Diabetic RetinopathyNCT04742829
Effects of a Therapy With INTRAVIT® Tablets in Patients With Diabetic Retinopathy
A study testing INTRAVIT ® in people with Diabetic Retinopathy, run by University of Molise at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- INTRAVIT ®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to 8 Mar 2021
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 ®.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of a Therapy With INTRAVIT® Tablets on Retinal Edema, Retinal Sensitivity and Visual Acuity in the Course of Diabetic Retinopathy
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.
Read the detailed description
Retinal edema is an abnormal accumulation of fluids in the retina, is a complication of certain eye diseases such as diabetic retinopathy, exudative macular degeneration, surgical or para - surgical practices and trauma. The main factors involved in the formation of retinal edema are due to structural alterations of blood vessels, formation of neovessels and phlogistic phenomena. INTRAVIT® is a product based on extracts of Artemisia, Turmeric, Pineapple and Black Pepper, formulated in a targeted way to support the treatment of retinal edema and treatments with intravitreal injections. Artemisia (artemisinin and its derivatives) has proven to be able to counteract the activity of VEGF, VEGFR, metal protein (MM2 and MMP9) and integrins αvβ3, all factors involved in the angiogenetic process. Turmeric (curcumin) has been shown to be able to counteract the phlogistic processes in various districts in addition to acting on the reduction of angiogenesis. The Pineapple (Bromelain) for its proteolytic activity has been able to favor the resorption of the edema and the reduction of the phlogistic phenomena. Black pepper (piperine) has proven to be able to counteract the phlogistic processes and encourage the bioavailability of some natural extracts such as curcumin.
The purpose of the study is to evaluate the effect of a therapy with INTRAVIT® tablets, on retinal edema considering also the central retinal sensitivity (Microperimetry) and visual acuity in the course of diabetic retinopathy. Diabetic patients with mild non-proliferant diabetic retinopathy (at an early stage) with macular edema will be enlisted. 40 patients, of which 20 will be treated with INTRAVIT® tablets (2 tablets per day morning and evening before meals), and 20 who will not take any medical therapy to overlap with the activity described for INTRAVIT® (control group). Patients covered by the inclusion criteria will undergo, before the start of treatment, a full eye examination and OCT (optical coherence tomography) for the measurement of foveal thickness. Based on the preordered randomization scheme they will be assigned to Group 1 or Group 2 (control group). Patients will undergo a first examination at the time of recruitment (T0), and subsequent visits (T1-T2) will fall to 3 and 6 months.The data collection sheet will report all adverse effects potentially attributable to the administration of the food supplement INTRAVIT® tablets.
- Conditions
- Diabetic Retinopathy
- Being tested
- INTRAVIT ®
- Keywords
- diabetic retinopathy, macula edema, microperimetry, curcumin, artemisin, piperine, bromelain
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTRAVIT ®Dietary supplement
2 tablets per day morning and evening before meals
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 | Experimental | Patients treated with INTRAVIT® tablets Receives: Dietary Supplement: INTRAVIT ® |
| GROUP 2 | No intervention | patients who will not take any medical therapy to overlap with the activity described for INTRAVIT® tablets. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
number of patients with improved/worsened blood parameters related to diabetes
blood sugar (mg/dl) using a rapid glucose test at each check-up visit will be noted and glycated hemoglobin (%) will be assesed with venous blood sampling at the beginning of the study and at 3 and 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start1 Oct 2020
- Primary completion8 Mar 2021 (estimated)
- Study completion8 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Observational study, open, controlled between homogeneous groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Molise
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciro Costagliola, University of Molise
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04742829
- Sponsor's protocol ID
- 09/2020
- Status last verified
- Feb 2021
- First submitted
- 29 Jan 2021
- Last updated
- 8 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang W, Lo ACY. Diabetic Retinopathy: Pathophysiology and Treatments. Int J Mol Sci. 2018 Jun 20;19(6):1816. doi: 10.3390/ijms19061816.
PubMed 29925789Cheung 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 20580421Yang 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.
PubMed 29597206Radomska-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.
PubMed 31530988Mohr 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.
PubMed 24053149Al-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.
PubMed 30227208Kumar 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.
PubMed 23875561Pescosolido 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.
PubMed 24323538Maugeri 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.
PubMed 30057682Wilkinson 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.
PubMed 13129861
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of a Therapy With INTRAVIT® Tablets on Retinal Edema, Retinal Sensitivity and Visual Acuity in the Course of Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT04742829
- Acronym / sponsor ID
- 09/2020
- Conditions
- Diabetic Retinopathy
- Keywords
- diabetic retinopathy, macula edema, microperimetry, curcumin, artemisin, piperine, bromelain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MoliseUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 8 Mar 2021 (estimated)
- Study completion
- 8 Mar 2021 (estimated)
- First posted
- 8 Feb 2021 (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.
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.
Detailed description
Retinal edema is an abnormal accumulation of fluids in the retina, is a complication of certain eye diseases such as diabetic retinopathy, exudative macular degeneration, surgical or para - surgical practices and trauma. The main factors involved in the formation of retinal edema are due to structural alterations of blood vessels, formation of neovessels and phlogistic phenomena. INTRAVIT® is a product based on extracts of Artemisia, Turmeric, Pineapple and Black Pepper, formulated in a targeted way to support the treatment of retinal edema and treatments with intravitreal injections. Artemisia (artemisinin and its derivatives) has proven to be able to counteract the activity of VEGF, VEGFR, metal protein (MM2 and MMP9) and integrins αvβ3, all factors involved in the angiogenetic process. Turmeric (curcumin) has been shown to be able to counteract the phlogistic processes in various districts in addition to acting on the reduction of angiogenesis. The Pineapple (Bromelain) for its proteolytic activity has been able to favor the resorption of the edema and the reduction of the phlogistic phenomena. Black pepper (piperine) has proven to be able to counteract the phlogistic processes and encourage the bioavailability of some natural extracts such as curcumin.
The purpose of the study is to evaluate the effect of a therapy with INTRAVIT® tablets, on retinal edema considering also the central retinal sensitivity (Microperimetry) and visual acuity in the course of diabetic retinopathy. Diabetic patients with mild non-proliferant diabetic retinopathy (at an early stage) with macular edema will be enlisted. 40 patients, of which 20 will be treated with INTRAVIT® tablets (2 tablets per day morning and evening before meals), and 20 who will not take any medical therapy to overlap with the activity described for INTRAVIT® (control group). Patients covered by the inclusion criteria will undergo, before the start of treatment, a full eye examination and OCT (optical coherence tomography) for the measurement of foveal thickness. Based on the preordered randomization scheme they will be assigned to Group 1 or Group 2 (control group). Patients will undergo a first examination at the time of recruitment (T0), and subsequent visits (T1-T2) will fall to 3 and 6 months.The data collection sheet will report all adverse effects potentially attributable to the administration of the food supplement INTRAVIT® tablets.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Observational study, open, controlled between homogeneous groups
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | Experimental | Dietary Supplement: INTRAVIT ®Patients treated with INTRAVIT® tablets |
| GROUP 2 | No intervention | –patients who will not take any medical therapy to overlap with the activity described for INTRAVIT® tablets. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| INTRAVIT ®2 tablets per day morning and evening before meals | Dietary supplement | GROUP 1 |
Primary outcome
number of participants with signs of improvement/worsening of diabetic retinopathy
Time frame: 6 months
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.
number of participants in a certain stage of diabetic retinopathy according to the ETDRS modified AAO 2003
Time frame: 6 months
careful evaluation of funduscopic signs (e.g exudates, neovases, micronaneurysms) to be able to stadiate patients
number of patients with improved/worsened visual acuity
Time frame: 6 months
visual acuity measurement with ETDRS boards. The number of letters seen by the patient at each check-up visit will be noted.
number of patients with improved/worsened macular edema
Time frame: 6 months
Foveal thickness (measured with Optical Coherence Tomography) at each check-up visit will be noted.
1 secondary outcome
number of patients with improved/worsened blood parameters related to diabetes
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Results publication: PubMed 29925789Wang W, Lo ACY. Diabetic Retinopathy: Pathophysiology and Treatments. Int J Mol Sci. 2018 Jun 20;19(6):1816. doi: 10.3390/ijms19061816.
- 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 29597206Yang 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.
- Results publication: PubMed 31530988Radomska-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.
- Results publication: PubMed 24053149Mohr 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.
- Results publication: PubMed 30227208Al-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.
- Results publication: PubMed 23875561Kumar 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.
- Results publication: PubMed 24323538Pescosolido 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.
- Results publication: PubMed 30057682Maugeri 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.
- Results publication: PubMed 13129861Wilkinson 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.
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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 study testing INTRAVIT ® in people with 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 8 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: status not confirmed, as of the sponsor's last update on 8 Feb 2021. 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?
Results are not available in the source record.
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?
number of participants with signs of improvement/worsening of diabetic retinopathy (time frame: 6 months). The study lists 4 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 NCT04742829, which also lists 10 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 8 Feb 2021.