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Vascular Endothelial Growth Factor Receptor 3 Extracellular Domains 1-3 Fused To A Igg1 Fc Fragment

Clinical trials are currently underway to assess the effectiveness of a new drug called OPT-302 in treating wet age-related macular degeneration (AMD). This drug, which contains Vascular Endothelial Growth Factor Receptor 3 Extracellular Domains 1-3 Fused To A IgG1 Fc Fragment, is being tested in combination with existing treatments like ranibizumab and aflibercept. These studies aim to determine if OPT-302 can improve vision and reduce symptoms in patients with this serious eye condition.

Table of Contents

What is OPT-302?

OPT-302 is a new medication being studied for the treatment of wet age-related macular degeneration (wet AMD), a serious eye condition that can lead to vision loss. It is also known as VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTOR 3 EXTRACELLULAR DOMAINS 1-3 FUSED TO A IGG1 FC FRAGMENT.[1] [2]

This medication is classified as a biological or biotechnological product, which means it is created using living organisms or their products. OPT-302 is not considered an advanced therapy medicinal product (ATIMP).[1] [2]

Medical Condition: Wet Age-Related Macular Degeneration

Wet age-related macular degeneration (wet AMD) is a chronic eye disease that affects the macula, the central part of the retina responsible for sharp, detailed vision. In wet AMD, abnormal blood vessels grow under the retina and leak fluid, causing damage to the macula and potentially leading to vision loss.[1] [2]

How OPT-302 Works

OPT-302 is designed to target specific proteins called vascular endothelial growth factors (VEGFs). These proteins are responsible for the growth of abnormal blood vessels in wet AMD. By blocking these proteins, OPT-302 aims to prevent the formation of new blood vessels and reduce leakage from existing ones, potentially slowing down or stopping the progression of the disease.[1] [2]

Clinical Trials

OPT-302 is currently being studied in two Phase 3 clinical trials:

  1. A study comparing OPT-302 in combination with ranibizumab to ranibizumab alone.[1]

  2. A study comparing OPT-302 in combination with aflibercept to aflibercept alone.[2]

Both studies aim to determine the effectiveness and safety of OPT-302 when used in combination with existing treatments for wet AMD. The main goal is to see if adding OPT-302 to current treatments can improve vision outcomes for patients.[1] [2]

Eligibility Criteria

To participate in these clinical trials, patients must meet certain criteria, including:

  • Being at least 50 years old
  • Having active wet AMD in the study eye
  • Having a specific level of visual acuity (measured using the Early Treatment Diabetic Retinopathy Study [ETDRS] scale)
  • Not having received any previous treatment for wet AMD in the study eye

It’s important to note that these are just some of the criteria, and a healthcare professional would need to assess each individual case.[1] [2]

Potential Benefits

The clinical trials are designed to measure several potential benefits of OPT-302, including:

  • Improvement in visual acuity (the ability to see clearly)
  • Reduction in the size of abnormal blood vessel growth
  • Decrease in fluid accumulation in the retina

These outcomes are measured using various tests, including visual acuity tests, fluorescein angiography (a special photograph of the eye’s blood vessels), and optical coherence tomography (a non-invasive imaging test that provides detailed images of the retina).[1] [2]

Administration

OPT-302 is administered as an intravitreal injection, which means it is injected directly into the eye. The dose being studied is 2.0 mg. In the clinical trials, patients receive multiple injections over a period of 52 weeks (about one year).[1] [2]

Aspect Details
Drug Name OPT-302
Active Substance Vascular Endothelial Growth Factor Receptor 3 Extracellular Domains 1-3 Fused To A IgG1 Fc Fragment
Condition Treated Neovascular Age-related Macular Degeneration (wet AMD)
Administration Method Intravitreal injection
Dosage 2.0 mg
Combination Treatments Ranibizumab (0.5 mg) or Aflibercept (2.0 mg)
Primary Endpoint Change in ETDRS BCVA letters from baseline to Week 52
Key Secondary Endpoints Proportion of participants gaining 15 or more ETDRS BCVA letters, changes in CNV area, absence of SRF and IR cysts
Study Duration 52 weeks (primary phase), up to 96 weeks total
Eligibility Age 50 years and older

FAQ

  • What is OPT-302 and how does it work? OPT-302 is a new drug being tested for wet age-related macular degeneration. It works by targeting specific growth factors in the eye that contribute to the disease. The drug is designed to be used in combination with other treatments to potentially improve vision outcomes.
  • Who is eligible to participate in these clinical trials? The trials are open to men and women aged 50 and older who have active wet AMD in one eye. Participants must have a certain level of visual acuity as measured by a standard eye test. People who have had previous treatment for wet AMD in the study eye are not eligible.
  • How is OPT-302 administered in these trials? OPT-302 is given as an intravitreal injection, which means it is injected directly into the eye. In the trials, it is administered in combination with either ranibizumab or aflibercept, which are existing treatments for wet AMD.
  • What are the main goals of these clinical trials? The primary goal is to determine if adding OPT-302 to current treatments improves vision more than the current treatments alone. Researchers will measure changes in visual acuity over 52 weeks. They will also assess safety and look at changes in the structure of the eye using various imaging techniques.
  • How long do the clinical trials last? The main phase of the trials lasts for 52 weeks (1 year). During this time, participants will receive regular eye examinations and treatments. Some participants may continue in the study for up to 96 weeks to gather more long-term data on the effectiveness and safety of OPT-302.

Ongoing Clinical Trials on Vascular Endothelial Growth Factor Receptor 3 Extracellular Domains 1-3 Fused To A Igg1 Fc Fragment

  • Study of OPT-302 and Aflibercept for Patients with Wet Age-related Macular Degeneration

    Not recruiting

    1 1 1
    Investigated drugs:
    Austria Bulgaria Croatia Czechia Estonia France +10

  • Study on the Effectiveness of OPT-302 and Ranibizumab for Patients with Wet Age-related Macular Degeneration

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Czechia Denmark France Germany Greece Hungary +4

Glossary

  • Neovascular Age-related Macular Degeneration (wet AMD): A serious eye condition where abnormal blood vessels grow under the retina, leading to vision loss. It's called 'wet' because these vessels can leak fluid and blood into the eye.
  • Intravitreal: Refers to the space within the eye. In these trials, 'intravitreal injection' means the medication is injected directly into the eye.
  • ETDRS BCVA: Stands for 'Early Treatment Diabetic Retinopathy Study Best Corrected Visual Acuity'. It's a standardized way to measure how well a person can see at different distances.
  • Subfoveal CNV lesion: Choroidal neovascularization (new blood vessel growth) occurring directly under the fovea, the central part of the retina responsible for sharp, detailed vision.
  • Fluorescein Angiography (FA): An eye test that uses a special dye and camera to look at blood flow in the retina and choroid, the back layers of the eye.
  • Spectral Domain Optical Coherence Tomography (SD-OCT): A non-invasive imaging test that uses light waves to take detailed cross-section pictures of the retina.
  • SRF: Stands for Subretinal Fluid, which is fluid that accumulates under the retina and can distort vision.
  • IR cysts: Intraretinal cysts, which are fluid-filled spaces within the layers of the retina that can affect vision.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-opt-302-and-ranibizumab-for-patients-with-wet-age-related-macular-degeneration/
  2. http://clinicaltrials.eu/trial/study-of-opt-302-and-aflibercept-for-patients-with-wet-age-related-macular-degeneration/