Participation in Clinical Research
Clinical Research at “Latvian American Eye Center” Ltd
“Latvian American Eye Center” Ltd in partnership with different pharmaceutical companies participates in the clinical research projects and is one of the clinical research study sites.
Each study has its own inclusion and exclusion criteria, which determine the patient's eligibility and ability to participate in the study. There are a number of benefits to participating in a study, such as high-quality diagnostics and being under the medical supervision free of charge throughout the duration of the study, however, there are a number of risks and inconveniences involved too, such as having to arrive at the clinic for regular check-ups and appointments.
The patient's eligibility for the study is determined by the doctor, explaining alternative treatment options and agreeing with the patient on the most appropriate treatment method for the patient.
Before the patient can participate in the study, the patient is provided with detailed, written information about the study and participation in it, including the risks and benefits. If, after reviewing this information, the patient agrees to participate in the study, the patient and the physician sign an informed consent form to participate in the study.
In general, the aim of clinical research is to find new treatment solutions, improve knowledge of diseases, develop diagnostic methods and improve the technology of medical devices in order to provide the best possible medical care to patients. Clinical trials of medicinal products also aim to detect or test the clinical and pharmacological activity of the investigational product, adverse reactions to the investigational product, absorption and distribution in the body, metabolism, excretion, safety and overall efficacy.
Before starting a clinical trial, the investigator must obtain the permission of the State Agency of Medicines and the Ethics Committee for the implementation of the trial in Latvia.
The State Agency of Medicines evaluates the documentation of clinical trials, authorizes and supervises trials during the process, as well as assesses the compliance of trials with the principles of Good Clinical Practice.
A long and specific study path is required for the drug to reach the patient. Clinical trials are one stage in this journey, in which medicines are tested in medical settings on the specific patients. It has been studied in laboratories and in pre-clinical studies before being used in clinical trials.
There are 4 phases of Clinical Trials:
Phase I – it is studied how the drug is absorbed by the human body, how it is broken down and excreted from the body, Phase I studies include about 20-100 healthy volunteers, without pathologies;
Phase II - the most appropriate dose of the particular drug is studied, Phase II studies include 100-300 volunteers with the relevant disease;
Phase III - the effectiveness of the specific drug in the treatment of diseases is determined and compared to the current treatment on the market, Phase III studies include 300-3000 volunteers with the respective disease;
Phase IV - post-marketing surveillance, when the product is already available on the market, but long-term surveillance and research are ongoing.
"Latvian American Eye Center" is currently conducting several clinical trials for patients who have been diagnosed with one of the retinal diseases and have macular edema.
Patients with the following diagnoses are invited to apply for participation in the clinical trial:
1) Wet form of Age-Related Macular Degeneration
The retina is a fine and sensitive layer of tissue that lines the inner wall of the eyeball. A macula is a very small area in the center of the retina that provides the central part of the image. The disease causes abnormal vascular growth in the retina caused by vascular endothelial growth factor (VEGF). These blood vessels can be permeable and fluid can be released in the macula. This fluid accumulates and edema develops. This disease is common among the elderly - the older the age, the higher the risk of the disease. Age-related macular degeneration can also be inherited. Smoking and diets that lack certain important nutrients also significantly increase the risk of macular degeneration.
More information here.
2) Diabetic macular edema
Diabetic macular edema can develop in patients with diabetes. At the back of the eye – the retina, abnormal blood vessels growth is present. The growth of these blood vessels is promoted by vascular endothelial growth factor (VEGF) due to ischemia or lack of blood (oxygen). These blood vessels can be permeable, from which fluid is released in the macula, in the central part of the retina, fluid accumulates and edema develops.
More information here.
3) Retinal vein occlusion or thrombosis
In case of retinal vein occlusion or thrombosis, the central and / or peripheral blood vessels of the retina are blocked. It stops or interferes the blood flow from the retina, hemorrhages, neovascularization or growth of abnormal blood vessels under the influence of vascular endothelial growth factor (VEGF) can be formed. These newly formed blood vessels can be permeable, from which fluid is released in the macula, fluid accumulates and edema develops.
One of the main methods of treating the macular edema is the administration of an intravitreal drug, where the medication is injected directly into the eyeball. This drug therapy aims to inhibit vascular endothelial growth factor (VEGF) and is called Anti-VEGF therapy. To date, the most popular and used drugs for this purpose are Avastin (bevacizumab), Eylea (aflibercept) and Lucentis (ranibizumab). However, new, innovative and more effective medicines are currently being sought around the world. As a result, a number of clinical trials are currently underway around the world to investigate new and innovative products as well as biosimilars to already marketed products.
More information here.
Benefits from participation in the study:
1) high quality diagnostics free of charge;
2) being under the supervision of a doctor free of charge throughout the study period.
Possible risks and inconveniences:
1) potential risks have been identified for each specific study, however, it should be taken into account that the clinical trial process may also reveal previously unidentified risks (before the patient participates in the study, the physician informs the patient about all risks associated with the particular study);
2) the patient must come to the clinic at regular times for check-ups and appointments.
To find out more information or to get in touch with our Clinical Research team please use one of the following options:
"Latvian American Eye Center" has been engaged in clinical research projects since 2008 and considers it as an investment in development with the main goal of providing patients with the best treatment options.
The performance of clinical trials in Latvia is regulated by the Cabinet of Ministers Regulations No. 289 “Regulations Regarding the Procedures for Conduct of Clinical Trials and Non-interventional Trials of Medicinal Products, Labelling of Investigational Medicinal Products and the Procedures for Assessment of Conformity of Clinical Trial of Medicinal Products with the Requirements of Good Clinical Practice”.