NCT04378972

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2019

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 7, 2020

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

May 4, 2020

Last Update Submit

May 6, 2020

Conditions

Diabetic Retinopathy

Keywords

neuroprotectionvitreouspro-inflammatory cytokinescurcuminvitamin D3homotaurine

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 days

Study Arms (2)

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.

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.

Other: control

Interventions

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.

TREATED GROUP
controlOTHER

ELISA tests on supernatants of 25 vitreous biopsies. The concentration of soluble mediators was calculated from a calibration curve.

CONTROL GROUP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

25 patients aged ≥18 years with diabetic retinopathy requiring vitrectomy

You may qualify if:

  • age ≥18 years
  • patients with diabetic retinopathy requiring vitrectomy
  • willingness to participate in the study following its indications

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Molise

Campobasso, Italy

Location

Related Publications (17)

  • 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.

    PMID: 10990036RESULT

  • Bringmann 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.

    PMID: 19660572RESULT

  • Cheung 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.

    PMID: 20580421RESULT

  • Antonetti 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.

    PMID: 22455417RESULT

  • Bringmann A, Wiedemann P. Muller glial cells in retinal disease. Ophthalmologica. 2012;227(1):1-19. doi: 10.1159/000328979. Epub 2011 Sep 15.

    PMID: 21921569RESULT

  • El-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.

    PMID: 22346117RESULT

  • Morescalchi 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.

    PMID: 24198445RESULT

  • dell'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.

    PMID: 23365490RESULT

  • Wu 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.

    PMID: 24379919RESULT

  • Cunha-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.

    PMID: 24680929RESULT

  • Grigsby 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.

    PMID: 25258680RESULT

  • Jenkins 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.

    PMID: 26676667RESULT

  • Semeraro 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.

    PMID: 26137497RESULT

  • Semeraro 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.

    PMID: 26173446RESULT

  • Bolinger 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.

    PMID: 27618014RESULT

  • Nawaz IM, Rezzola S, Cancarini A, Russo A, Costagliola C, Semeraro F, Presta M. Human vitreous in proliferative diabetic retinopathy: Characterization and translational implications. Prog Retin Eye Res. 2019 Sep;72:100756. doi: 10.1016/j.preteyeres.2019.03.002. Epub 2019 Apr 2.

    PMID: 30951889RESULT

  • Filippelli M, Campagna G, Vito P, Zotti T, Ventre L, Rinaldi M, Bartollino S, dell'Omo R, Costagliola C. Anti-inflammatory Effect of Curcumin, Homotaurine, and Vitamin D3 on Human Vitreous in Patients With Diabetic Retinopathy. Front Neurol. 2021 Feb 5;11:592274. doi: 10.3389/fneur.2020.592274. eCollection 2020.

    PMID: 33633656DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

human vitreous

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

CurcumintramiprosateCholecalciferol

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Ciro Costagliola, Full Professor

    University of Molise

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor in Ophthalmology

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 7, 2020

Study Start

September 16, 2019

Primary Completion

November 16, 2019

Study Completion

December 2, 2019

Last Updated

May 7, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)