This clinical trial is focused on studying a condition called macular edema, which is a swelling in the central part of the retina, known as the macula. This swelling is caused by a blocked vein in the retina, a condition referred to as retinal vein occlusion. The study is investigating the effectiveness and safety of a medication called aflibercept, which is given as an injection into the eye. Aflibercept is a protein-based treatment that helps reduce swelling and improve vision.
The purpose of the study is to compare two different doses of aflibercept. One group of participants will receive 8 mg of aflibercept every 8 weeks, while another group will receive 2 mg every 4 weeks. The study aims to determine if the higher dose given less frequently is as effective as the lower dose given more frequently. Participants will receive injections over a period of time, and their vision will be monitored to see how it changes with the treatment.
Throughout the study, participants will have their vision tested using a method called the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score, which measures how well they can see letters on a chart. The study will also track the number of injections participants receive and any side effects they may experience. The goal is to find the best treatment option for improving vision in people with macular edema due to retinal vein occlusion.
1initial visit
Upon joining the study, the first step involves an initial visit to the clinic. During this visit, a comprehensive eye examination is conducted to confirm eligibility for the trial. This includes measuring the best-corrected visual acuity (BCVA) and assessing the thickness of the retina using a special imaging technique called optical coherence tomography (OCT).
2randomization and first treatment
Participants are randomly assigned to one of two treatment groups. One group receives aflibercept 8 mg every 8 weeks, while the other group receives aflibercept 2 mg every 4 weeks. The medication is administered as an injection directly into the eye, a procedure known as intravitreal use.
3follow-up visits
Regular follow-up visits are scheduled to monitor the response to treatment and any side effects. These visits occur every 4 to 8 weeks, depending on the assigned treatment group. During these visits, the same eye examinations are repeated to track changes in vision and retinal thickness.
4midpoint assessment
At approximately 36 weeks into the study, a detailed assessment is conducted to evaluate changes in vision and retinal condition. This includes measuring the change in BCVA and checking for any fluid in the retina.
5continuation of treatment
Treatment continues as per the assigned schedule, with ongoing monitoring and assessments at each visit. Adjustments to the treatment schedule may be made based on the participant’s response and the study protocol.
6final assessment
At the end of the study period, around 64 weeks, a final assessment is conducted. This includes a comprehensive evaluation of vision, retinal health, and any side effects experienced during the trial.
Who Can Join the Study?
Must be an adult aged 18 years or older (or the legal age of adulthood in your country if it is higher).
Must have macular edema (swelling in the back of the eye) that is new and has not been treated before, caused by a blockage in the veins of the retina (the light-sensitive layer at the back of the eye). This includes branch, hemiretinal, or central retinal vein occlusion, diagnosed within the last 16 weeks.
Must have a specific range of vision ability, measured by a test called the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA letter score, between 73 and 24 (equivalent to 20/40 to 20/320 vision) in the affected eye.
The decrease in vision must be mainly due to the vein blockage in the affected eye.
Must have a certain level of central subfield thickness (CST) in the retina, measured by a scan called optical coherence tomography (OCT). This thickness should be 300 micrometers or more if excluding a layer called Bruch’s membrane, or 320 micrometers or more if including it.
Must be able to provide signed informed consent, meaning you understand and agree to the study’s requirements and restrictions.
If participating in the United States, must have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, similar authorization may be required according to national laws.
Women who can become pregnant or men who are sexually active with partners who can become pregnant must agree to use highly effective birth control methods before starting the study, during the study, and for at least 4 months after the last treatment. The birth control methods should comply with local regulations for clinical studies.
Who Cannot Join the Study?
Patients with any other eye disease that could affect vision.
Patients who have had eye surgery in the last 3 months.
Patients with an eye infection.
Patients who are allergic to the study medication or any of its ingredients.
Patients who are pregnant or breastfeeding.
Patients with uncontrolled high blood pressure.
Patients with a history of stroke or heart attack in the last 6 months.
Patients who are participating in another clinical trial.
Patients with a serious illness that could affect their ability to participate in the study.
Aflibercept is a medication used in this clinical trial to treat macular edema, which is a condition where fluid builds up in the macula, the part of the eye responsible for sharp vision. This medication works by blocking a protein that causes abnormal blood vessels to grow and leak fluid. By doing so, it helps reduce swelling and improve vision. In this study, the effectiveness and safety of aflibercept are being tested to see if it can help maintain or improve vision in patients with macular edema due to retinal vein occlusion.
Macular edema secondary to retinal vein occlusion – This condition occurs when fluid accumulates in the macula, the central part of the retina, due to a blockage in the retinal veins. The blockage leads to increased pressure and leakage of fluid from blood vessels, causing swelling. As the macula swells, it can distort vision, making it blurry or wavy. Over time, the persistent fluid can damage the macula, affecting central vision. The progression of this condition can vary, with some individuals experiencing gradual changes, while others may notice more rapid alterations in their vision. Regular monitoring is essential to understand the changes in vision and the extent of macular swelling.
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