Diabetic RetinopathyNCT04378972
Anti-inflammatory Effect of Curcumin, Homotaurine, Vitamin D3 on Human Vitreous in Patients With Diabetic Retinopathy
An observational study of Diabetic Retinopathy, run by University of Molise at 1 site in Italy.
Trial summary
Dosage of pro-inflammatory cytokines and soluble mediators (TNFα, IL6, IL2 and PDGF-AB) performed on 25 vitreous biopsies taken from patients with diabetic retinopathy and treated with increasing doses of curcumin (0.5uM and 1uM), with or without homotaurine (100uM) and vitamin D3 (50nM). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- curcumin, homotaurine, vitamin D3
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 16 Sep 2019to 2 Dec 2019
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 25 patients aged ≥18 years with diabetic retinopathy requiring vitrectomy
Who may be able to join
- age ≥18 years
- patients with diabetic retinopathy requiring vitrectomy
- willingness to participate in the study following its indications
Who cannot join
- previous vitrectomy in the study eye
- previous buckle surgery in the study eye
- previous intravitreal injection in the study eye
- concurrent retinovascular or other ocular inflammatory disease
- history of ocular trauma
- concomitant intake of any topical or systemic NSAID or corticosteroid therapy
- presence of systemic inflammations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Soluble Mediators of Inflammation and Angiogenesis in the Vitreous of Patients With Diabetic Retinopathy Treated With Curcumin/Homotaurine/Vit. D3
Dosage of pro-inflammatory cytokines and soluble mediators (TNFα, IL6, IL2 and PDGF-AB) performed on 25 vitreous biopsies taken from patients with diabetic retinopathy and treated with increasing doses of curcumin (0.5uM and 1uM), with or without homotaurine (100uM) and vitamin D3 (50nM).
Read the detailed description
Diabetic retinopathy is one of the most common complications of diabetes mellitus and is a leading cause of vision loss and blindness in the working-age population worldwide. DR is being recognized as a neurodegenerative disease of the retina as opposed to previously considered solely as a microvascular disease. Progressive blindness is due to the long-term accumulation of pathological abnormalities in the retina of hyperglycemic patients. In the initial phase, non-proliferative diabetic retinopathy (NPDR) is almost asymptomatic with the onset of microhemorrhagic and microischemic episodes and an increase in vascular permeability. Subsequently, the progression of the disease is accompanied by the onset of a chronic inflammatory state and neovascularization in a vicious circle that feeds and determines the accumulation of damage to the retina through hypoxia, oxidative stress and widespread neurodegeneration. Among metabolites, hyperglycemia is known to be the major factor which activates several metabolic pathways harmful for retina. Moreover, an increased level of glutamate has been reported in the diabetic retina and also in the vitreous of diabetic patients, suggesting a neurotoxic role of glutamate which may damage retinal neurons and especially retinal ganglion cells by excitotoxicity. In proliferative diabetic retinopathy (PDR), vitreous humor undergoes structural and molecular changes, with changes also in composition, which play a central role in supporting disease progression.The vitreous, 4 ml in volume, is a transparent gel-like structure which fills the space between the lens and the retina. It is composed of 98-99% of water with traces of cations, ions, proteins (mainly collagen) and polysaccharides such as hyaluronic acid. In PDR patients undergoing pars plana vitrectomy, vitreous samples are characterized by altered levels of bioactive molecules with pro-angiogenic, proinflammatory and neuromodulatory activities. So, it is clear that the vitreous acts as a reservoir of soluble signaling mediators that could exacerbate retinal damage. On the other hand, the vitreous obtained from patients with PDR can be a powerful tool to evaluate the anti-angiogenic / anti-inflammatory activity of new biomolecules that could be potential candidates for the treatment of diabetic vitreoretinopathy. Currently, PDR is treated with laser photocoagulation, vitreoretinal surgery or intravitreal injection of drugs targeted to the vascular endothelial growth factor (VEGF) and steroid agents.However, these protocols are effective in the short term, cause side effects and, above all, are indicated only for advanced stages of the disease. So, noninvasive, nondestructive, and longer-duration treatment options are also needed. Recently, research efforts have been made to identify neuroprotective drugs able to prevent visual field loss and preserve visual function and a promising alternative for the treatment of early-stage NPDR comes from nutraceuticals. In fact, in vitro and in vivo studies have revealed that a variety of nutraceuticals has important antioxidant and anti-inflammatory properties that can compromise the first diabetes-driven molecular events that cause vitreoretinopathy, acting upstream of the disease. Based on the results of several investigations, it is reasonable to assert that a single constituent that affects one target has limited efficacy in preventing the progression of multifactorial diseases. A large body of research revealed that the use of a combination of compounds with synergistic multitarget effects may offer a more powerful approach for disease prevention, including retinal neurodegeneration. In experimental models of retinal neurodegeneration it has been shown that cotreatment of citicoline and homotaurine has a direct neuroprotective effect on primary retinal cells exposed to glutamate toxicity and HG levels. Glutamate-induced excitotoxicity is implicated in the pathophysiology of several degenerative diseases of the retina, including glaucoma. Moreover, HG-induced neurotoxicity is a characteristic of diabetic retinopathy. Curcumin, a yellowish non-flavonoid polyphenol that constitutes the main active compound of Curcuma longa, is widely known for its antioxidant and anti-inflammatory properties . Many studies have also described its marked protective effect on retinal cells against oxidative stress and inflammation. Lastly, vitamin D levels appeared to be lower in diabetes mellitus type 2 patients and this could have therapeutic implications. Therefore, the aim of the investigator's study is to analyze the soluble mediators of inflammation and angiogenesis in the vitreous of patients with diabetic retinopathy treated with homotaurine, curcumin and vitamin D3.
- Conditions
- Diabetic Retinopathy
- Being tested
- curcumin, homotaurine, vitamin D3, control
- Keywords
- neuroprotection, vitreous, pro-inflammatory cytokines, curcumin, vitamin D3, homotaurine
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curcumin, homotaurine, vitamin D3Other
ELISA tests on supernatants of 25 vitreous biopsies incubated with bioactive molecules at 37 ° C for 20 h. The concentration of soluble mediators was calculated from a calibration curve.
controlOther
ELISA tests on supernatants of 25 vitreous biopsies. The concentration of soluble mediators was calculated from a calibration curve.
| Study group | Role | What they receive |
|---|---|---|
| TREATED GROUP | 25 portions of vitreous samples from 25 eyes of patients operated on vitrectomy for complications from diabetic retinopathy, incubated with curcumin, homotaurine and vitamin D3. The substances will be used individually and in triple association, to evaluate a possible synergistic effect on the expression of inflammatory cytokines and endothelial growth factors. Receives: Other: curcumin, homotaurine, vitamin D3 | |
| CONTROL GROUP | The same fractions of vitreous samples (n = 25) evaluated for the expression of oxidative biomarkers, inflammatory cytokines and metalloproteinases, without prior incubation with the substances of the treated group. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
pro-inflammatory cytokines analysis
Evaluation of the anti-inflammatory effect of curcumin, homotaurine and vitamin D3 on the expression of inflammatory cytokines in human vitreous samples of patients suffering from diabetic retinopathy.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start16 Sep 2019
- Primary completion16 Nov 2019
- Study completion2 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Molise
- Sponsor type
- University, hospital or other
- Collaborators
- Humanitas Gradenigo - Torino, Cliniche Humanitas Gavazzeni, Consorzio Sannio Tech, University of Roma La Sapienza, FB VISION, Ascoli Piceno, Italy
- Responsible party
- Principal investigator, Ciro Costagliola, University of Molise
- Investigators
- Ciro Costagliola, Full Professor, Principal investigator, University of Molise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378972
- Sponsor's protocol ID
- 11/2019
- Status last verified
- May 2020
- First submitted
- 4 May 2020
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stefansson E, Bek T, Porta M, Larsen N, Kristinsson JK, Agardh E. Screening and prevention of diabetic blindness. Acta Ophthalmol Scand. 2000 Aug;78(4):374-85. doi: 10.1034/j.1600-0420.2000.078004374.x.
PubMed 10990036Bringmann A, Iandiev I, Pannicke T, Wurm A, Hollborn M, Wiedemann P, Osborne NN, Reichenbach A. Cellular signaling and factors involved in Muller cell gliosis: neuroprotective and detrimental effects. Prog Retin Eye Res. 2009 Nov;28(6):423-51. doi: 10.1016/j.preteyeres.2009.07.001. Epub 2009 Aug 4.
PubMed 19660572Cheung N, Mitchell P, Wong TY. Diabetic retinopathy. Lancet. 2010 Jul 10;376(9735):124-36. doi: 10.1016/S0140-6736(09)62124-3. Epub 2010 Jun 26.
PubMed 20580421Antonetti DA, Klein R, Gardner TW. Diabetic retinopathy. N Engl J Med. 2012 Mar 29;366(13):1227-39. doi: 10.1056/NEJMra1005073. No abstract available.
PubMed 22455417Bringmann A, Wiedemann P. Muller glial cells in retinal disease. Ophthalmologica. 2012;227(1):1-19. doi: 10.1159/000328979. Epub 2011 Sep 15.
PubMed 21921569El-Asrar AM. Role of inflammation in the pathogenesis of diabetic retinopathy. Middle East Afr J Ophthalmol. 2012 Jan;19(1):70-4. doi: 10.4103/0974-9233.92118.
PubMed 22346117Morescalchi F, Duse S, Gambicorti E, Romano MR, Costagliola C, Semeraro F. Proliferative vitreoretinopathy after eye injuries: an overexpression of growth factors and cytokines leading to a retinal keloid. Mediators Inflamm. 2013;2013:269787. doi: 10.1155/2013/269787. Epub 2013 Sep 30.
PubMed 24198445dell'Omo R, Semeraro F, Bamonte G, Cifariello F, Romano MR, Costagliola C. Vitreous mediators in retinal hypoxic diseases. Mediators Inflamm. 2013;2013:935301. doi: 10.1155/2013/935301. Epub 2013 Jan 10.
PubMed 23365490Wu L, Fernandez-Loaiza P, Sauma J, Hernandez-Bogantes E, Masis M. Classification of diabetic retinopathy and diabetic macular edema. World J Diabetes. 2013 Dec 15;4(6):290-4. doi: 10.4239/wjd.v4.i6.290.
PubMed 24379919Cunha-Vaz J, Ribeiro L, Lobo C. Phenotypes and biomarkers of diabetic retinopathy. Prog Retin Eye Res. 2014 Jul;41:90-111. doi: 10.1016/j.preteyeres.2014.03.003. Epub 2014 Mar 26.
PubMed 24680929Grigsby JG, Cardona SM, Pouw CE, Muniz A, Mendiola AS, Tsin AT, Allen DM, Cardona AE. The role of microglia in diabetic retinopathy. J Ophthalmol. 2014;2014:705783. doi: 10.1155/2014/705783. Epub 2014 Aug 31.
PubMed 25258680Jenkins AJ, Joglekar MV, Hardikar AA, Keech AC, O'Neal DN, Januszewski AS. Biomarkers in Diabetic Retinopathy. Rev Diabet Stud. 2015 Spring-Summer;12(1-2):159-95. doi: 10.1900/RDS.2015.12.159. Epub 2015 Aug 10.
PubMed 26676667Semeraro F, Cancarini A, dell'Omo R, Rezzola S, Romano MR, Costagliola C. Diabetic Retinopathy: Vascular and Inflammatory Disease. J Diabetes Res. 2015;2015:582060. doi: 10.1155/2015/582060. Epub 2015 Jun 7.
PubMed 26137497Semeraro F, Russo A, Gambicorti E, Duse S, Morescalchi F, Vezzoli S, Costagliola C. Efficacy and vitreous levels of topical NSAIDs. Expert Opin Drug Deliv. 2015;12(11):1767-82. doi: 10.1517/17425247.2015.1068756. Epub 2015 Jul 14.
PubMed 26173446Bolinger MT, Antonetti DA. Moving Past Anti-VEGF: Novel Therapies for Treating Diabetic Retinopathy. Int J Mol Sci. 2016 Sep 7;17(9):1498. doi: 10.3390/ijms17091498.
PubMed 27618014
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Soluble Mediators of Inflammation and Angiogenesis in the Vitreous of Patients With Diabetic Retinopathy Treated With Curcumin/Homotaurine/Vit. D3
- ClinicalTrials.gov ID
- NCT04378972
- Acronym / sponsor ID
- 11/2019
- Conditions
- Diabetic Retinopathy
- Keywords
- neuroprotection, vitreous, pro-inflammatory cytokines, curcumin, vitamin D3, homotaurine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of MoliseUniversity, hospital or other
- Collaborators
- Humanitas Gradenigo - Torino, Cliniche Humanitas Gavazzeni, Consorzio Sannio Tech, University of Roma La Sapienza, FB VISION, Ascoli Piceno, Italy
- Study start
- 16 Sep 2019 (actual)
- Primary completion
- 16 Nov 2019 (actual)
- Study completion
- 2 Dec 2019 (actual)
- First posted
- 7 May 2020 (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.
Dosage of pro-inflammatory cytokines and soluble mediators (TNFα, IL6, IL2 and PDGF-AB) performed on 25 vitreous biopsies taken from patients with diabetic retinopathy and treated with increasing doses of curcumin (0.5uM and 1uM), with or without homotaurine (100uM) and vitamin D3 (50nM).
Detailed description
Diabetic retinopathy is one of the most common complications of diabetes mellitus and is a leading cause of vision loss and blindness in the working-age population worldwide. DR is being recognized as a neurodegenerative disease of the retina as opposed to previously considered solely as a microvascular disease. Progressive blindness is due to the long-term accumulation of pathological abnormalities in the retina of hyperglycemic patients. In the initial phase, non-proliferative diabetic retinopathy (NPDR) is almost asymptomatic with the onset of microhemorrhagic and microischemic episodes and an increase in vascular permeability. Subsequently, the progression of the disease is accompanied by the onset of a chronic inflammatory state and neovascularization in a vicious circle that feeds and determines the accumulation of damage to the retina through hypoxia, oxidative stress and widespread neurodegeneration. Among metabolites, hyperglycemia is known to be the major factor which activates several metabolic pathways harmful for retina. Moreover, an increased level of glutamate has been reported in the diabetic retina and also in the vitreous of diabetic patients, suggesting a neurotoxic role of glutamate which may damage retinal neurons and especially retinal ganglion cells by excitotoxicity. In proliferative diabetic retinopathy (PDR), vitreous humor undergoes structural and molecular changes, with changes also in composition, which play a central role in supporting disease progression.The vitreous, 4 ml in volume, is a transparent gel-like structure which fills the space between the lens and the retina. It is composed of 98-99% of water with traces of cations, ions, proteins (mainly collagen) and polysaccharides such as hyaluronic acid. In PDR patients undergoing pars plana vitrectomy, vitreous samples are characterized by altered levels of bioactive molecules with pro-angiogenic, proinflammatory and neuromodulatory activities. So, it is clear that the vitreous acts as a reservoir of soluble signaling mediators that could exacerbate retinal damage. On the other hand, the vitreous obtained from patients with PDR can be a powerful tool to evaluate the anti-angiogenic / anti-inflammatory activity of new biomolecules that could be potential candidates for the treatment of diabetic vitreoretinopathy. Currently, PDR is treated with laser photocoagulation, vitreoretinal surgery or intravitreal injection of drugs targeted to the vascular endothelial growth factor (VEGF) and steroid agents.However, these protocols are effective in the short term, cause side effects and, above all, are indicated only for advanced stages of the disease. So, noninvasive, nondestructive, and longer-duration treatment options are also needed. Recently, research efforts have been made to identify neuroprotective drugs able to prevent visual field loss and preserve visual function and a promising alternative for the treatment of early-stage NPDR comes from nutraceuticals. In fact, in vitro and in vivo studies have revealed that a variety of nutraceuticals has important antioxidant and anti-inflammatory properties that can compromise the first diabetes-driven molecular events that cause vitreoretinopathy, acting upstream of the disease. Based on the results of several investigations, it is reasonable to assert that a single constituent that affects one target has limited efficacy in preventing the progression of multifactorial diseases. A large body of research revealed that the use of a combination of compounds with synergistic multitarget effects may offer a more powerful approach for disease prevention, including retinal neurodegeneration. In experimental models of retinal neurodegeneration it has been shown that cotreatment of citicoline and homotaurine has a direct neuroprotective effect on primary retinal cells exposed to glutamate toxicity and HG levels. Glutamate-induced excitotoxicity is implicated in the pathophysiology of several degenerative diseases of the retina, including glaucoma. Moreover, HG-induced neurotoxicity is a characteristic of diabetic retinopathy. Curcumin, a yellowish non-flavonoid polyphenol that constitutes the main active compound of Curcuma longa, is widely known for its antioxidant and anti-inflammatory properties . Many studies have also described its marked protective effect on retinal cells against oxidative stress and inflammation. Lastly, vitamin D levels appeared to be lower in diabetes mellitus type 2 patients and this could have therapeutic implications. Therefore, the aim of the investigator's study is to analyze the soluble mediators of inflammation and angiogenesis in the vitreous of patients with diabetic retinopathy treated with homotaurine, curcumin and vitamin D3.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TREATED GROUP | – | Other: curcumin, homotaurine, vitamin D325 portions of vitreous samples from 25 eyes of patients operated on vitrectomy for complications from diabetic retinopathy, incubated with curcumin, homotaurine and vitamin D3. The substances will be used individually and in triple association, to evaluate a possible synergistic effect on the expression of inflammatory cytokines and endothelial growth factors. |
| CONTROL GROUP | – | Other: controlThe same fractions of vitreous samples (n = 25) evaluated for the expression of oxidative biomarkers, inflammatory cytokines and metalloproteinases, without prior incubation with the substances of the treated group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 25 patients aged ≥18 years with diabetic retinopathy requiring vitrectomy
Key inclusion criteria (3 listed)
- age ≥18 years
- patients with diabetic retinopathy requiring vitrectomy
- willingness to participate in the study following its indications
Key exclusion criteria (7 listed)
- previous vitrectomy in the study eye
- previous buckle surgery in the study eye
- previous intravitreal injection in the study eye
- concurrent retinovascular or other ocular inflammatory disease
- history of ocular trauma
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 |
|---|---|---|
| curcumin, homotaurine, vitamin D3ELISA tests on supernatants of 25 vitreous biopsies incubated with bioactive molecules at 37 ° C for 20 h. The concentration of soluble mediators was calculated from a calibration curve. | Other | TREATED GROUP |
| controlELISA tests on supernatants of 25 vitreous biopsies. The concentration of soluble mediators was calculated from a calibration curve. | Other | CONTROL GROUP |
Primary outcome
pro-inflammatory cytokines analysis
Time frame: 7 days
Evaluation of the anti-inflammatory effect of curcumin, homotaurine and vitamin D3 on the expression of inflammatory cytokines in human vitreous samples of patients suffering from diabetic retinopathy.
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 7 May 2020.
- Results publication: PubMed 10990036Stefansson E, Bek T, Porta M, Larsen N, Kristinsson JK, Agardh E. Screening and prevention of diabetic blindness. Acta Ophthalmol Scand. 2000 Aug;78(4):374-85. doi: 10.1034/j.1600-0420.2000.078004374.x.
- Results publication: PubMed 19660572Bringmann A, Iandiev I, Pannicke T, Wurm A, Hollborn M, Wiedemann P, Osborne NN, Reichenbach A. Cellular signaling and factors involved in Muller cell gliosis: neuroprotective and detrimental effects. Prog Retin Eye Res. 2009 Nov;28(6):423-51. doi: 10.1016/j.preteyeres.2009.07.001. Epub 2009 Aug 4.
- Results publication: PubMed 20580421Cheung N, Mitchell P, Wong TY. Diabetic retinopathy. Lancet. 2010 Jul 10;376(9735):124-36. doi: 10.1016/S0140-6736(09)62124-3. Epub 2010 Jun 26.
- Results publication: PubMed 22455417Antonetti DA, Klein R, Gardner TW. Diabetic retinopathy. N Engl J Med. 2012 Mar 29;366(13):1227-39. doi: 10.1056/NEJMra1005073. No abstract available.
- Results publication: PubMed 21921569Bringmann A, Wiedemann P. Muller glial cells in retinal disease. Ophthalmologica. 2012;227(1):1-19. doi: 10.1159/000328979. Epub 2011 Sep 15.
- Results publication: PubMed 22346117El-Asrar AM. Role of inflammation in the pathogenesis of diabetic retinopathy. Middle East Afr J Ophthalmol. 2012 Jan;19(1):70-4. doi: 10.4103/0974-9233.92118.
- Results publication: PubMed 24198445Morescalchi F, Duse S, Gambicorti E, Romano MR, Costagliola C, Semeraro F. Proliferative vitreoretinopathy after eye injuries: an overexpression of growth factors and cytokines leading to a retinal keloid. Mediators Inflamm. 2013;2013:269787. doi: 10.1155/2013/269787. Epub 2013 Sep 30.
- Results publication: PubMed 23365490dell'Omo R, Semeraro F, Bamonte G, Cifariello F, Romano MR, Costagliola C. Vitreous mediators in retinal hypoxic diseases. Mediators Inflamm. 2013;2013:935301. doi: 10.1155/2013/935301. Epub 2013 Jan 10.
- Results publication: PubMed 24379919Wu L, Fernandez-Loaiza P, Sauma J, Hernandez-Bogantes E, Masis M. Classification of diabetic retinopathy and diabetic macular edema. World J Diabetes. 2013 Dec 15;4(6):290-4. doi: 10.4239/wjd.v4.i6.290.
- Results publication: PubMed 24680929Cunha-Vaz J, Ribeiro L, Lobo C. Phenotypes and biomarkers of diabetic retinopathy. Prog Retin Eye Res. 2014 Jul;41:90-111. doi: 10.1016/j.preteyeres.2014.03.003. Epub 2014 Mar 26.
- Results publication: PubMed 25258680Grigsby JG, Cardona SM, Pouw CE, Muniz A, Mendiola AS, Tsin AT, Allen DM, Cardona AE. The role of microglia in diabetic retinopathy. J Ophthalmol. 2014;2014:705783. doi: 10.1155/2014/705783. Epub 2014 Aug 31.
- Results publication: PubMed 26676667Jenkins AJ, Joglekar MV, Hardikar AA, Keech AC, O'Neal DN, Januszewski AS. Biomarkers in Diabetic Retinopathy. Rev Diabet Stud. 2015 Spring-Summer;12(1-2):159-95. doi: 10.1900/RDS.2015.12.159. Epub 2015 Aug 10.
- 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.
Ciro Costagliola, Full Professor principal investigator
University of Molise
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by University of Molise at 1 site in Italy.
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 3 inclusion and 7 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 7 May 2020. 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 Italy. 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.
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?
pro-inflammatory cytokines analysis (time frame: 7 days). 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 NCT04378972, which also lists 17 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 7 May 2020.