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

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What is this study about?

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.

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.

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).

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.

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 Study?

  • 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.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
F D Roosevelt University General Hospital Of Banska Bystrica Banska Bystrica Slovakia
University Hospital Bratislava Bratislava Slovakia
Santa Sp. z o.o. Lodz Poland
Warszawski Szpital Okulistyczny Sp. z o.o. Warsaw Poland
MBAL Trakia EOOD Stara Zagora Bulgaria
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o. Olsztyn Poland
Specialized Eye Hospital For Active Treatment Pentagram ЕООD Sofia Bulgaria
Multiprofile Hospital For Active Treatment Dr. Bratan Shukerov AD Smolyan Bulgaria
Opca Bolnica Zadar Zadar Croatia
Clinical Medical Center Osijek Osijek Croatia
Specialized Eye Diseases Hospital For Active Treatment-Varna EOOD Varna Bulgaria
Specialized Hospital for Active Treatment of Oncology Diseases Prof. d-r Marin Mushmov EOOD Sofia Bulgaria
Multidisciplinary Hospital For Active Treatment Haskovo AD Haskovo Bulgaria
Fakultna Nemocnica S Poliklinikou Zilina Zilina Slovakia
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD Sofia Bulgaria
Cysv Ceuohqi Ogqnfzuutw Swa z omgu Cracow Poland
Ohvvftr Czufnmvrq Ojk Ptexuuebeccyxclefz Soi z osag Naleczow Poland
Rvjmpj Opfhusovvk Suf z oejq Warsaw Poland
Pdqopskktx Cbxyfjh Wspufz Mnosu Msnlcl Maqawqb Mezmvs Sbc jf Poznan Poland
Ctqftva Mrcydgfq Dgnpdt 1r Syt z owhf Cracow Poland
Prxbigib Buuzrns Kdylxjmaa Scu z owoe Czestochowa Poland
Ojuuixeavdu Sap z ohke Bydgoszcz Poland
Ozwmvpq Codbhyxjq Ovd Pcybd Zpgvvoezffu W Nvhqg Swbni Slj z oqxx Nowy Sacz Poland
Mnzfiry Cwlqqg Fta Sbzrrbjztsy Mfjmedy Aya Vespa Ood Gorna Oryahovitsa Bulgaria
Mqtuvlakqm Cizpda Pr Ovdte Buwkcgp Del Mhuyiwnh Oeb Shumen Bulgaria
Hqrjou Ccdz 3 Mrtgfme Cofomp Lpmp Sofia Bulgaria
Uddymyccnz Heztrtnm Lweaxtlc Sofia Bulgaria
Phpdthudesfa Cyureua Msqesngg Svp z opul Gdansk Poland
Cooluwjly Sga z owxu Tarnowskie Gory Poland
Kdseivaz bqpocfiq cmfaux Rkautl (wkphjzwx Hipeehbo Cidutg Rjmqpja Rijeka Croatia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
10.05.2024
Croatia Croatia
Not recruiting
10.05.2024
Poland Poland
Not recruiting
10.05.2024
Slovakia Slovakia
Not recruiting
10.05.2024

Trial locations

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.

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.

Trial ID:
2023-509206-29-00
Protocol code:
PD-CP-Y1
Trial Phase:
Therapeutic confirmatory (Phase III)

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