Effects of a Therapy With INTRAVIT® Tablets in Patients With Diabetic Retinopathy (NCT04742829) | Clinical Trial Compass
UnknownNot Applicable
Effects of a Therapy With INTRAVIT® Tablets in Patients With Diabetic Retinopathy
Italy40 participantsStarted 2020-10-01
Plain-language 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.
Who can participate
Age range
20 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 ®.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
number of participants with signs of improvement/worsening of diabetic retinopathy
Timeframe: 6 months
2
number of participants in a certain stage of diabetic retinopathy according to the ETDRS modified AAO 2003
Timeframe: 6 months
3
number of patients with improved/worsened visual acuity
Timeframe: 6 months
4
number of patients with improved/worsened macular edema