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Diabetic retinal oedema – Trials in Disease

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Clinical Trials for Diabetic Retinal Oedema

There are currently 10 ongoing clinical trials investigating treatments for diabetic retinal oedema. These studies are testing various medications including eye drops, oral tablets, and injections, with trials taking place across multiple European countries including Germany, France, Spain, Poland, Hungary, and others.

Clinical trial locations

Study Comparing Fluocinolone Acetonide and Dexamethasone Implants for Patients with Resistant Diabetic Macular Edema

This French trial compares two types of eye implants for patients whose condition has not responded well to previous treatments. The study focuses on comparing the ILUVIEN implant (fluocinolone acetonide) with the OZURDEX implant (dexamethasone) over a three-year period.

Who can participate: Adults aged 18 or older who have retinal swelling with a central thickness greater than 300 microns despite at least two years of previous treatment. Participants must have had cataract surgery more than six months ago and must have experienced good results from a dexamethasone injection lasting more than five months. They should also have received anti-VEGF treatment for more than three months.

Who cannot participate: Patients without confirmed diagnosis, those who have not had cataract surgery, those whose condition has improved with other treatments, and those outside the specified age range.

Main focus: The trial evaluates the cost-effectiveness of these two implant treatments over three years, measuring improvements in vision and quality of life while monitoring any side effects.

Investigational drugs: Both implants are small devices placed inside the eye to release medication slowly, reducing inflammation and swelling to improve vision.

Study of Faricimab treatment to improve vision in patients with diabetic macular edema using adaptive optics imaging

This German study investigates faricimab (marketed as Vabysmo), delivered through eye injections, to assess how well it improves vision over 12 months. The medication targets specific proteins that contribute to abnormal blood vessel growth in the eye.

Who can participate: Adults aged 18 or older with HbA1c levels of 16% or less, whose vision in the study eye is better than 25 letters on a specialized eye chart.

Who cannot participate: People with active eye infections or inflammation, those who have had recent eye surgery, pregnant women, individuals with uncontrolled blood pressure, and those who have experienced a stroke or heart attack within the past three months.

Main focus: The study measures vision improvements using standardized eye tests and examines changes in blood vessels using advanced imaging techniques. Treatment frequency varies from every 4 to 16 weeks depending on individual response.

Investigational drug: Faricimab is a bispecific antibody that simultaneously blocks two pathways involved in blood vessel growth and inflammation, making it unique among eye medications.

Study on the Effectiveness and Safety of EYE103 Compared to Ranibizumab for Patients with Diabetic Macular Edema

This large international trial across 12 European countries compares the new treatment EYE103 with the established medication ranibizumab. Both are given as eye injections over 52 weeks to evaluate whether EYE103 can provide similar vision improvements.

Who can participate: Adults aged 18 or older who can provide informed consent and follow study procedures. Female participants of childbearing potential must use effective contraception during the study and for three months afterward. Male participants must also agree to contraception during the study and for 90 days after the last dose.

Who cannot participate: The trial excludes individuals who do not have confirmed diagnosis, those outside the age range, and members of vulnerable populations requiring special protection.

Main focus: The trial assesses changes in vision using the ETDRS eye chart at various time points throughout the year-long study period. Researchers will monitor safety and effectiveness to determine if EYE103 performs as well as ranibizumab.

Investigational drugs: EYE103 is a new medication being tested, while ranibizumab is an existing treatment that blocks proteins causing abnormal blood vessel growth and leakage in the eye.

Study of oral BI 1815368 compared to placebo in patients with diabetic macular edema over 48 weeks of treatment

This five-country European trial represents a significant development as it tests an oral tablet medication (BI 1815368) rather than eye injections. The study runs for 48 weeks and compares different doses of the medication against placebo.

Who can participate: Adults aged 18 or older with diabetes (type 1 or type 2), HbA1c less than 12%, stable diabetes medication for at least 30 days, and retinal swelling meeting specific thickness measurements (at least 320 micrometers for men, 305 micrometers for women). Vision must be between 24 and 78 letters on the eye chart.

Who cannot participate: Individuals over 75 years, pregnant or breastfeeding women, those with other serious eye conditions, uncontrolled diabetes, recent eye surgery, severe heart, kidney, or liver disease, or history of stroke or heart attack in the past six months.

Main focus: The study evaluates whether oral tablets can improve vision by 10 or more letters on the eye chart by week 48, while monitoring retinal thickness and overall safety.

Investigational drug: BI 1815368 is an experimental oral medication that could offer an alternative to current injectable treatments for managing retinal swelling.

Study Comparing OXU-001 and Intravitreal Dexamethasone for Patients with Diabetic Macular Edema

This Spanish-Hungarian trial compares a novel drug delivery system for dexamethasone called OXU-001 with the established OZURDEX implant. OXU-001 uses a special illuminated microcatheter device to deliver dexamethasone microspheres to the back of the eye in a minimally invasive way.

Who can participate: Adults aged 18 or older with type 1 or type 2 diabetes and confirmed retinal swelling affecting the central vision area. Vision in the study eye must be between 20/200 and 20/32. Female participants of childbearing potential must agree to effective contraception during the study and for 52 weeks after treatment. Male participants must use barrier contraception during the study and for 52 weeks afterward.

Who cannot participate: Those with other eye diseases affecting study results, recent eye surgery (within three months), current use of medications interfering with the study, history of severe allergic reactions, pregnant or breastfeeding women, participants in other trials within 30 days, uncontrolled diabetes, or serious health conditions making participation unsafe.

Main focus: The study compares the safety, tolerability, and effectiveness of the new OXU-001 delivery system with the traditional OZURDEX implant, monitoring how long treatment effects last and how often additional treatments are needed.

Investigational drugs: OXU-001 delivers dexamethasone using microspheres and a specialized device, while OZURDEX is an established implant placed directly into the eye. Both contain dexamethasone, a steroid that reduces inflammation and swelling.

Study on Aflibercept for Adults with Diabetic Macular Edema or Wet Age-Related Macular Degeneration

This trial in Hungary, Czechia, and Slovakia studies how the body processes aflibercept (also known as BAY 86-5321) when given at higher doses in both eyes. The study monitors blood levels of the medication to understand its absorption and processing.

Who can participate: Adults aged 18 or older (or the local age of majority if higher) who need anti-VEGF treatment in both eyes. Participants with diabetes and retinal swelling must have central retinal thickness of 300 micrometers or more (320 micrometers if measured with a specific device). Vision must be between 78 and 24 on the ETDRS chart (approximately 20/32 to 20/320). Female and male participants must agree to effective contraception during the study and for at least four months after the last treatment.

Who cannot participate: Those with other eye diseases affecting results, recent eye surgery, history of severe allergic reactions, current participation in other trials, uncontrolled high blood pressure, recent heart attack or stroke (within six months), pregnant or breastfeeding women, serious medical conditions interfering with the study, or inability to follow procedures or attend visits.

Main focus: The study assesses the maximum concentration of aflibercept in the blood when administered at high doses in both eyes, evaluating how the medication is processed and its safety profile.

Investigational drug: Aflibercept is administered through eye injections and works by blocking VEGF, a protein promoting abnormal blood vessel growth, thereby reducing swelling and preventing further vision loss.

Study on EYE103 and Ranibizumab for Patients with Diabetic Macular Edema

This extensive 12-country European trial is another study comparing EYE103 with ranibizumab (Lucentis) and includes a placebo group. The study lasts approximately one year with regular monitoring of vision and eye health.

Who can participate: Adults aged 18 or older who can understand study procedures and provide written consent. Female participants of childbearing potential must have negative pregnancy tests and agree to contraception for 30 days after the last dose. Male participants must be surgically sterile for at least 12 weeks or agree to use condoms plus another highly effective contraceptive method during the study and for 90 days after the last dose.

Who cannot participate: Patients without confirmed diagnosis, those outside the age range, and members of vulnerable populations.

Main focus: The trial measures vision changes using the ETDRS chart at 52 weeks, comparing EYE103’s effectiveness to ranibizumab in maintaining or improving vision.

Investigational drugs: EYE103 is administered as an eye injection at doses of either 0.5 mg or 0.8 mg, while ranibizumab is given at 0.5 mg. Both medications target proteins causing abnormal blood vessel growth in the eye. Fluorescein sodium may be used as a contrast agent during examinations to visualize eye blood vessels.

Study on the Effectiveness and Safety of OCS-01 Eye Drops with Dexamethasone for Patients with Diabetic Macular Edema

This Hungarian-Spanish trial tests OCS-01 eye drops containing dexamethasone in a two-stage study. The first stage determines the best dosing schedule, while the second stage compares the eye drops to placebo over 52 weeks in a double-masked design.

Who can participate: Adults aged 18 to 85 with type 1 or type 2 diabetes, HbA1c of 16% or less, and retinal swelling with central thickness of at least 310 micrometers measured by SD-OCT. Vision in the non-study eye must be better than 20/200, while the study eye must have vision between 20/50 and 20/320. If previously treated with anti-VEGF or corticosteroid injections, specific waiting periods apply (3 months for anti-VEGF, 4 months for triamcinolone, 6 months for Ozurdex, 3 years for non-biodegradable implants). Female participants of childbearing potential must have negative pregnancy tests and use effective contraception.

Who cannot participate: Those with other eye diseases, recent eye surgery (within 3 months), current use of other treatments, uncontrolled diabetes, history of severe allergies, pregnant or breastfeeding women, participation in other trials within 30 days, or serious health conditions interfering with the study.

Main focus: The study evaluates vision improvements measured by ETDRS letter scores at weeks 6 and 12 in Stage 1, and over 52 weeks in Stage 2, while also assessing changes in central retinal thickness.

Investigational drug: OCS-01 is an eye drop suspension designed to reduce inflammation and swelling in the retina through topical application rather than injection.

Study on the Effectiveness and Safety of OCS-01 Eye Drops with Dexamethasone for Patients with Diabetic Macular Edema

This six-country European trial (Bulgaria, Spain, Italy, Czechia, France, Germany) tests OCS-01 eye drops with dexamethasone against placebo over 52 weeks. The study aims to provide information on whether these eye drops can be a safe and effective treatment option.

Who can participate: Adults aged 18 to 85 with type 1 or type 2 diabetes, HbA1c of 10.0% or lower, and retinal swelling with central thickness of at least 310 micrometers. Vision in the non-study eye must exceed 20/200, while the study eye must have vision between 20/50 and 20/320. Previous treatments require specific waiting periods, and female participants of childbearing potential must have negative pregnancy tests and use effective contraception.

Who cannot participate: Individuals with other eye diseases, recent eye surgery (within 3 months), current use of other treatments, uncontrolled diabetes, severe allergic reactions history, pregnant or breastfeeding women, participation in other trials within 30 days, or serious health conditions.

Main focus: The trial measures the average change in vision using BCVA scores and monitors changes in retinal thickness over the 52-week period, while assessing safety through various tests including intraocular pressure and blood tests.

Investigational drug: OCS-01 is a Phase 3 investigational eye drop formulation that provides a targeted approach to reducing retinal swelling through anti-inflammatory action.

Study on the Safety and Use of AVT06 (Aflibercept) for Patients with Chorioretinal Vascular Diseases

This Latvian trial studies AVT06, a pre-filled syringe version of aflibercept, focusing on proper handling and safety when used for various eye conditions including diabetic macular edema. The study includes an optional extension phase for further observation.

Who can participate: Adults aged 18 or older with confirmed eye conditions requiring anti-VEGF treatment in both eyes, including those with diabetic retinal swelling (either type 1 or type 2 diabetes) with central retinal thickness of 300 micrometers or more. Vision in the study eye must be between 78 and 24 on the ETDRS chart (approximately 20/32 to 20/320). Female participants must not be pregnant or breastfeeding and must agree to effective contraception during the study and for at least 4 months after the last treatment. Male participants must also agree to contraception and must not donate sperm during the treatment period and for at least 3 months afterward.

Who cannot participate: Those with other eye diseases not part of the study, recent or planned eye surgery during the study period, current eye infections or inflammation, allergies to study medications, concurrent participation in other trials, serious illnesses affecting participation ability, pregnant or breastfeeding women, history of drug or alcohol abuse, or inability to follow study instructions or attend required visits.

Main focus: The study demonstrates proper handling of the pre-filled syringe and evaluates the safety of eye injections, monitoring for any side effects related to the eye from baseline to week 4 and assessing the proportion of successful injections.

Investigational drug: AVT06 is administered via pre-filled syringe for injection into the eye. It belongs to the anti-angiogenic class of medications, which inhibit the formation of new blood vessels by targeting pathways involved in abnormal blood vessel growth and leakage in the retina.

Summary

The 10 ongoing clinical trials for diabetic retinal oedema reflect diverse approaches to treatment, ranging from traditional eye injections to innovative eye drops and oral medications. The trials are most concentrated in Central and Western Europe, with Germany, France, Spain, Hungary, and Czechia hosting multiple studies.

Several trials focus on comparing new medications like EYE103 with established treatments such as ranibizumab, with two large international studies spanning 12 European countries. The development of oral medication (BI 1815368) represents a potentially significant advancement, as it could eliminate the need for eye injections. Additionally, multiple studies are investigating eye drop formulations (OCS-01) containing dexamethasone, offering another non-invasive treatment option.

Treatment approaches include anti-VEGF medications that block proteins causing abnormal blood vessel growth, corticosteroid implants and eye drops that reduce inflammation, and novel drug delivery systems like the OXU-001 microsphere technology. Most trials run for 48 to 52 weeks, with one three-year study comparing implant cost-effectiveness.

Eligibility criteria generally require adults aged 18 or older with confirmed diabetes (type 1 or type 2) and specific measurements of retinal thickness and vision levels. Common exclusion factors include other serious eye diseases, recent eye surgery, uncontrolled diabetes, pregnancy, and serious health conditions. The trials emphasize contraception requirements for participants of childbearing potential, typically during the study period and for several months after the last treatment.

Ongoing Clinical Trials on Diabetic retinal oedema

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