Clinical Trials for Retinal Vein Occlusion
This article provides information about ongoing clinical trials for retinal vein occlusion, a condition where the veins carrying blood away from the retina become blocked, leading to vision problems. Currently, there are 4 clinical trials investigating various treatment approaches, including anti-VEGF medications like ranibizumab and aflibercept, administered as eye injections. These trials are being conducted across multiple European countries and aim to improve vision and reduce swelling in the eye caused by this condition.
Clinical trial locations
- Austria
- Bulgaria
- Czechia
- Estonia
- France
- Germany
- Hungary
- Italy
- Latvia
- Lithuania
- Poland
- Portugal
- Slovakia
- Spain
Study on Ranibizumab Injections and Laser Treatment for Macular Edema in Central Retinal Vein Occlusion Patients
This trial focuses on treating macular edema caused by central retinal vein occlusion. Macular edema occurs when fluid builds up in the macula, the part of the eye responsible for sharp vision, which can lead to blurred or distorted vision. This trial is testing whether combining ranibizumab injections with an early laser treatment called targeted peripheral laser photocoagulation can reduce the number of injections needed over time.
Inclusion criteria: To participate, patients must be at least 18 years old and have a confirmed diagnosis of macular edema due to central retinal vein occlusion that started within the last six months. The thickness of the macula must measure more than 250 micrometers on an OCT scan, and vision must be between 20/320 and 20/25. Patients must also show areas in their peripheral retina where blood flow is reduced. Written informed consent and the ability to attend all scheduled visits are required.
Exclusion criteria: Patients who do not have macular edema caused by central retinal vein occlusion cannot participate. The trial also excludes vulnerable populations, such as children, pregnant women, or individuals requiring special care, as well as those outside the specified age range.
Main focus: The trial aims to determine whether adding early laser treatment to regular ranibizumab injections can lead to a treatment-free period of at least six months. Participants will receive three initial monthly injections, followed by additional injections as needed based on their response. Some participants will also receive the laser treatment to target areas with poor blood flow. Regular follow-up visits will monitor vision and macula thickness throughout the study, which continues until 2026.
Investigational drugs: Ranibizumab is an anti-VEGF medication injected into the eye to reduce swelling and improve vision by blocking proteins that cause abnormal blood vessel growth and leakage. The trial also uses targeted peripheral laser photocoagulation as a complementary therapy to stabilize the retina and reduce the need for frequent injections.
Study on the Effect of Aflibercept Injections in Patients with Central Retinal Vein Occlusion (CRVO) and Spontaneous Retinal Arterial Pulsations (SRAPs)
This trial investigates how the presence of spontaneous retinal arterial pulsations affects treatment outcomes in patients with central retinal vein occlusion who receive aflibercept injections. The condition occurs when the main vein in the retina becomes blocked, causing fluid buildup and vision problems.
Inclusion criteria: Patients must be over 18 years old with a diagnosis of central retinal vein occlusion, with or without macular edema. Symptoms must have started within the last 30 days. Patients cannot have received previous intravitreal injections or corticosteroid implants. Women of childbearing age must use effective contraception during treatment and for three months after the last injection. Patients must be members of a health insurance scheme and sign an informed consent form.
Exclusion criteria: The trial excludes patients with other eye diseases that could interfere with study results, those who have had eye surgery in the last three months, individuals with uncontrolled high blood pressure, those with a history of severe allergic reactions, pregnant or breastfeeding women, people participating in other clinical trials, those with drug or alcohol abuse history, and patients with serious medical conditions that could interfere with the study or who cannot follow study procedures.
Main focus: The study monitors patients over one year to assess changes in vision, the number of aflibercept injections needed, and changes in macular thickness measured by OCT imaging. Researchers aim to understand whether spontaneous retinal arterial pulsations can predict treatment outcomes and help improve treatment strategies for this condition.
Investigational drugs: Aflibercept is administered as an eye injection to block proteins that cause abnormal blood vessel growth and leakage, helping to reduce swelling and improve or stabilize vision in patients with central retinal vein occlusion.
Study on the Effectiveness and Safety of Aflibercept for Patients with Vision Loss Due to Macular Edema from Retinal Vein Blockage
This trial compares two different dosing schedules of aflibercept for treating macular edema caused by retinal vein occlusion. Researchers want to determine if a higher dose given less frequently is as effective as a lower dose given more often.
Inclusion criteria: Adults aged 18 or older with new, untreated macular edema caused by branch, hemiretinal, or central retinal vein occlusion diagnosed within the last 16 weeks can participate. Vision must measure between 73 and 24 on the ETDRS letter score, and the thickness of the macula must be at least 300 micrometers (excluding Bruch’s membrane) or 320 micrometers (including it) on OCT. Participants must sign an informed consent form and agree to use effective birth control during treatment and for four months afterward if they can become pregnant or father a child.
Exclusion criteria: The trial excludes patients with other eye diseases that could affect vision, those who have had eye surgery in the last three months, individuals with eye infections, those allergic to the study medication or its ingredients, pregnant or breastfeeding women, people with uncontrolled high blood pressure, those who have had a stroke or heart attack in the last six months, participants in other clinical trials, and individuals with serious illnesses that could affect their ability to participate.
Main focus: One group receives 8 mg of aflibercept every eight weeks, while another receives 2 mg every four weeks. The trial monitors vision changes over time using the ETDRS letter score and tracks the number of injections and any side effects. Regular follow-up visits occur every four to eight weeks to assess treatment response and retinal health.
Investigational drugs: Aflibercept is a protein-based medication injected into the eye to reduce swelling and improve vision by blocking proteins that cause abnormal blood vessel growth and fluid leakage in macular edema caused by retinal vein occlusion.
Study on the Safety and Use of AVT06 (Aflibercept) for Patients with Chorioretinal Vascular Diseases
This trial studies the handling and safety of a pre-filled syringe version of aflibercept called AVT06 for treating various eye conditions involving blood vessel problems, including retinal vein occlusion. The trial includes an optional extension phase for further observation.
Inclusion criteria: Participants must be at least 18 years old with a diagnosis of neovascular age-related macular degeneration, diabetic macular edema, retinal vein occlusion, diabetic retinopathy, or myopic choroidal neovascularization in the study eye. The study doctor must determine that the eye is suitable for aflibercept treatment. Participants or their legal representatives must read, understand, and sign a consent form and be willing and able to follow all study procedures. Males must use contraception and not donate sperm during treatment and for three months after the last injection. Females must not be pregnant, breastfeeding, or planning pregnancy during this period and must not donate or store eggs for reproduction.
Exclusion criteria: The trial excludes patients with eye diseases not related to blood vessel problems, those who have had recent eye surgery or plan to have surgery during the study, individuals with eye infections or inflammation, people allergic to study medications or ingredients, those participating in other clinical trials, individuals with serious illnesses affecting study participation, pregnant or breastfeeding women, people with drug or alcohol abuse history, and those unable to follow study instructions or attend required visits.
Main focus: The trial evaluates whether the pre-filled syringe can be handled appropriately and safely for administering aflibercept as an eye injection. Researchers monitor patients for side effects and adverse events related to the eye from baseline to week four, assessing the proportion of successful injections and any ocular side effects.
Investigational drugs: AVT06 is a pre-filled syringe version of aflibercept, an anti-angiogenic agent that targets pathways involved in abnormal blood vessel growth and leakage in the retina, helping to reduce vision loss in patients with chorioretinal vascular diseases.
Summary
The four ongoing clinical trials for retinal vein occlusion are concentrated primarily in European countries, with the largest trial spanning 14 countries including Germany, Austria, France, Spain, and Italy. Three of the four trials focus on aflibercept as the investigational medication, while one trial examines ranibizumab combined with laser treatment. All trials use intravitreal injections, which are administered directly into the eye, as the method of drug delivery.
A notable observation is the emphasis on anti-VEGF medications, which work by blocking proteins that cause abnormal blood vessel growth and fluid leakage. The trials explore different dosing schedules and combinations with laser therapy to determine the most effective treatment approaches while potentially reducing the number of injections needed. Most trials require participants to have recent onset of the condition, typically within the last few weeks to six months, and exclude patients with other eye diseases or recent eye surgeries.
The trials monitor various outcomes including changes in vision measured by standardized letter scores, retinal thickness assessed through OCT imaging, and the number of injections required over time. These studies aim to provide evidence for optimizing treatment strategies for patients suffering from vision loss due to retinal vein occlusion.
