NCT04742829

Brief Summary

Evaluation of the effect of a therapy with INTRAVIT® tablets, on retinal edema considering also the central retinal sensitivity (Microperimetry) and the visual acuity in course of diabetic retinopathy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2021

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

January 29, 2021

Last Update Submit

February 3, 2021

Conditions

Diabetic Retinopathy

Keywords

diabetic retinopathymacula edemamicroperimetrycurcuminartemisinpiperinebromelain

Outcome Measures

Primary Outcomes (4)

  • number of participants with signs of improvement/worsening of diabetic retinopathy

    report presence/absence of signs with Yes/NO relative to: microaneurysms, haemorrhages, soft exudates, hard exudates, venous beading, IRMA, new vessels on optical discs, new vessels outside the optical discs, cystoid edema, capillary occlusions, degenerative alterations and vein size.

    6 months

  • number of participants in a certain stage of diabetic retinopathy according to the ETDRS modified AAO 2003

    careful evaluation of funduscopic signs (e.g exudates, neovases, micronaneurysms) to be able to stadiate patients

    6 months

  • number of patients with improved/worsened visual acuity

    visual acuity measurement with ETDRS boards. The number of letters seen by the patient at each check-up visit will be noted.

    6 months

  • number of patients with improved/worsened macular edema

    Foveal thickness (measured with Optical Coherence Tomography) at each check-up visit will be noted.

    6 months

Secondary Outcomes (1)

  • number of patients with improved/worsened blood parameters related to diabetes

    6 months

Study Arms (2)

GROUP 1

EXPERIMENTAL

Patients treated with INTRAVIT® tablets

Dietary Supplement: INTRAVIT ®

GROUP 2

NO INTERVENTION

patients who will not take any medical therapy to overlap with the activity described for INTRAVIT® tablets.

Interventions

INTRAVIT ®DIETARY_SUPPLEMENT

2 tablets per day morning and evening before meals

GROUP 1

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes type I and type II patients;
  • Between 20 and 70 years of age;
  • Age of diabetes not less than 5 years and not more than 15;
  • Mild non-proliferating diabetic retinopathy, limited to the presence of some microaneurysms;
  • Patients in diabetic compensation;
  • Visual acuity 5/10 natural or correct;
  • Patients even if hypertensive, with or without anti-hypertensive therapy in place, provided they are compensated;
  • Patients with good visualization of the ocular fundus.

You may not qualify if:

  • Patients with concurrent eye diseases outside diabetic retinopathy;
  • Patients with less than natural or correct 5/10 visual acuity;
  • Patients treated with other vasoprotective and antioxidant preparations or having taken them in the last month;
  • Patients with significant systemic or metabolic diseases, except diabetes;
  • Patients with unbalanced Diabetes disorder;
  • Patients undergoing laser treatment or eye surgery (e.g. cataract);
  • Patients who take or should take, during the observation period, preparations for direct or indirect activity on the retina of the type that can be superimposed on INTRAVIT ®.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Molise

Campobasso, Italy

Location

Related Publications (10)

  • Wang W, Lo ACY. Diabetic Retinopathy: Pathophysiology and Treatments. Int J Mol Sci. 2018 Jun 20;19(6):1816. doi: 10.3390/ijms19061816.

    PMID: 29925789RESULT

  • 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

  • Yang F, Yu J, Ke F, Lan M, Li D, Tan K, Ling J, Wang Y, Wu K, Li D. Curcumin Alleviates Diabetic Retinopathy in Experimental Diabetic Rats. Ophthalmic Res. 2018;60(1):43-54. doi: 10.1159/000486574. Epub 2018 Mar 29.

    PMID: 29597206RESULT

  • Radomska-Lesniewska DM, Osiecka-Iwan A, Hyc A, Gozdz A, Dabrowska AM, Skopinski P. Therapeutic potential of curcumin in eye diseases. Cent Eur J Immunol. 2019;44(2):181-189. doi: 10.5114/ceji.2019.87070. Epub 2019 Jul 30.

    PMID: 31530988RESULT

  • Mohr T, Desser L. Plant proteolytic enzyme papain abrogates angiogenic activation of human umbilical vein endothelial cells (HUVEC) in vitro. BMC Complement Altern Med. 2013 Sep 21;13:231. doi: 10.1186/1472-6882-13-231.

    PMID: 24053149RESULT

  • Al-Malki AL. Shikimic acid from Artemisia absinthium inhibits protein glycation in diabetic rats. Int J Biol Macromol. 2019 Feb 1;122:1212-1216. doi: 10.1016/j.ijbiomac.2018.09.072. Epub 2018 Sep 15.

    PMID: 30227208RESULT

  • Kumar S, Sharma S, Vasudeva N. Screening of antidiabetic and antihyperlipidemic potential of oil from Piper longum and piperine with their possible mechanism. Expert Opin Pharmacother. 2013 Sep;14(13):1723-36. doi: 10.1517/14656566.2013.815725. Epub 2013 Jul 23.

    PMID: 23875561RESULT

  • Pescosolido N, Giannotti R, Plateroti AM, Pascarella A, Nebbioso M. Curcumin: therapeutical potential in ophthalmology. Planta Med. 2014 Mar;80(4):249-54. doi: 10.1055/s-0033-1351074. Epub 2013 Dec 9.

    PMID: 24323538RESULT

  • Maugeri A, Mazzone MG, Giuliano F, Vinciguerra M, Basile G, Barchitta M, Agodi A. Curcumin Modulates DNA Methyltransferase Functions in a Cellular Model of Diabetic Retinopathy. Oxid Med Cell Longev. 2018 Jul 2;2018:5407482. doi: 10.1155/2018/5407482. eCollection 2018.

    PMID: 30057682RESULT

  • Wilkinson CP, Ferris FL 3rd, Klein RE, Lee PP, Agardh CD, Davis M, Dills D, Kampik A, Pararajasegaram R, Verdaguer JT; Global Diabetic Retinopathy Project Group. Proposed international clinical diabetic retinopathy and diabetic macular edema disease severity scales. Ophthalmology. 2003 Sep;110(9):1677-82. doi: 10.1016/S0161-6420(03)00475-5.

    PMID: 13129861RESULT

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Observational study, open, controlled between homogeneous groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor in Ophthalmology

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 8, 2021

Study Start

October 1, 2020

Primary Completion

March 8, 2021

Study Completion

March 8, 2021

Last Updated

February 8, 2021

Record last verified: 2021-02

Locations

IT(1)