Testing the effectiveness of new drugs in the treatment of age-related macular degeneration

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    What is this study about?

    The study is investigating a potential breakthrough in treating age-related vision loss, specifically neovascular age-related macular degeneration (nAMD). It introduces a novel therapy, OPT-302, and pairs it with Aflibercept, comparing this combination’s effectiveness against the standard treatment. Participants undergo a series of thorough eye examinations and treatments to monitor the progression of their vision health. The research aims to offer a clearer understanding of how these treatments can better manage and possibly improve vision for individuals dealing with nAMD, contributing valuable knowledge to the field of eye health care.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Graz , Austria

      Sofia , Bulgaria

      Stara Zagora , Bulgaria

      Hradec Kru00e1lovu00e9 , Czechia

      Brno , Czechia

      Praha 2 , Czechia

      Praha 4-Krc , Czechia

      Praha , Czechia

      Praha , Czechia

      Roskilde , Denmark

      Dijon , France

      Lyon , France

      Poitiers , France

      Paris , France

      Tuebingen , Germany

      Koeln , Germany

      Mainz , Germany

      Berlin , Germany

      Athens , Greece

      Heraklion , Greece

      Larissa , Greece

      Thessalonu00edki , Greece

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Budapest , Hungary

      Debrecen , Hungary

      Nyiregyhaza , Hungary

      Pu00e9cs , Hungary

      Pu00e9cs , Hungary

      Zalaegerszeg , Hungary

      Ancona , Italy

      Firenze , Italy

      Milano , Italy

      Milano , Italy

      Milan , Italy

      Pisa , Italy

      Roma , Italy

      Rome , Italy

      Rozzano , Italy

      Nijmegen , Netherlands

      Rotterdam , Netherlands

      Tilburg , Netherlands

      Bielsko-Biala , Poland

      Bydgoszcz , Poland

      Bydgoszcz , Poland

      Bytom , Poland

      Lublin , Poland

      Olsztyn , Poland

      Poznau0144 , Poland

      u0141u00f3du017a , Poland

      Bratislava , Slovakia

      Trebiu0161ov , Slovakia

      Trenu010du00edn , Slovakia

      u017dilina , Slovakia

      Oviedo , Spain

      Badalona , Spain

      Majadahonda , Spain

      Barcelona , Spain

      Barcelona , Spain

      Barcelona , Spain

      Madrid , Spain

      Valencia , Spain

      Zaragoza , Spain

      Zaragoza , Spain

      Plymouth , United Kingdom

      Westcliff-on-Sea , United Kingdom

      Manchester , United Kingdom

      Liverpool , United Kingdom

      Gorleston-on-Sea , United Kingdom

      Frimley , United Kingdom

      Sunderland , United Kingdom

      Leeds , United Kingdom

      London , United Kingdom

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The clinical trial involves several steps for patients, depending on which group they are assigned to:

      1. For patients in the “2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302” group, there are two medications involved:
      – They will receive a 2.0 mg aflibercept intravitreal injection at 4-weekly intervals for the first three treatments, and then at 8-weekly intervals.
      – Alongside, they will receive a 2.0 mg OPT-302 intravitreal injection at 4-weekly intervals.

      2. For patients in the “2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302” group, the regimen is similar to the first group with a slight variation:
      – They will receive a 2.0 mg aflibercept intravitreal injection at 4-weekly intervals for three treatments, and then at 8-weekly intervals.
      – They will also receive a 2.0 mg OPT-302 intravitreal injection at the same schedule as aflibercept for the first three treatments, and then at 8-weekly intervals with sham intravitreal injections administered at the visits when OPT-302 is not given.

      3. In the “2.0 mg aflibercept with sham” group, which is the sham comparator group, patients will receive:
      – A 2.0 mg aflibercept intravitreal injection at 4-weekly intervals for three treatments, and then at 8-weekly intervals.
      – They will receive sham intravitreal injections at 4-weekly intervals.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have an active subfoveal or juxtafoveal choroidal neovascularization (CNV) lesion with foveal involvement that is secondary to age-related macular degeneration (AMD) in the study eye .


      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Inclusion Criteria:

      • Active subfoveal or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
        • CNV refers to choroidal neovascularization, which is the formation of new blood vessels in the choroid layer beneath the retina.
        • Subfoveal means that the lesion is located directly under the center of the macula.
        • Juxtafoveal means the lesion is near or adjacent to the fovea but not directly under its center.
        • Foveal involvement indicates that the fovea, the small central pit in the eye responsible for sharp vision, is affected by the lesion.
        • AMD stands for Age-related Macular Degeneration, a common eye condition leading to vision loss among people over the age of 50.
      • An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.
        • ETDRS BCVA refers to Early Treatment Diabetic Retinopathy Study Best Corrected Visual Acuity. It is a standard chart test used to measure how well a person sees at a distance after their vision has been corrected with glasses or contact lenses.
        • A score between 60 and 25 letters indicates a range of visual acuity from moderate visual impairment to severe visual impairment.

      What Reasons Could Exclude Me from the Study?

      Main Exclusion Criteria:

      1. Any previous treatment for neovascular Age-related Macular Degeneration (AMD): Participation in the study is prohibited if you have previously received treatment specifically for the wet form of AMD, which is the disease being studied.
      2. Clinically significant ocular disorders other than neovascular AMD: If you have eye disorders that could affect the assessment of your best corrected visual acuity (BCVA), safety evaluations, or imaging of the fundus (the interior surface of the eye), you are not eligible. This helps ensure that study results are due to the treatment being tested rather than another eye condition.
      3. Any current or past social, psychological, or medical condition that would prevent participation in the study: If you have any conditions that would make it difficult for you to adhere to study procedures or requirements, you may be excluded for your own safety and to ensure the integrity of the study data .

      Note: Please let me know if you need further assistance or explanations of specific medical terms.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in this study are:

      1. OPT-302: An investigational drug being tested for the treatment of neovascular age-related macular degeneration (nAMD). Its role in the study is to evaluate its efficacy and safety when used in combination with aflibercept, compared to aflibercept alone.
      2. Aflibercept (Eylea): An anti-VEGF drug used to treat nAMD by inhibiting the growth of abnormal blood vessels in the eye. In this study, aflibercept serves as the standard treatment, and its efficacy is being compared when used alone or in combination with OPT-302.

      Both drugs are administered via intravitreal injection (injection into the eye) at specific intervals throughout the study period. The study aims to determine if the combination of OPT-302 and aflibercept provides better outcomes for patients with nAMD compared to aflibercept alone.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The clinical trial involves two active substances known to medicine and the medical literature:

      • 2.0 mg OPT-302: OPT-302 is described as a biological intervention administered as an intravitreal injection. While the document does not provide a detailed profile of OPT-302 within the scope of existing medical literature, it is utilized at 4-weekly intervals for the first three treatments and then at 8-weekly intervals in the context of this trial.
      • 2.0 mg Aflibercept: Aflibercept is another substance used in this trial and is also administered as an intravitreal injection at similar intervals as OPT-302. Aflibercept is a well-known medication within medical literature and is classified under various categories, including angiogenesis inhibitors, which are substances that inhibit the growth of new blood vessels, an essential process for tumor growth and metastasis. It’s often used for eye diseases related to vascular issues, such as macular degeneration.

      Study ID

      CT-EU-00054212

      Recruitment status

      Recruting new patients

      Start of the trial

      3 years ago

      Study phase

      Phase
      III

      Medicinal Product