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

What is this study about?

This study focuses on diabetic macular edema, a condition affecting the eyes of people with diabetes that causes swelling in the central part of the retina. The research evaluates a new medication called BI 1815368 taken as oral tablets, which is being tested to determine if it can help improve vision in people with this eye condition.

The purpose of this research is to understand how different doses of BI 1815368 affect vision improvement in people who have varying levels of vision problems due to diabetic macular edema. The study will compare the new medication to placebo over a treatment period of 48 weeks.

During the study, participants will take tablets by mouth and have their vision regularly checked. The research team will monitor how well participants can see using standard eye tests and measure the thickness of the retina using special imaging equipment. They will also keep track of any effects that might be related to the treatment to ensure participant safety throughout the study period.

1 Initial assessment

You will undergo an eye examination to confirm the presence of diabetic macular edema, a condition where fluid builds up in the central part of the retina.

Your vision will be tested using special ETDRS charts (standard eye test charts) to measure your current vision level.

A scan called SD-OCT will be performed to measure the thickness of your retina.

2 Treatment assignment

You will be randomly assigned to receive either BI 1815368 tablets or placebo tablets (tablets with no active medication).

Neither you nor your doctor will know which treatment you are receiving during the study.

3 Treatment period

The treatment period will last for 48 weeks (approximately 11 months).

You will take the assigned tablets by mouth according to the prescribed schedule.

Your diabetes medication must remain stable throughout the study period.

4 Regular monitoring

Regular eye examinations will be conducted to measure your vision using the ETDRS charts.

Retinal thickness measurements will be taken using SD-OCT scans.

Your overall health and any side effects will be monitored throughout the study.

5 Final assessment

At week 48, final measurements of your vision will be taken to determine if there has been an improvement of 10 or more letters on the eye chart.

A final retinal thickness measurement will be performed.

Any side effects that occurred during the study will be reviewed.

Who Can Join the Study?

Must be at least 18 years old
Must have been diagnosed with diabetes (either type 1 or type 2) with:
- Blood sugar control test (HbA1c) less than 12%
- Stable diabetes medication for at least 30 days before starting the study
- No planned major changes to diabetes medication
Must have diabetic macular edema (swelling in the central part of the retina) that meets specific thickness measurements:
- For men: at least 320 micrometers
- For women: at least 305 micrometers
Must have specific levels of vision in the study eye, measured using a standard eye chart (ETDRS):
- Vision must be between 24 and 78 letters on the eye chart
- This is approximately equal to vision between 20/320 and 20/32 on a standard vision test
Additional eligibility requirements may apply

Who Cannot Join the Study?

Age under 18 years or over 75 years
Pregnancy or breastfeeding
History of macular degeneration (damage to the central part of the retina) other than diabetic macular edema
Active eye infection or inflammation
Previous eye surgery within the last 3 months
Uncontrolled diabetes (blood sugar levels that remain high despite treatment)
Presence of other serious eye conditions such as glaucoma (increased pressure in the eye)
History of blood clotting disorders
Current participation in other clinical trials
Known allergies to similar medications
Severe heart, kidney, or liver disease
History of stroke or heart attack in the past 6 months
Use of blood thinning medications
Mental conditions that could affect ability to provide informed consent
Any condition that, in the opinion of the investigator, would make participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Universitaet Leipzig	Leipzig	Germany
Technische Universitaet Dresden	Dresden	Germany

Other Sites

Site Name	City	Country
F D Roosevelt University General Hospital Of Banska Bystrica	Banska Bystrica	Slovakia
Eb Group Sp. z o.o.	Warsaw	Poland
Clinical Medical Research Sp. z o.o.	Katowice	Poland
Warszawski Szpital Okulistyczny Sp. z o.o.	Warsaw	Poland
Oftex s.r.o.	Pardubice	Czechia
Augenzentrum Am St Franziskus-Hospital Muenster	Munster	Germany
Centrum Diagnostyki I Mikrochirurgii Oka Lens Sp. z o.o.	Olsztyn	Poland
Fakultna Nemocnica Trencín	Trencin	Slovakia
University Of Debrecen	Debrecen	Hungary
University Teaching Hospital Markusovszky	Szombathely	Hungary
Bajcsy-Zsilinszky Korhaz Es Rendelointezet	Budapest	Hungary
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Fakultni Nemocnice Kralovske Vinohrady	Prague	Czechia
Fakultna Nemocnica S Poliklinikou Zilina	Zilina	Slovakia
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Jahn Ferenc Del-Pesti Korhaz Es Rendelointezet	Budapest	Hungary
University Of Pecs	Pecs	Hungary
Fakultni Thomayerova nemocnice	Prague	Czechia
University Of Szeged	Szeged	Hungary
University Hospital Ostrava	Ostrava	Czechia
Budapest Retina Associates	Budapest	Hungary
Aqtk Caxpiuvf sptdju	Prague	Czechia
Gylrcekt Olchiz Kzhvrmd	Pecs	Hungary
Édbjsjyjygn Corfngefxwyngydbwadfvlfwwz	Budapest	Hungary
Czniona Mzafwyls Dmtjkd 1o Srh z oukk	Cracow	Poland
Sfkzwke Skjwhtii Lauplyd Sbiz	Bielsko-Biala	Poland
Pttazjrvxg Cefxpcm Watkup Mgvpe Mddfuj Mxegyhd Mgbghi Sbn jt	Poznan	Poland
Chxcnnevq Swr z ohcq	Tarnowskie Gory	Poland
Ornanvqbshp Sqi z ocbt	Bydgoszcz	Poland
Ntayxrcbx S Pujizqwacqzs Tqellxlu anog	Trebisov	Slovakia
Siocnzg Szq Ryoe Sox z otaz Sojy	Cracow	Poland
Uzuzmxlkafflmapwchllp Dpdzoyovihi Auk	Duesseldorf	Germany

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	01.10.2025
Germany	Not yet recruiting	01.10.2025
Hungary	Recruiting	01.10.2025
Poland	Recruiting	01.10.2025
Slovakia	Recruiting	01.10.2025

Trial locations

Based on the provided trial data, only one medication is mentioned:

BI 1815368 is an oral medication being tested for treating diabetic macular edema (DME), a condition where fluid builds up in the center of the retina causing vision problems in people with diabetes. This is a new investigational drug that is taken by mouth, which is notable because most current treatments for DME are given as eye injections.

Centre-involved diabetic macular edema – A condition that occurs when blood vessels in the central part of the retina (macula) become damaged due to diabetes, causing them to leak fluid. This fluid accumulation leads to swelling in the central portion of the retina, affecting the area responsible for detailed vision. The condition typically develops gradually in people who have diabetic retinopathy. As the fluid builds up in the macula, it causes distortion of central vision and can make everyday tasks like reading or recognizing faces more difficult. The condition can affect one or both eyes.

Trial ID:

2024-520384-14-00

Protocol code:

1485-0018

NCT ID:

NCT06962839

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?