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The HORNBILL study: A Phase I/IIa trial examining BI-X in patients with diabetic macular ischemia
Chirag Jhaveri, MD
Chirag Jhaveri, Quan Dong Nguyen, Sobha Sivaprasad, Maged Habib, Andrea Giani, Elizabeth Pearce
1. Chirag Jhaveri:
Retina Consultants of Austin, Austin, TX, USA
Austin Research Center for Retina, Dell Medical School, Austin, TX, USA
2. Quan Dong Nguyen:
Byers Eye Institute, Stanford University School of Medicine, Stanford, CA, USA
3. Sobha Sivaprasad:
NIHR Moorfields Biomedical Research Centre, London, UK
4. Maged Habib:
South Tyneside and Sunderland NHS Foundation Trust, Sunderland, UK
5. Andrea Giani:
Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany
6. Elizabeth Pearce:
Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA
Purpose: Diabetic macular ischemia (DMI) is a complication of diabetic retinopathy (DR) that currently has no approved treatment and can result in vision loss. The HORNBILL study (NCT04424290) is investigating BI-X in subjects with proliferative DR previously treated with panretinal photocoagulation and DMI.
Methods: In the completed single rising dose (SRD) part, DMI was defined using optical coherence tomography angiography (OCTA) as any disruption in retinal vascularity in the superficial and/or deep retinal plexus. Twelve subjects received 0.5 (n=3), 1.0 (n=3), or 2.5 mg (n=6) intravitreal BI-X. The primary SRD endpoint was the number of dose-limiting events. In the ongoing multiple-dosing (MD) part, DMI was defined using OCTA as a foveal avascular zone ≥0.5 mm2. Subjects in the MD part (planned N=30) are receiving three doses of 2.5 mg BI-X or sham injection over 8 weeks (with 16 weeks’ follow-up). The primary MD endpoint is the number of subjects with drug-related adverse events (AEs).
Results: In the SRD part no dose-limiting events or drug-related AEs were reported. There were eight AEs: five ocular and procedure related; two ocular but not procedure related; one neither ocular nor procedure related. The SRD part identified preliminary signs of efficacy: best corrected visual acuity improved by 5.3 (1.0 mg) and 4.0 letters (2.5 mg). To date, 29 subjects have been enrolled into the MD part. Recruitment is now complete.
Conclusions: Single doses of BI-Xwere well tolerated and showed signs of efficacy. The MD part is further evaluating the safety and efficacy of BI-X in subjects with DMI.