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Ongoing Clinical Trials for Macular Oedema

This article provides information about 5 ongoing clinical trials investigating new treatments for macular oedema, a condition characterized by fluid accumulation in the central part of the retina. These studies are testing various medications and treatment approaches, including intravitreal injections and laser therapies, across multiple countries in Europe.

Clinical trial locations

Study on the Effects of RO7200220 for Patients with Uveitic Macular Edema

This trial is testing a new medication called RO7200220 for patients with uveitic macular edema, a condition where swelling occurs in the central part of the retina due to eye inflammation. The medication is a humanised monoclonal antibody that targets interleukin-6, a protein involved in inflammation.

Main inclusion criteria: Participants must have a confirmed diagnosis of macular edema associated with non-infectious uveitis, verified through a special eye scan called spectral-domain optical coherence tomography. They must have vision that falls between 20/40 and 20/400 on a standard eye chart. The trial is open to both males and females, including vulnerable populations.

Main exclusion criteria: People with other eye diseases that could affect vision, those who have had recent eye surgery in the last three months, or those currently using certain medications that could interfere with the study results are excluded. Pregnant or breastfeeding women, people with uncontrolled high blood pressure, and those with a history of severe allergic reactions cannot participate.

Focus and goal: The study aims to evaluate how effective and safe RO7200220 is in improving vision and reducing retinal swelling. The medication is injected directly into the eye through a method called intravitreal administration. Researchers will monitor changes in vision and eye health at specific time points, including weeks 16, 20, and 52, tracking improvements in visual clarity and reductions in retinal thickness.

Investigational drug: RO7200220 is administered as an injection directly into the eye. By targeting inflammation pathways, it aims to reduce fluid buildup in the retina and improve vision. The trial is designed to assess both the effectiveness of this medication and monitor any potential side effects.

Study on the Use of SB11 Pre-Filled Syringe for Patients with Wet Age-Related Macular Degeneration, Macular Edema from Retinal Vein Occlusion, or Myopic Choroidal Neovascularization

This trial focuses on evaluating the usability of a pre-filled syringe containing Byooviz, which contains the active substance ranibizumab, for treating various eye conditions including macular edema secondary to retinal vein occlusion. The study assesses how well healthcare professionals can prepare and administer this treatment directly into the eye.

Main inclusion criteria: Participants must be at least 18 years old and have one of the following conditions in their study eye: macular edema due to retinal vein occlusion, neovascular age-related macular degeneration, or myopic choroidal neovascularization. The eye must be suitable for treatment with ranibizumab as determined by a specialist. Both male and female participants who can have children must agree to use effective birth control methods.

Main exclusion criteria: People with other eye diseases that could affect results, those who have had recent eye surgery, or those currently receiving other eye treatments within the last three months cannot participate. People with severe allergies to study medications, uncontrolled high blood pressure, serious health conditions, pregnant or breastfeeding women, and those participating in other trials are excluded.

Focus and goal: The main goal is to evaluate how effectively healthcare professionals can follow instructions to prepare and administer the injection using a pre-filled syringe. Participants receive a single dose and are monitored for any side effects or vision changes over approximately one week. The study emphasizes both the ease of use of the pre-filled syringe and the safety of the treatment.

Investigational drug: SB11, delivered through a pre-filled syringe, is an anti-VEGF medication that inhibits abnormal blood vessel growth in the eye. It is administered as an intravitreal injection to reduce swelling and improve vision in people with these eye conditions.

Study on Ranibizumab Injections and Laser Treatment for Macular Edema in Central Retinal Vein Occlusion Patients

This trial investigates treatment for macular edema caused by central retinal vein occlusion, where the main vein in the retina becomes blocked, affecting blood flow and causing swelling. The study combines ranibizumab injections with an early laser procedure to see if this reduces the need for ongoing injections.

Main inclusion criteria: Participants must have macular edema due to central retinal vein occlusion with retinal thickness greater than 250 micrometers. They must be at least 18 years old and have vision between 20/320 and 20/25 on a special eye chart. The blockage must have occurred within the last six months, and there must be evidence of reduced blood flow in specific areas of the retina. Participants must be willing to attend all scheduled visits.

Main exclusion criteria: People without macular edema caused by central retinal vein occlusion, those outside the specified age range, and vulnerable populations that may require special protection are excluded from participation.

Focus and goal: The study aims to determine if combining ranibizumab injections with targeted peripheral laser photocoagulation can reduce the frequency of injections needed. Participants receive three initial monthly injections, followed by additional treatments as needed based on specific criteria. The goal is to achieve at least six months without requiring further injections, indicating treatment success.

Investigational drugs: Ranibizumab is an anti-VEGF medication that blocks proteins causing abnormal blood vessel growth and fluid leakage. Targeted peripheral laser photocoagulation is used alongside ranibizumab to stabilize the retina and potentially reduce the need for frequent injections, improving long-term outcomes.

Study on the Effectiveness and Safety of Aflibercept for Patients with Vision Loss Due to Macular Edema from Retinal Vein Blockage

This trial studies aflibercept, a protein-based treatment given as an eye injection for macular edema caused by retinal vein occlusion. The study compares two different dosing schedules to determine which is more effective: 8 mg every 8 weeks versus 2 mg every 4 weeks.

Main inclusion criteria: Participants must be adults aged 18 or older with new, untreated macular edema caused by branch, hemiretinal, or central retinal vein occlusion diagnosed within the last 16 weeks. Vision must fall between 20/40 and 20/320 on a standard eye chart, and the vision decrease must be mainly due to the vein blockage. Retinal thickness measured by optical coherence tomography must meet specific criteria. Participants must provide informed consent and, if applicable, use effective birth control during and after the study.

Main exclusion criteria: People with other eye diseases affecting vision, recent eye surgery within three months, eye infections, allergies to the study medication, pregnant or breastfeeding women, those with uncontrolled high blood pressure, recent stroke or heart attack within six months, participation in other trials, or serious illnesses that could affect study participation are excluded.

Focus and goal: The study aims to determine if the higher dose given less frequently is as effective as the lower dose given more frequently. Participants have their vision tested regularly using a special chart that measures how well they can see letters. The study also tracks the number of injections needed and monitors any side effects over approximately 64 weeks.

Investigational drug: Aflibercept is an anti-VEGF medication that blocks proteins promoting abnormal blood vessel growth and fluid leakage. By reducing swelling in the macula, it helps improve vision in patients with macular edema due to retinal vein occlusion.

Study on the Effects of RO7200220 for Adults and Children with Uveitic Macular Edema

This trial tests RO7200220, also known as IL6-Mab, for treating uveitic macular edema in both adults and children. The medication is a humanised monoclonal antibody designed to target and reduce inflammation in the eye.

Main inclusion criteria: Participants must have macular edema associated with non-infectious uveitis, confirmed by spectral-domain optical coherence tomography. They must have active or inactive, acute or chronic inflammation of any cause affecting any part of the eye. Vision must be between 20/40 and 20/400 on a standard eye chart. The trial is open to both males and females of various age groups.

Main exclusion criteria: People with other eye diseases that could affect vision, recent eye surgery within three months, current treatment for uveitic macular edema with other medications, history of severe allergic reactions, pregnant or breastfeeding women, uncontrolled high blood pressure, recent history of drug or alcohol abuse, participation in another trial within the last 30 days, or any condition the study doctors believe would make participation unsafe are excluded.

Focus and goal: The study evaluates how effective and safe RO7200220 is in improving vision and reducing retinal swelling over up to 52 weeks. Participants receive the medication through intravenous injection and have regular follow-up visits to monitor vision and eye condition. The primary goal is to evaluate improvement in vision, specifically looking for a 15-letter improvement from baseline at week 16.

Investigational drug: RO7200220 is administered as an injection and targets specific inflammatory pathways to reduce fluid buildup in the retina. The trial monitors both effectiveness in improving vision and safety by tracking any side effects throughout the treatment period.

Summary

These five ongoing clinical trials represent current research efforts to find effective treatments for various types of macular oedema. The trials span multiple European countries, with the largest trial testing aflibercept being conducted across 14 countries, demonstrating the international scope of research in this field.

A notable pattern is that several trials focus on uveitic macular edema, with two studies testing the same medication, RO7200220, in different patient populations. Three trials focus on conditions related to retinal vein occlusion, testing different medications including ranibizumab and aflibercept. The trials employ various treatment approaches, with most using intravitreal injections but differing in dosing schedules and whether they combine medication with other therapies like laser treatment.

Germany, Italy, Portugal, and Austria appear most frequently as trial locations, suggesting these countries have established centres of excellence for retinal disease research. The variety of medications being tested, all targeting similar mechanisms related to abnormal blood vessel growth and inflammation, reflects the ongoing scientific exploration of the best approaches to manage this vision-threatening condition.

Ongoing Clinical Trials on Macular oedema

  • Study on the Use of SB11 Pre-Filled Syringe for Patients with Wet Age-Related Macular Degeneration, Macular Edema from Retinal Vein Occlusion, or Myopic Choroidal Neovascularization

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

  • Study on EYE103 and Ranibizumab for Patients with Diabetic Macular Edema

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Croatia Czechia France Germany Hungary +6

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