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Study Comparing RBS-001 and Aflibercept for Patients with Neovascular Age-Related Macular Degeneration

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called neovascular age-related macular degeneration (nAMD), which affects the eyes and can lead to vision loss. The study will compare two treatments: RBS-001 and Eylea. Both treatments involve a medication called aflibercept, which is used to help manage this eye condition. Aflibercept works by blocking a protein that can cause abnormal blood vessel growth in the eye, which is a key problem in nAMD.

The purpose of the study is to see if RBS-001 is as effective and safe as Eylea in treating nAMD. Participants in the study will receive injections of either RBS-001 or Eylea directly into the eye, a method known as intravitreal use. The study will also use a substance called fluorescein sodium to help doctors see the blood vessels in the eye more clearly during certain tests. This is done through a process called fluorescence angiography, which involves injecting fluorescein sodium into a vein to highlight the blood vessels in the eye.

Throughout the study, participants will have their vision tested regularly to monitor changes. The main focus will be on the change in vision clarity, measured by a test called the ETDRS letter score, at different points in time, especially at 8 weeks after starting treatment. The study will last for up to 52 weeks, with regular check-ups to ensure the safety and effectiveness of the treatments. The goal is to determine if RBS-001 can provide similar benefits to Eylea for people with nAMD.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment
The clinical trial begins with the administration of the first dose of the investigational product. This involves an injection of aflibercept into the eye, known as intravitreal use. The product used is Eylea 40 mg/mL solution for injection.
The purpose of this initial treatment is to assess the baseline visual acuity using the ETDRS letter score, which is a standardized method to measure vision.
Step 2
Follow-up assessments
After the initial treatment, follow-up assessments are conducted at various intervals to monitor changes in visual acuity. These assessments occur at weeks 4, 8, 12, 16, 20, and 24.
During these visits, the change in visual acuity from the baseline is measured using the ETDRS letter score. The presence of fluid in the retina is also checked using optical coherence tomography (OCT).
Step 3
Secondary evaluations
Secondary evaluations include measuring the proportion of participants whose visual acuity changes by specific amounts (5, 10, or 15 letters) from the baseline at each visit.
The area of choroidal neovascularization (CNV) is assessed using fluorescein angiography (FA) at 24 and 52 weeks to determine any changes from the screening period.
Step 4
Final assessment
The final assessment occurs at 52 weeks after the initial treatment. This includes a comprehensive evaluation of visual acuity, retinal fluid presence, and CNV area.
The results from this assessment help determine the overall effectiveness and safety of the investigational product compared to the standard treatment.

Who can join the trial?

6 criteria

Must be **50 years or older** at the time of screening.
Must have an **active CNV lesion** in the study eye due to age-related macular degeneration, confirmed by a special eye test called **fluorescein angiography** (FA) during the screening period.
The **CNV area** in the study eye should make up **50% or more** of the total affected area, including any bleeding, scarring, or new blood vessel growth, confirmed by FA during the screening period.
Must have **fluid in the retina** of the study eye due to active CNV, confirmed by a special scan called **optical coherence tomography** (OCT) during the screening period.
Must have a **BCVA** (Best Corrected Visual Acuity) score between **34 to 73 letters** on a special eye chart called the **ETDRS letter score** at both the screening and baseline visits in the study eye.
Must voluntarily agree to participate in the study after being fully informed about it and provide **written consent** to follow the study instructions.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Clinical Medical Center Osijek
Osijek, Croatia
Verified
Klinički bolnički centar Rijeka (Clinical Hospital Center Rijeka)
Rijeka, Croatia
Verified
Profesorskie Centrum Medyczne Sp. z o.o.
Gdansk, Poland

Trial locations

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Investigated drugs

RBS-001
is an investigational medication being studied for its effectiveness in treating neovascular age-related macular degeneration. This medication is being compared to an existing treatment to see if it can provide similar benefits in improving vision.
Eylea
is a medication already used to treat neovascular age-related macular degeneration. It works by blocking a protein that can cause abnormal blood vessels to grow in the eye, which can lead to vision loss. The trial aims to compare Eylea with RBS-001 to evaluate their effectiveness and safety.

What is already known about the treatment

Eylea
Eylea is administered as an injection directly into the eye, specifically targeting the treatment of neovascular age-related macular degeneration (nAMD). It is well-established in medical literature and widely used in clinical practice for this condition. The medication works by inhibiting the activity of vascular endothelial growth factor (VEGF), which plays a key role in the formation of abnormal blood vessels in the eye. Eylea is classified as an anti-VEGF agent, helping to prevent vision loss in patients with nAMD.
RBS-001
RBS-001 is administered as an injection into the eye, similar to Eylea, and is currently being evaluated in clinical trials for its effectiveness in treating neovascular age-related macular degeneration (nAMD). The medication aims to demonstrate equivalence to Eylea in terms of improving visual acuity. It functions by blocking the action of vascular endothelial growth factor (VEGF), thereby reducing the growth of abnormal blood vessels in the eye. RBS-001 is classified as an anti-VEGF agent, and its development is focused on providing an alternative treatment option for nAMD.

Investigated diseases

Neovascular Age-Related Macular Degeneration (nAMD) – This is a chronic eye condition that affects the macula, the central part of the retina responsible for sharp vision. It occurs when abnormal blood vessels grow under the retina and macula, leading to leakage of blood and fluid. This leakage can cause the macula to lift or bulge, distorting or destroying central vision. The disease typically progresses with a gradual loss of central vision, which can affect activities like reading and recognizing faces. Peripheral vision usually remains unaffected, allowing individuals to maintain some level of independence. The progression can vary, with some experiencing rapid changes in vision.