Age-Related Macular Degeneration (ARMD) Clinical Trials

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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)

Status: Recruiting
Location: See all (69) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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. 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 16 times. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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 for male and ≥305 µm for female participants 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.

Locations
United States
California
Win Retina
NOT_YET_RECRUITING
Arcadia
Retinal Consultants Medical Group, Inc
NOT_YET_RECRUITING
Modesto
Doheny Eye Center UCLA Arcadia
NOT_YET_RECRUITING
Pasadena
Retina Consultants of San Diego
NOT_YET_RECRUITING
Poway
West Coast Retina Medical Group, Inc.
NOT_YET_RECRUITING
San Francisco
Colorado
Colorado Retina Associates
NOT_YET_RECRUITING
Lakewood
Florida
Advanced Research Institute
RECRUITING
Pompano Beach
Center for Retina and Macular Disease
NOT_YET_RECRUITING
Winter Haven
Indiana
Associated Vitreoretinal and Uveitis Consultants
NOT_YET_RECRUITING
Carmel
Kansas
University of Kansas Medical Center
NOT_YET_RECRUITING
Kansas City
Maryland
Cumberland Valley Retina Consultants, PC.
NOT_YET_RECRUITING
Hagerstown
North Carolina
North Carolina Retina Associates
NOT_YET_RECRUITING
Wake Forest
Oregon
Verum Research, LLC
NOT_YET_RECRUITING
Eugene
Tennessee
Tennessee Retina
NOT_YET_RECRUITING
Nashville
Texas
Austin Clinical Research, LLC
NOT_YET_RECRUITING
Austin
Austin Research Center for Retina, PLLC
NOT_YET_RECRUITING
Austin
Austin Retina Associates
NOT_YET_RECRUITING
Austin
Texas Retina Associates
RECRUITING
Dallas
Retina Center Of Texas
NOT_YET_RECRUITING
Southlake
Retina Consultants Of Texas
NOT_YET_RECRUITING
The Woodlands
Other Locations
China
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
Shanghai General Hospital
NOT_YET_RECRUITING
Shanghai
The Fourth People's Hospital of Shenyang
NOT_YET_RECRUITING
Shenyang
Shijiazhuang People's Hospital
NOT_YET_RECRUITING
Shijiazhuang
Shanxi Eye Hospital
NOT_YET_RECRUITING
Taiyuan
Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
NOT_YET_RECRUITING
Dresden
Universitätsklinikum Düsseldorf
NOT_YET_RECRUITING
Düsseldorf
Universitätsklinikum Leipzig
NOT_YET_RECRUITING
Leipzig
Universitätsklinikum Mannheim GmbH
NOT_YET_RECRUITING
Mannheim
Augenzentrum am St. Franziskus-Hospital Münster
NOT_YET_RECRUITING
Münster
Hungary
Budapest Retina Associations Kft.
NOT_YET_RECRUITING
Budapest
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
NOT_YET_RECRUITING
Budapest
Budapesti Jahn Ferenc Del-pesti Korhaz es Rendelointezet
NOT_YET_RECRUITING
Budapest
Central Hospital of Northern Pest - Military Hospital
NOT_YET_RECRUITING
Budapest
University of Debrecen
NOT_YET_RECRUITING
Debrecen
Nozologen Kft.
NOT_YET_RECRUITING
Pécs
University of Pecs
NOT_YET_RECRUITING
Pécs
University of Szeged
NOT_YET_RECRUITING
Szeged
Japan
Asahikawa Medical University Hospital
NOT_YET_RECRUITING
Asahikawa-shi
Tokyo Medical University Hachioji Medical Center
NOT_YET_RECRUITING
Hachioji-shi
Kagawa University Hospital
NOT_YET_RECRUITING
Kita-gun
Kurume University Hospital
NOT_YET_RECRUITING
Kurume-shi
Shinshu University Hospital
NOT_YET_RECRUITING
Matsumoto-shi
National Hospital Organization Tokyo Medical Center
NOT_YET_RECRUITING
Meguro-ku
Nagoya City University Hospital
NOT_YET_RECRUITING
Nagoya
Tokyo Women's Medical University Hospital
NOT_YET_RECRUITING
Shinjuku-ku
Juntendo University Urayasu Hospital
NOT_YET_RECRUITING
Urayasu-shi
Poland
Szpital Swietego Lukasza S. A.
NOT_YET_RECRUITING
Bielsko-biala
Oculomedica Sp. z o.o.
NOT_YET_RECRUITING
Bydgoszcz
Clinical Medical Research Sp. z o.o.
NOT_YET_RECRUITING
Katowice
Centrum Medyczne Dietla 19 Sp. z o.o.
NOT_YET_RECRUITING
Krakow
Szpital Sw. Rozy Sp. z o.o.
NOT_YET_RECRUITING
Krakow
Centrum Diagnostyki i Mikrochirurgii Oka-Lens Sp. z o.o.
NOT_YET_RECRUITING
Olsztyn
Poznanskie Centrum Wzroku sp z o o
NOT_YET_RECRUITING
Poznan
Caminomed Sp. z o.o.
NOT_YET_RECRUITING
Tarnowskie Góry
Eb Group Sp. z o.o.
NOT_YET_RECRUITING
Warsaw
Warszawski Szpital Okulistyczny Sp. z o.o.
NOT_YET_RECRUITING
Warsaw
Slovakia
F D Roosevelt University General Hospital Of Banska Bystrica
NOT_YET_RECRUITING
Banská Bystrica
Nemocnica s poliklinikou Trebisov a.s.
NOT_YET_RECRUITING
Trebišov
Fakultna nemocnica s poliklinikou Zilina
NOT_YET_RECRUITING
Žilina
United Kingdom
Frimley Park Hospital NHS Foundation Trust
NOT_YET_RECRUITING
Frimley
Gloucestershire Royal Hospital
NOT_YET_RECRUITING
Gloucester
Northwick Park Hospital
NOT_YET_RECRUITING
Harrow
Royal Liverpool University Hospital
NOT_YET_RECRUITING
Liverpool
King's College Hospital
NOT_YET_RECRUITING
London
Moorfields Eye Hospital
NOT_YET_RECRUITING
London
Royal Victoria Infirmary
NOT_YET_RECRUITING
Newcastle Upon Tyne
Sunderland Eye Infirmary
NOT_YET_RECRUITING
Sunderland
Southend University Hospital
NOT_YET_RECRUITING
Westcliff-on-sea
Contact Information
Primary
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127
Time Frame
Start Date: 2025-06-05
Estimated Completion Date: 2027-09-29
Participants
Target number of participants: 300
Treatments
Experimental: Cohort 1: Treatment arm
Placebo_comparator: Cohort 1: Placebo arm
Placebo_comparator: Cohort 2: Placebo arm
Experimental: Cohort 2: Treatment arm, low dose
Experimental: Cohort 2: Treatment arm, medium dose
Experimental: Cohort 2: Treatment arm, high dose
Related Therapeutic Areas
Diabetic Macular Edema (DME)
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: Boehringer Ingelheim

This content was sourced from clinicaltrials.gov

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