A Study of BI 765128 in Patients With an Eye Condition Called Diabetic Macular Ischemia Who Have Received Laser Treatment

Diabetic Retinopathy Clinical Trial

— PARTRIDGE  

Official title:

A First in Human Trial to Study Safety and Tolerability of Single Rising Intravitreal Doses (oPen Label, Non-randomized, Uncontrolled) and in Addition the Early Biological Response of mulTiple Intravitreal Doses (Double-masked, RandomIzed, Sham-controlleD) of BI 765128 in Panretinal photocoaGulation (PRP) Treated Diabetic rEtinopathy (DR) Patients With Diabetic Macular Ischemia (DMI) - the PARTRIDGE Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04919499
• Other study ID #: 1451-0001
• Secondary ID: 2020-005425-87
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 30, 2021
• Est. completion date: August 7, 2023

Study information

• Verified date: September 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is open to adults with diabetic macular ischemia who have received laser treatment. The main purpose of this study is to find out whether people with diabetic macular ischemia can tolerate a medicine called BI 765128.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 7, 2023
• Est. primary completion date: August 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Part A

• 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:

Part A:

• 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

• Subjects 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 subject an unreliable trial subject) Further exclusion criteria apply

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)

• Additional eye disease in the study eye that could compromise best corrected VA (BCVA). Significant visual field loss, uncontrolled glaucoma (IOP>24), clinically significant diabetic maculopathy, 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 and OCTA Further exclusion criteria apply

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Ischemia
• Retinal Diseases

Intervention

Drug:
• BI 765128
BI 765128

Other:
• Sham comparator
Sham comparator

Locations

Country	Name	City	State
Australia	Adelaide Eye and Retina Centre	Adelaide	South Australia
Australia	Hobart Eye Surgeons	Hobart	Tasmania
Latvia	Riga East University Hospital	Riga
Netherlands	Leids Universitair Medisch Centrum (LUMC)	Leiden
Spain	Hospital Dos de Maig	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Miguel Servet	Zaragoza
United Kingdom	Bristol Eye Hospital	Bristol
United Kingdom	Royal Liverpool University Hospital	Liverpool
United Kingdom	Central Middlesex Hospital	London
United Kingdom	Moorfields Eye Hospital	London
United Kingdom	Oxford Eye Hospital	Oxford
United Kingdom	Sunderland Eye Infirmary	Sunderland
United States	Austin Clinical Research, LLC	Austin	Texas
United States	Austin Research Center for Retina, PLLC	Austin	Texas
United States	California Retina Consultants	Bakersfield	California
United States	Retina Consultants of Texas	Bellaire	Texas
United States	Meridian Clinical Research, LLC	Cincinnati	Ohio
United States	Erie Retina Research, LLC	Erie	Pennsylvania
United States	Cumberland Valley Retina Consultants, PC.	Hagerstown	Maryland
United States	Mid Atlantic Retina	Philadelphia	Pennsylvania
United States	Retinal Consultants Medical Group	Sacramento	California
United States	Retina Consultants of Texas	The Woodlands	Texas
United States	Bay Area Retina Associates - Walnut Creek	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Latvia,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Number of subjects with ocular dose limiting events (DLEs) from drug administration until day 8 (7 days after treatment)		up to 7 days
Primary	Part B: Number of subjects with drug related Adverse Events (AEs) from drug administration until end of study (EOS)		up to 20 weeks
Secondary	Part A: Number of subjects with drug related Adverse Events (AEs) at end of study (EOS)		up to 14 weeks
Secondary	Part A: Number of subjects with any ocular Adverse Events (AEs) (eye disorders) at end of study (EOS)		up to 14 weeks
Secondary	Part B: Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) at visit 5		up to 12 weeks
Secondary	Part B: Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) at visit 6		up to 16 weeks
Secondary	Part B: Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) at visit 7		up to 20 weeks
Secondary	Part B: Change from baseline of best corrected visual acuity (BCVA) at Visit 7		up to 20 weeks
Secondary	Part B: Number of subjects with any ocular Adverse Events (AEs) (eye disorders) from drug administration until end of study (EOS)		up to 20 weeks

External Links

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