CG, Jose NP, Ernesto German CM, Ana Karen LC, Luis Miguel RP, Ricardo Raul RR, Adolfo Daniel RC. Oxidative Stress as the Main Target in Diabetic Retinopathy Pathophysiology. J Diabetes Res. 2019 Aug 14;2019:8562408. doi: 10.1155/2019/8562408. eCollection 2019.
- Background: PubMed 32256949Robles-Rivera RR, Castellanos-Gonzalez JA, Olvera-Montano C, Flores-Martin RA, Lopez-Contreras AK, Arevalo-Simental DE, Cardona-Munoz EG, Roman-Pintos LM, Rodriguez-Carrizalez AD. Adjuvant Therapies in Diabetic Retinopathy as an Early Approach to Delay Its Progression: The Importance of Oxidative Stress and Inflammation. Oxid Med Cell Longev. 2020 Mar 11;2020:3096470. doi: 10.1155/2020/3096470. eCollection 2020.
- Background: PubMed 32962301Lopez-Contreras AK, Martinez-Ruiz MG, Olvera-Montano C, Robles-Rivera RR, Arevalo-Simental DE, Castellanos-Gonzalez JA, Hernandez-Chavez A, Huerta-Olvera SG, Cardona-Munoz EG, Rodriguez-Carrizalez AD. Importance of the Use of Oxidative Stress Biomarkers and Inflammatory Profile in Aqueous and Vitreous Humor in Diabetic Retinopathy. Antioxidants (Basel). 2020 Sep 20;9(9):891. doi: 10.3390/antiox9090891.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combined antioxidant therapy in people with Diabetic Retinopathy and Oxidative Stress, run by University of Guadalajara at 1 site in Mexico.
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 9 inclusion and 12 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: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare levels of markers of oxidative stress in aqueous humor and vitreous humor (time frame: 1 measure will be made after 2 months of intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04071977, which also lists 7 linked publications.
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 1 Apr 2022.