Trial Search Results

HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia

This is a study in people with a type of diabetic eye disease called diabetic retinopathy with diabetic macular ischemia. People who have had laser treatment for their diabetic retinopathy can participate in the study. The laser treatment is called panretinal photocoagulation.

The purpose of the study is to find out how well different doses of a medicine called BI 764524 are tolerated. BI 764524 is injected into the eye. The study has 2 parts. In the first part, participants get different doses of BI 764524 only once. Participants are in the first part for about 5 months and visit the study site about 8 times. In the second part, participants are put into different groups by chance. Some participants get BI 764524 injections every 4 weeks. Other participants get sham injections every 4 weeks. A sham injection means that it is not a real injection and contains no medicine. Participants cannot tell whether they get the real injection or a sham injection. For the second part, participants are in the study for about 7 months. During this time, they visit the study site about 7 times. In this study, BI 764524 is given to humans for the first time.

The doctors compare how well people tolerate the BI 764524 injections and the sham injections.

The doctors also regularly check the general health of the participants.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Boehringer Ingelheim

Stanford Investigator(s):

Intervention(s):

  • Drug: BI 764524

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

Single rising dose (SRD) and multiple dosing (MD) part:

   - Pan-retinal photo coagulation treated proliferative diabetic retinopathy (PDR)
   participants with either no or inactive retinal neovascularization per investigator
   judgement in the study eye

   - Male or female participants of age ≥ 18 years

   - HbA1c of ≤ 12.0%

   - Best-corrected Visual activity (VA) in the non-study eye better than best-corrected VA
   in the study-eye, if both eyes are eligible and have identical VA the investigator may
   select the study eye.

   - Women of childbearing potential (WOCBP) and men able to father a child must be ready
   and able to use two methods of contraception with at least one of them being a highly
   effective methods of birth control per ICH M3 (R2) that result in a low failure rate
   of less than 1% per year when used consistently and correctly. A list of contraception
   methods meeting these criteria is provided in the patient information and in the
   clinical trial protocol.

   --A woman is considered of childbearing potential (WOCBP), i.e. fertile, following
   menarche and until becoming postmenopausal unless permanently sterile. Permanent
   sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral
   oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A
   postmenopausal state is defined as no menses for 2 years without an alternative
   medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal
   range may be used to confirm a post-menopausal state in women not using hormonal
   contraception or hormonal replacement therapy. However in the absence of 2 years of
   menorrhea, a single FSH measurement is sufficient.

   - Signed and dated written informed consent in accordance with ICH Harmonized Guideline
   for Good Clinical Practice (ICH GCP) and local legislation prior to admission to the
   trial

SRD part only:

   - Evidence of diabetic macular ischemia (DMI) per investigator´s judgement, defined as
   any degree of disruption of retinal vascularity in superficial and/or deep retinal
   plexus in OCTA

   - Best-corrected VA ≤55 letters (20/80) or worse

MD part only:

   - Presence of significant DMI: large foveal avascular zone defined as those with ≥0.5mm2
   area in superficial vascular complex (SVC) present on optical coherence tomography
   angiography. If FAZ is <0.5mm2 then enlarged peri-foveal inter-capillary space in at
   least 1 quadrant will be sufficient.

   - Best-corrected VA ≤ 85 letters (20/20) or worse

Exclusion Criteria:

SRD part only:

   - Participants receiving intravitreal (IVT) injections for active diabetic macular edema
   (DME, injections: anti-vascular endothelial growth factor (VEGF), steroids) and
   macular laser in the study eye in the previous 3 months prior to enrolment

   - Participants receiving anti-VEGF IVT injections for active PDR in the study eye in the
   previous 3 months prior to enrolment

   - Current or planned use of medications known to be toxic to the retina, lens or optic
   nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine,
   phenothiazines, tamoxifen, nicotinic acid, and ethambutol)

   - Additional eye disease in the study eye that could compromise best corrected VA (BCVA)
   with visual field loss, uncontrolled glaucoma (IOP>24), age related macular
   degeneration, history of ischemic optic neuropathy or retinal vascular occlusion,
   symptomatic vitreomacular traction, or genetic disorders such as retinitis pigmentosa;
   history of high myopia > 8 diopters in the study eye. Anterior segment and vitreous
   abnormalities in the study eye that would preclude adequate observation with SD-OCT

   - Any intraocular surgery in the study eye within 3 months prior to screening

   - Aphakia or total absence of the posterior capsule. Yttrium aluminium garnet (YAG)
   laser capsulotomy in the study eye if performed less than 3 months prior to enrolment

   - Participants not expected to comply with the protocol requirements or not expected to
   complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other
   condition that, in the investigator´s opinion, makes the patient an unreliable trial
   participant)

   - Previous participation in this trial or in other trials with IVT injections
   administered within 3 months.

Further exclusion criteria apply.

MD part only:

   - DME, defined as a central subfield thickness (CST) ≥305 micrometer (μm) for men and
   ≥290 μm women measured with optovue (Optical coherent tomography) OCT in the study eye

   - Participants receiving IVT injections for active DME (anti-VEGF, steroids) and macular
   laser in the study eye in the previous 3 months prior to enrolment

   - Participants receiving anti-VEGF IVT injections for active PDR in the study eye in the
   previous 3 months prior to enrolment

   - Heavily lasered macula in the study eye per investigator's judgement

   - History of vitrectomy in the study eye

   - Epiretinal membrane with extended foveal contour distortion in the study eye per
   investigator's judgement

   - Clinically significant disorganisation of retinal inner layer (DRIL) in the study eye

   - Current or planned use of medications known to be toxic to the retina, lens or optic
   nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine,
   phenothiazines, tamoxifen, nicotinic acid, and ethambutol) Further exclusion criteria
   apply.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Quan Nguyen
+001 (650) 724-4280
Recruiting