Abstract
Summary
This paper describes the results of a clinical trial called HORNBILL that were published in a scientific journal called Ophthalmology Science. In HORNBILL, researchers looked at a new drug called BI 764524 in the treatment of diabetic macular ischemia (DMI). DMI is a condition that affects people living with diabetes. For people living with DMI, there is reduced blood flow in the center of the retina (an area at the back of the eye that changes light into signals to allow people to see). Reduced blood flow means that the retina does not function correctly and vision can get worse. There are no available treatments for people with DMI, so it is important that research is carried out to find possible new drugs. BI 764524 was injected into the eyes of 33 people with DMI. This paper describes whether there were any safety-related events that might stop BI 764524 being tested in more trials and if it helped people in the trial.
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Footnotes
Acknowledgements
Medical writing support was provided by Rebecca Newman, MSc, of Omnicom Health Medical Communications (London, UK), which was contracted and funded by Boehringer Ingelheim in accordance with Good Publication Practice guidelines (
). Boehringer Ingelheim was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations. The authors would like to thank Serge Kosobokovs at Boehringer Ingelheim for his review of this manuscript and for his assistance in aligning the safety data reporting with the original publication. Boehringer Ingelheim would also like to thank everyone who took part in the study.
Ethics approval and consent to participate
The trial design was approved by the appropriate institutional and national regulatory authorities and ethics committees; all people recruited to the trial provided written informed consent. IRB/IECs who provided approval were South Central - Oxford B REC (IRAS ID: 278921; REC Reference: 20/SC/010), Advarra Institutional Review Board (FWA00023875), Cleveland Clinic (FWA00005367), Joslin Diabetes Center (FWA00001535) and Stanford University Medical Center (FWA00000934).
Consent for publication
Patients provided consent for their trial data to be used in future publications.
Author contributions
Chirag Jhaveri and Khaled Nassar: methodology; formal analysis; writing – original draft; writing – review and editing. Daniel Newman: writing – original draft; writing – review and editing
Funding
This study was supported and funded by Boehringer Ingelheim.
Competing interests
The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE) and did not receive payment related to development of this manuscript. Chirag Jhaveri reports financial support from Boehringer Ingelheim, Genentech, Gyroscope Therapeutics, Iveric Bio, Kodiak Sciences, Novartis, ONL Therapeutics, and RegenxBio; working as a consultant for Iveric Bio and Regeneron, and receipt of honoraria from Iveric Bio and Regeneron. Daniel Newman reports no conflicts of interest. Khaled Nassar is a current employee of Boehringer Ingelheim.
Availability of data and materials
To ensure independent interpretation of clinical study results and enable authors to fulfil their role and obligations under the ICMJE criteria, Boehringer Ingelheim grants all external authors access to relevant clinical study data. In adherence with the Boehringer Ingelheim Policy on Transparency and Publication of Clinical Study Data, scientific and medical researchers can request access to clinical study data, typically 1 year after the approval has been granted by major Regulatory Authorities or after termination of the development program. Researchers should use the https://vivli.org/ link to request access to study data and visit for further information.
Open access
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