Clinical trials – general information
Clinical trials are studies involving human subjects conducted to discover or confirm the effects of a drug (or type of therapy) in an investigated disease.
Clinical trials are designed to test whether a new treatment is safe and how effective it is. Through such trials, we discover new ways to prevent, diagnose and treat various diseases for which no effective treatment has been found so far.
The implementation of the entire research and development process for a new medicinal product consists of three stages: basic research, pre-clinical development and clinical trials. Simultaneous research is also carried out into the pharmaceutical form that the product will eventually take.
In order to definitively assess the suitability of a new substance for the treatment of a given condition, it is essential to carry out a series of clinical trials to confirm or verify data coming from various analyses, laboratory tests, etc.
To ensure the reliability of the data obtained from clinical trials, and to protect the welfare and rights of the subjects involved, all clinical trials are conducted in accordance with Good Clinical Practice (GCP).
Clinical trials of a new medicinal product are conducted in four phases. Each phase aims to obtain certain information. Each subsequent phase builds on the information obtained from a successfully completed previous phase. Patients may be eligible for a particular phase of a clinical trial depending on their condition, the type and severity of their disease, the type of treatment they are receiving, and what they have received so far.
In line with Good Clinical Practice, recruitment of participants for each phase of a clinical trial is carried out just before the trial, taking into account the inclusion and exclusion criteria detailed in the clinical trial protocol.
Clinical trials at the Retina Ophthalmological Outpatient Clinic and Hospital
At Retina, we conduct non-commercial clinical trials, i.e. clinical trials in which (in accordance with Article 37ia of the Act of 6 September 2001 – Pharmaceutical Law), the sponsor is the owner of the data obtained during the trial.
The sponsor may be an academic institution or another institution with rights to issue scientific titles, an investigator, patients organization, researchers organization, or any other natural or legal person whose activity is not aimed at making a profit.
Clinical trials – why we conduct them?
At Retina, we have chosen to participate in clinical trials for several reasons. We are primarily concerned with finding new treatments for our patients. We also want to see a continuous expansion of knowledge and development of clinical practice, an increase in Poland’s scientific stature in the field of medical sciences, and enhanced cooperation with European medical centres and medical companies where new treatments for complex health problems are developed. The more knowledgeable our medical team is, the more effectively we can treat our patients.
There is yet another reason, and it is equally important. At the Retina Ophthalmological Outpatient Clinic and Hospital we provide all medical services for a fee. However, we receive a lot of enquiries about free ophthalmic examinations, many requests for help with treatment or for discounts. Many patients choose not to receive treatment because they cannot afford to pay for it here, and they are not entitled to receive it under the insurance in the National Health Fund elsewhere. It refers, for example, to the treatment of exudative AMD (age-related macular degeneration). Clinical trials are therefore often the only option for patients to undertake treatment, because they do not pay for participation and receive real medical help.
The treatment of exudative AMD
Exudative (also known as wet) AMD, or age-related macular degeneration, is a chronic disease leading to severe visual impairment and eventually total blindness. The cause of exudative macular degeneration is still not completely clear, but we do know that, regrettably, at this moment the disease cannot be completely cured. Its progress can be, however, slowed down or stopped. There are some treatments available on the ophthalmic market which can result in improved vision in some patients. Unfortunately, these are paid, expensive treatments that require regular follow-up visits and a series of injections of anti-VEGF preparations administered into the eyeball. The price of one injection ranges from 800 to as much as 3,000 PLN.
In Poland receiving free treatment of AMD under the so-called drug programmes financed by the National Health Fund is possible, but they are not widely available and many patients have no chance to participate in them, so they give up treatment altogether.
What are the symptoms of exudative AMD?
Initially, in the first phase of the disease, patients find it more difficult to read, straight lines are distorted – they are curved or wavy, shapes or sizes of objects appear altered. Colours become paler and lack contrast. Other symptoms involve blurry arears in the central visual field and a significant reduction in visual acuity, e.g. when looking straight ahead.
In advanced stages of AMD a dark scotoma may appear in the centre of the visual field.
If you notice any of the above symptoms, see your ophthalmologist urgently.
Macular degeneration most commonly affects people with the following characteristics:
- over 50 years of age,
- with lightly-pigmented irises,
- with a family history of AMD,
- with obesity,
- with diabetes,
- with cardiovascular conditions,
- with hyperopia.
At the Retina Ophthalmological Outpatient Clinic and Hospital you can be screened for exudative AMD for a fee, or take part in one of the clinical trials for the treatment of this disease, free of charge.
Who is eligible for a free clinical trial for AMD?
Initially, the patient should meet the following inclusion criteria:
- be at least 50 years of age (female or male),
- be a citizen of Poland,
- not have been previously treated for exudative AMD with any intravitreal injections,
- not have participated in any other clinical trial,
- be able to understand and sign the terms and conditions for participation in the trial and any related documents,
- may have been initially diagnosed with fresh exudative AMD by another ophthalmologist.
Once a doctor from our centre confirms exudative (wet) AMD, the patient will be further advised on the possibility of taking part in a clinical trial. It will also be verified whether the patient meets the other specific inclusion and exclusion criteria of the trial (imposed externally by a Clinical Trial Protocol)
If the patent qualifies for the clinical trial, we will discuss the issues concerning their participation, such as medical procedures and appointment schedule.
If you have observed the above listed worrying symptoms of the disease, or you have already been diagnosed with exudative AMD, call our Clinical Trials Coordinators: