Retinal neovascularisation Trials in Disease

Study Comparing Bevacizumab and Aflibercept for Patients with Wet Age-related Macular Degeneration

This clinical trial is examining treatments for neovascular age-related macular degeneration, commonly known as wet AMD. This is an eye condition that primarily affects older adults and can lead to significant vision loss. The condition occurs when abnormal, fragile blood vessels grow beneath the retina and leak blood and fluid, damaging the macula, which is the central part of the retina responsible for detailed, sharp vision.

Main focus: The study aims to compare two anti-VEGF medications, bevacizumab and aflibercept, to determine which treatment requires fewer injections over a two-year period while maintaining effective vision preservation. Both medications work by blocking a protein called VEGF that promotes the growth of abnormal blood vessels in the eye. The trial will monitor various outcomes including visual clarity, the thickness of the macula, eye pressure, treatment intervals, and the overall cost-effectiveness of each approach.

Investigational drugs:

• Bevacizumab (brand name Avastin) is administered as an intravitreal injection directly into the eye. It blocks the VEGF protein to prevent the growth of harmful blood vessels and helps slow vision loss.
• Aflibercept (brand name Eylea) is also given as an intravitreal injection. It works by trapping the VEGF protein, preventing it from causing blood vessel growth in the eye and helping to maintain vision.

Inclusion criteria: To participate in this trial, you must meet the following requirements:

• Be at least 50 years old
• Have a confirmed diagnosis of neovascular (wet) age-related macular degeneration, verified through specialized eye scans such as OCT-A and possibly FA/ICG
• Have distance visual acuity of at least 34 on the ETDRS scale in the eye being studied
• Provide signed informed consent agreeing to participate in the study

Exclusion criteria: You cannot participate in this trial if you have:

• Other eye diseases that could interfere with the study results
• Had eye surgery within the past three months
• Are currently enrolled in another clinical trial
• Have allergies to the study medications
• Are pregnant or breastfeeding
• Have uncontrolled high blood pressure
• Have experienced a stroke or heart attack in the last six months
• Have severe kidney or liver disease
• Have any condition that the study doctor considers would make participation unsafe

What to expect during the trial: After joining the study and providing informed consent, you will undergo an initial assessment to confirm your eligibility. This includes eye examinations and diagnostic tests to evaluate your condition. You will then be randomly assigned to receive either bevacizumab or aflibercept through intravitreal injections. This is a double-blind study, meaning neither you nor the study staff will know which medication you are receiving. Throughout the two-year study period, you will attend regular follow-up visits to monitor your vision, macular thickness, and eye pressure. At the end of the study, a final evaluation will assess how many injections you received and the overall effectiveness of your treatment.