Macular EdemaPhase 2NCT06962839
A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema
A Phase 2 study testing BI 1815368 in people with Macular Edema, run by Boehringer Ingelheim at 97 sites in 9 countries.
Trial summary
This study is open to adults 18 and older with an eye condition called diabetic macular edema. People are required to have a specific type of diabetic macular edema called centre-involved diabetic macular edema (CI-DME) to take part. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema
- What is being tested?
- BI 1815368
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 97 sitesin 9 countries
- Study dates
- 5 Jun 2025to 29 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Diagnosis of diabetes mellitus (DM) (type 1 or type 2), Haemoglobin A1C (HbA1c) <12% treated with stable medication for at least 30 days prior to Day 1; no already-set plans for major changes in DM medication (e.g. start of new medication) at the time of screening and baseline
- Centre-involved diabetic macular edema (CI-DME) confirmed on spectral domain optical coherence tomography (SD-OCT) with central subfield foveal thickness (CST) ≥320 µm in the study eye at screening
- Best corrected visual acuity (BCVA) visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye between 24 and 78 (Snellen equivalent range 20/320 to 20/32) at screening Further inclusion criteria apply.
Who cannot join
- Macular edema considered to be due to other causes than CI-DME in the study eye
- Proliferative diabetic retinopathy or iris neovascularisation (including the anterior chamber angle) in the study eye
- Intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) treatment in the study eye is not allowed within 8 weeks prior to Day 1, except for faricimab or aflibercept 8 mg, for which a 16-week washout period prior to Day 1 is required. There is no limit on the total number of prior IVT antiVEGF injections, provided that the subject has demonstrated a response to prior antiVEGF treatment (at the investigator's discretion) and the anatomical integrity is confirmed by the central reading centre (CRC) at screening based on spectral domain optical coherence tomography (SD-OCT).
- Any history of panretinal photocoagulation, vitreoretinal surgery, IVT or periocular corticosteroid treatment (within 12 months before Day 1), history of fluocinolone ophthalmic implant or dexamethasone IVT implant before Day 1, or topical steroid or nonsteroidal anti-inflammatory drug (NSAID) treatment (within 30 days before Day 1)
- Prior macular laser photocoagulation performed more than 3 months prior to Day 1 is permitted if absence of scar-like changes within the 1-mm diameter region centred on the fovea is confirmed by the CRC at screening based on SD-OCT
- Active ocular inflammation or any history of intraocular inflammation within 1 year
- Aphakia or total absence of the posterior capsule; Yttrium aluminium garnet (YAG) laser capsulotomy in the study eye is permitted if more than 2 months prior to Day 1 Further exclusion criteria apply.
Trial locations and contacts
97 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
97 sites in 9 countries
United States37 sites, 37 recruiting
- Recruiting
Win Retina
Arcadia, California, 91006
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Southeast Retina Center, PC
Augusta, Georgia, 30909
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Austin Research Center for Retina, PLLC
Austin, Texas, 78705
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Austin Retina Associates
Austin, Texas, 78705
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Austin Retina Associates
Austin, Texas, 78705
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Austin Clinical Research, LLC
Austin, Texas, 78750
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Retina Consultants of Texas - Beaumont
Beaumont, Texas, 77707
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Associated Vitreoretinal and Uveitis Consultants
Carmel, Indiana, 46032
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Retina Consultants, PLLC
Charleston, West Virginia, 25301
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Texas Retina Associates
Dallas, Texas, 75231
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Connecticut Eye Consultants, PC
Danbury, Connecticut, 06810
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Verum Research, LLC
Eugene, Oregon, 97401
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Retina Group of Florida - Fort Lauderdale Retina Center
Fort Lauderdale, Florida, 33308
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Retina Consultants of Carolina, P.A.
Greenville, South Carolina, 29605
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Retina Associates of Southern California
Huntington Beach, California, 92647
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Florida Retina Institute, Jacksonville Southside
Jacksonville, Florida, 32216
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Colorado Retina Associates
Lakewood, Colorado, 80228
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Piedmont Eye Center
Lynchburg, Virginia, 24502
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Retinal Consultants Medical Group, Inc
Modesto, California, 95356
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Tennessee Retina
Nashville, Tennessee, 37203
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Eye Research Foundation
Newport Beach, California, 92663
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Doheny Eye Center UCLA Arcadia
Pasadena, California, 91103
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Arizona Retina & Vitreous Research, Central Phoenix
Phoenix, Arizona, 85016
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Advanced Research Institute
Pompano Beach, Florida, 33064
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Retina Consultants of San Diego
Poway, California, 92064
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Sierra Eye Associates
Reno, Nevada, 89502
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Retinal Consultants of San Antonio
San Antonio, Texas, 78240
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
West Coast Retina Medical Group, Inc.
San Francisco, California, 94109
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Retina Center Of Texas
Southlake, Texas, 76092
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
East Florida Eye Institute
Stuart, Florida, 34994
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Retina Consultants of Texas
The Woodlands, Texas, 77384
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
North Carolina Retina Associates
Wake Forest, North Carolina, 27587
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Center for Retina and Macular Disease
Winter Haven, Florida, 33880
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Japan12 sites, 12 recruiting
- Recruiting
Asahikawa Medical University Hospital
Asahikawa-shi, 078-8510
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Chofu Eye Clinic
Chofu-shi, 182-0024
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Tokyo Medical University Hachioji Medical Center
Hachioji-shi, 193-0998
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Tokiwadai Muranaka Eye Clinic
Itabashi-ku, 174-0071
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Kagawa University Hospital
Kita-gun, 761-0793
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Kurume University Hospital
Kurume-shi, 830-0011
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Shinshu University Hospital
Matsumoto-shi, 390-8621
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
National Hospital Organization Tokyo Medical Center
Meguro-ku, 152-8902
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Nagoya City University Hospital
Nagayoga, 467-8602
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Musashi Dream Eye Clinic
Osaka, 543-0027
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Tokyo Women's Medical University Hospital
Tokyo, 162-8666
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
Juntendo University Urayasu Hospital
Urayasu-shi, 279-0021
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Poland10 sites, 10 recruiting
- Recruiting
Szpital Swietego Lukasza S. A.
Bielsko-Biala, 43-309
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Recruiting
Oculomedica Sp. z o.o.
Bydgoszcz, 85-157
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Recruiting
Clinical Medical Research Sp. z o.o.
Katowice, 40-156
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Recruiting
Szpital Sw. Rozy Sp. z o.o.
Krakow, 30-394
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Recruiting
Centrum Medyczne Dietla 19 Sp. z o.o.
Krakow, 31-070
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Recruiting
Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
Olsztyn, 10-424
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Recruiting
Poznanskie Centrum Wzroku sp z o o
Poznan, 60-538
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Recruiting
Caminomed Sp. z o.o.
Tarnowskie Góry, 42-600
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Recruiting
Eb Group Sp. z o.o.
Warsaw, 00-189
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
- Recruiting
Warszawski Szpital Okulistyczny Sp. z o.o.
Warsaw, 01-258
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
United Kingdom9 sites, 9 recruiting
- Recruiting
Frimley Park Hospital
Camberley, GU16 7UJ
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
Gloucestershire Royal Hospital
Gloucester, GL1 3NN
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
Northwick Park Hospital
Harrow, HA1 3UJ
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
Royal Liverpool University Hospital
Liverpool, L7 8XP
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
Moorfields Eye Hospital
London, EC1V 2PD
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
King's College Hospital
London, SE5 9RS
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
Sunderland Eye Infirmary
Sunderland, SR2 9HP
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Recruiting
Southend University Hospital
Westcliff-on-Sea, SS0 0RY
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Hungary8 sites, 8 recruiting
- Recruiting
Central Hospital of Northern Pest - Military Hospital
Budapest, 1068
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Recruiting
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
Budapest, 1106
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Recruiting
Budapest Retina Associations Kft.
Budapest, 1133
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Recruiting
Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest, 1204
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Recruiting
University of Debrecen
Debrecen, 4032
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Recruiting
Nozologen Kft.
Pécs, 7621
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Recruiting
University of Pecs
Pécs, 7623
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
- Recruiting
University of Szeged
Szeged, 6720
Boehringer Ingelheim, 680017725, magyarorszag@bitrialsupport.com
Czechia7 sites, 7 recruiting
- Recruiting
University Hospital Hradec Kralove (FNHK)
Hradec Králové, 500 03
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Recruiting
University Hospital Ostrava
Ostrava-Poruba, 708 52
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Recruiting
Oftex s.r.o.
Pardubice, 530 02
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Recruiting
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 00
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Recruiting
Vseobecna Fakultni Nemocnice V Praze
Prague, 128 00
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Recruiting
Fakultni Thomayerova nemocnice
Prague, 140 59
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
- Recruiting
Axon Clinical s.r.o.
Prague, 150 00
Boehringer Ingelheim, 00441144040048, support@bitrialsupport.com
China5 sites, 5 recruiting
- Recruiting
West China Hospital, Sichuan University
Chengdu, 610041
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shanghai General Hospital
Shanghai, 200080
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The Fourth People's Hospital of Shenyang
Shenyang, 110031
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shijiazhuang People's Hospital
Shijiazhuang, 050011
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Shanxi Eye Hospital
Taiyuan, 030072
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Germany5 sites, 5 recruiting
- Recruiting
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Leipzig
Leipzig, 04103
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Universitätsklinikum Mannheim GmbH
Mannheim, 68167
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Augenzentrum am St. Franziskus-Hospital Münster
Münster, 48145
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Slovakia4 sites, 4 recruiting
- Recruiting
F D Roosevelt University General Hospital Of Banska Bystrica
Banská Bystrica, 974 01
Boehringer Ingelheim, 0800002662, slovensko@bitrialsupport.com
- Recruiting
Nemocnica s poliklinikou Trebisov a.s.
Trebišov, 075 01
Boehringer Ingelheim, 0800002662, slovensko@bitrialsupport.com
- Recruiting
Fakultna nemocnica Trencin
Trenčín, 911 01
Boehringer Ingelheim, 0800002662, slovensko@bitrialsupport.com
- Recruiting
Fakultna nemocnica s poliklinikou Zilina
Žilina, 101 01
Boehringer Ingelheim, 0800002662, slovensko@bitrialsupport.com
About this study
Official title: A Randomised, Double-masked, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Oral BI 1815368 in Participants With Centre-involved Diabetic Macular Edema for 48 Weeks of Treatment (THULITE)
This study is open to adults 18 and older with an eye condition called diabetic macular edema. People are required to have a specific type of diabetic macular edema called centre-involved diabetic macular edema (CI-DME) to take part. The purpose of this study is to find out whether a medicine called BI 1815368 improves sight in people with CI-DME and to find the most suitable dose.
This study has 2 parts. In the first part, participants are put into 2 groups of equal size randomly, which means by chance. One group takes BI 1815368 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1815368 tablets but do not contain any medicine. In the second part, participants are put into 4 groups of equal size randomly. 3 groups take different daily doses of the study medicine, BI 1815368, while 1 group takes placebo. All participants take tablets twice a day for about 11 months.
Participants are in the study for about 1 year. During this time, they visit the study site at least 16 times. Participants taking metformin have 3 additional study visits. At visits, doctors check the participant's vision and collect information on any health problems. They take detailed pictures of the eye. The changes over time are compared between the groups to see if the treatment works.
- Conditions
- Macular Edema
- Being tested
- BI 1815368, Placebo
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1815368Drug
BI 1815368
PlaceboDrug
Placebo matching BI 1815368
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Treatment arm | Experimental | Not described Receives: Drug: BI 1815368 |
| Cohort 1: Placebo arm | Placebo comparator | Not described Receives: Drug: Placebo |
| Cohort 2: Placebo arm | Placebo comparator | Not described Receives: Drug: Placebo |
| Cohort 2: Treatment arm, low dose | Experimental | Not described Receives: Drug: BI 1815368 |
| Cohort 2: Treatment arm, medium dose | Experimental | Not described Receives: Drug: BI 1815368 |
| Cohort 2: Treatment arm, high dose | Experimental | Not described Receives: Drug: BI 1815368 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence (yes/no) of a gain of ≥10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters compared with baseline in the study eye at Week 48
With ETDRS letters, the number of letters a patient can correctly read on an ETDRS chart from a distance of 4 meters is measured.
Measured: at baseline, at week 48
Secondary outcomes (3)
Occurrence (yes/no) of gain of ≥15 ETDRS letters compared with baseline in the study eye at Week 48
With ETDRS letters, the number of letters a patient can correctly read on an ETDRS chart from a distance of 4 meters is measured.
Measured: at baseline, at week 48
Occurrence (yes/no) of adverse events (AEs) between the first investigational medicinal product (IMP) dose and end of study (EoS)
Measured: up to 52 weeks
Absolute change from baseline in central subfield foveal thickness (CST) as measured by spectral domain optical coherence tomography (SD-OCT) in the study eye at Week 48
Measured: at baseline, at week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start5 Jun 2025
- Primary completion1 Mar 2028 (estimated)
- Study completion29 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants in Cohort 1 will be randomised in a 1:1 ratio to placebo or BI 1815368 group. Once Cohort 1 is fully recruited, Cohort 2 will be randomised in a 1:1:1:1 ratio to placebo or BI 1815368 low/medium/high dose groups. There is no planned pause in recruitment between Cohort 1 and Cohort 2.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962839
- Sponsor's protocol ID
- 1485-0018
- Other IDs
- U1111-1317-2206, 2024-520384-14-00
- Status last verified
- Oct 2026
- First submitted
- 30 Apr 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-masked, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Oral BI 1815368 in Participants With Centre-involved Diabetic Macular Edema for 48 Weeks of Treatment (THULITE)
- ClinicalTrials.gov ID
- NCT06962839
- Acronym / sponsor ID
- 1485-0018
- Conditions
- Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 29 Mar 2028 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is open to adults 18 and older with an eye condition called diabetic macular edema. People are required to have a specific type of diabetic macular edema called centre-involved diabetic macular edema (CI-DME) to take part. The purpose of this study is to find out whether a medicine called BI 1815368 improves sight in people with CI-DME and to find the most suitable dose.
This study has 2 parts. In the first part, participants are put into 2 groups of equal size randomly, which means by chance. One group takes BI 1815368 tablets and the other group takes placebo tablets. Placebo tablets look like BI 1815368 tablets but do not contain any medicine. In the second part, participants are put into 4 groups of equal size randomly. 3 groups take different daily doses of the study medicine, BI 1815368, while 1 group takes placebo. All participants take tablets twice a day for about 11 months.
Participants are in the study for about 1 year. During this time, they visit the study site at least 16 times. Participants taking metformin have 3 additional study visits. At visits, doctors check the participant's vision and collect information on any health problems. They take detailed pictures of the eye. The changes over time are compared between the groups to see if the treatment works.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Participants in Cohort 1 will be randomised in a 1:1 ratio to placebo or BI 1815368 group. Once Cohort 1 is fully recruited, Cohort 2 will be randomised in a 1:1:1:1 ratio to placebo or BI 1815368 low/medium/high dose groups. There is no planned pause in recruitment between Cohort 1 and Cohort 2.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Treatment arm | Experimental | Drug: BI 1815368 |
| Cohort 1: Placebo arm | Placebo comparator | Drug: Placebo |
| Cohort 2: Placebo arm | Placebo comparator | Drug: Placebo |
| Cohort 2: Treatment arm, low dose | Experimental | Drug: BI 1815368 |
| Cohort 2: Treatment arm, medium dose | Experimental | Drug: BI 1815368 |
| Cohort 2: Treatment arm, high dose | Experimental | Drug: BI 1815368 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years of age
- Diagnosis of diabetes mellitus (DM) (type 1 or type 2), Haemoglobin A1C (HbA1c) <12% treated with stable medication for at least 30 days prior to Day 1; no already-set plans for major changes in DM medication (e.g. start of new medication) at the time of screening and baseline
- Centre-involved diabetic macular edema (CI-DME) confirmed on spectral domain optical coherence tomography (SD-OCT) with central subfield foveal thickness (CST) ≥320 µm in the study eye at screening
- Best corrected visual acuity (BCVA) visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye between 24 and 78 (Snellen equivalent range 20/320 to 20/32) at screening Further inclusion criteria apply.
Key exclusion criteria (7 listed)
- Macular edema considered to be due to other causes than CI-DME in the study eye
- Proliferative diabetic retinopathy or iris neovascularisation (including the anterior chamber angle) in the study eye
- Intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) treatment in the study eye is not allowed within 8 weeks prior to Day 1, except for faricimab or aflibercept 8 mg, for which a 16-week washout period prior to Day 1 is required. There is no limit on the total number of prior IVT antiVEGF injections, provided that the subject has demonstrated a response to prior antiVEGF treatment (at the investigator's discretion) and the anatomical integrity is confirmed by the central reading centre (CRC) at screening based on spectral domain optical coherence tomography (SD-OCT).
- Any history of panretinal photocoagulation, vitreoretinal surgery, IVT or periocular corticosteroid treatment (within 12 months before Day 1), history of fluocinolone ophthalmic implant or dexamethasone IVT implant before Day 1, or topical steroid or nonsteroidal anti-inflammatory drug (NSAID) treatment (within 30 days before Day 1)
- Prior macular laser photocoagulation performed more than 3 months prior to Day 1 is permitted if absence of scar-like changes within the 1-mm diameter region centred on the fovea is confirmed by the CRC at screening based on SD-OCT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 1815368BI 1815368 | Drug | Cohort 1: Treatment arm, Cohort 2: Treatment arm, high dose, Cohort 2: Treatment arm, low dose, Cohort 2: Treatment arm, medium dose |
| PlaceboPlacebo matching BI 1815368 | Drug | Cohort 1: Placebo arm, Cohort 2: Placebo arm |
Primary outcome
Occurrence (yes/no) of a gain of ≥10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters compared with baseline in the study eye at Week 48
Time frame: at baseline, at week 48
With ETDRS letters, the number of letters a patient can correctly read on an ETDRS chart from a distance of 4 meters is measured.
3 secondary outcomes
Occurrence (yes/no) of gain of ≥15 ETDRS letters compared with baseline in the study eye at Week 48
Time frame: at baseline, at week 48
Occurrence (yes/no) of adverse events (AEs) between the first investigational medicinal product (IMP) dose and end of study (EoS)
Time frame: up to 52 weeks
Absolute change from baseline in central subfield foveal thickness (CST) as measured by spectral domain optical coherence tomography (SD-OCT) in the study eye at Week 48
Time frame: at baseline, at week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
97 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 1815368 in people with Macular Edema, run by Boehringer Ingelheim at 97 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 97 sites in United States, Japan, Poland, United Kingdom, Hungary and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence (yes/no) of a gain of ≥10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters compared with baseline in the study eye at Week 48 (time frame: at baseline, at week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.