A Study of BI 765128 in Patients With an Eye Condition Called Diabetic Macular Ischemia Who Have Received Laser Treatment
NCT ID: NCT04919499
Last Updated: 2024-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
46 participants
INTERVENTIONAL
2021-07-30
2023-08-07
Brief Summary
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In this study, BI 765128 is given to people for the first time.
The study has 2 parts. Part A tests 3 doses of BI 765128. Participants get either a low, medium or high dose of BI 765128 as a single injection into the eye. If participants tolerate it well, the highest dose will be used in part B.
In part B, participants are put into 2 groups randomly, which means by chance. 1 group gets BI 765128 as injection into the eye. The other group gets sham injections. 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. In this part, participants receive study treatment once every month for 3 months.
Participants in part A are in the study for about 4 months and visit the study site about 8 times.
Participants in part B are in the study for about 5 months and visit the study site about 7 times.
The doctors regularly check participants' health and take note of any unwanted effects.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
In Part A no masking will be performed. In Part B participant and investigator will be masked.
Description to randomisation:
In Part A no randomisation will be performed. In Part B randomisation will be performed.
Study Groups
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Single rising dose part: low-dose BI 765128
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of low-dose BI 765128.
BI 765128
BI 765128
Single rising dose part: medium-dose BI 765128
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of medium-dose BI 765128.
BI 765128
BI 765128
Single rising dose part: high-dose BI 765128
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of high-dose BI 765128.
BI 765128
BI 765128
Multiple dose part: high-dose BI 765128
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received 3 single intravitreal injection of high-dose BI 765128 at week 1, 4 and 8.
BI 765128
BI 765128
Multiple dose part: Sham
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received 3 single intravitreal sham injection at week 1, 4 and 8.
Sham comparator
Sham comparator
Interventions
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BI 765128
BI 765128
Sham comparator
Sham comparator
Eligibility Criteria
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Inclusion Criteria
* Panretinal photocoagulation-treated diabetic retinopathy (DR) patients with either no or inactive retinal neovascularization per investigator judgement in the study eye
* Male or female subjects of age ≥ 18 years
* Evidence of diabetic macular ischemia (DMI) per investigator´s judgement, defined as any degree of disruption of retinal vascularity in optical coherent tomography angiography (OCTA)
* Glycosylated Hemoglobin, Type A1C (HbA1c) of ≤ 12.0%
* Best-corrected visual acuity (VA) ≤75 letters (20/32) in the study eye
* Best corrected visual acuity (VA) in the non-study eye must be equal to or better than best corrected VA in the study eye. If both eyes are eligible and have identical best corrected 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 method 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.
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Part B:
* Panretinal photocoagulation-treated diabetic retinopathy (DR) patients with either no or inactive retinal neovascularization per investigator judgement
* Male or female subjects of age ≥ 18 years
* Presence of significant diabetic macular ischemia (DMI): Large foveal avascular zone (FAZ) defined as those with ≥0.5mm2 area present on optical coherent tomography angiography (OCTA). If FAZ is \<0.5mm2 then an enlarged peri-foveal inter-capillary space in at least 1 quadrant will be sufficient.
* Glycosylated Hemoglobin, Type A1C (HbA1c) of ≤ 12.0%
* Best-corrected visual acuity (VA) ≤85 letters (20/20) in the study eye
* If both eyes are eligible, the investigator may select either eye to be 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 method 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.
* Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
Exclusion Criteria
* Subjects receiving intravitreal (IVT) injections for active Diabetic Macular Edema (DME) (anti-vascular endothelial growth factor (VEGF), steroids) and macular laser in the previous 3 months to screening in the study eye
* Subjects receiving anti-VEGF IVT injections for active diabetic retinopathy (DR) in the previous 3 months to screening in the study eye
* Current or planned use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoxamine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol)
* Additional progressive eye disease in the study eye that could compromise best corrected visual acuity (VA) (best corrected visual acuity (BCVA)), uncontrolled glaucoma (intra-ocular pressure (IOP)\>24), 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 spectral domain optical coherence tomography (SD-OCT) and optical coherent tomography angiography (OCTA).
* Any intraocular surgery in the study eye within 3 months prior to screening
* Glaucoma tube shunts
* Aphakia or total absence of the posterior capsule. Yttrium aluminum garnet (YAG) laser capsulotomy permitted, if completed more than 3 months prior to screening, in the study eye
Part B:
* Diabetic Macular Edema (DME), defined as a Central Subfield Thickness (CST) ≥ 305μm for men and ≥ 290 μm for women (Optovue Angiovue) in the study eye
* Subjects receiving intravitreal (IVT) injections for active DME (anti-vascular endothelial growth factor (VEGF), steroids) and macular laser in the previous 3 months to screening in the study eye
* Subjects receiving anti-VEGF intravitreal IVT injections for active Diabetic Retinopathy (DR) in the previous 3 months to screening in the study eye
* Heavily lasered macula in the study eye per investigator judgement
* History of vitrectomy in the study eye
* Epiretinal membrane with extended foveal contour distortion in the study eye
* Current or planned use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoxamine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol)
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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California Retina Consultants
Bakersfield, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
Bay Area Retina Associates - Walnut Creek
Walnut Creek, California, United States
Cumberland Valley Retina Consultants, PC.
Hagerstown, Maryland, United States
Meridian Clinical Research, LLC
Cincinnati, Ohio, United States
Erie Retina Research, LLC
Erie, Pennsylvania, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, United States
Austin Research Center for Retina, PLLC
Austin, Texas, United States
Austin Clinical Research, LLC
Austin, Texas, United States
Retina Consultants of Texas
Bellaire, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
Adelaide Eye and Retina Centre
Adelaide, South Australia, Australia
Hobart Eye Surgeons
Hobart, Tasmania, Australia
Riga East University Hospital
Riga, , Latvia
Leids Universitair Medisch Centrum (LUMC)
Leiden, , Netherlands
Hospital Dos de Maig
Barcelona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
Bristol Eye Hospital
Bristol, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Moorfields Eye Hospital
London, , United Kingdom
Central Middlesex Hospital
London, , United Kingdom
Oxford Eye Hospital
Oxford, , United Kingdom
Sunderland Eye Infirmary
Sunderland, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2020-005425-87
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1451-0001
Identifier Type: -
Identifier Source: org_study_id
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