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

Sponsor

Boehringer Ingelheim (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04919499

Collaborator

(none)

Enrollment

Locations

Arms

22.2

Anticipated Duration (Months)

2.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Retinopathy	Drug: BI 765128 Other: Sham comparator	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Description to masking: 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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 30, 2021

Anticipated Primary Completion Date :

Jun 5, 2023

Anticipated Study Completion Date :

Jun 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A: BI 765128 low dose	Drug: BI 765128 BI 765128
Experimental: Part A: BI 765128 medium dose	Drug: BI 765128 BI 765128
Experimental: Part A: BI 765128 high dose	Drug: BI 765128 BI 765128
Experimental: Part B: BI 765128 Highest safe dose from Part A	Drug: BI 765128 BI 765128
Sham Comparator: Part B: Sham comparator	Other: Sham comparator Sham comparator

Outcome Measures

Primary Outcome Measures

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]
Part B: Number of subjects with drug related Adverse Events (AEs) from drug administration until end of study (EOS) [up to 20 weeks]

Secondary Outcome Measures

Part A: Number of subjects with drug related Adverse Events (AEs) at end of study (EOS) [up to 14 weeks]
Part A: Number of subjects with any ocular Adverse Events (AEs) (eye disorders) at end of study (EOS) [up to 14 weeks]
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]
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]
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]
Part B: Change from baseline of best corrected visual acuity (BCVA) at Visit 7 [up to 20 weeks]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Trinity Research	Dothan	Alabama	United States	36301
2	University of California Irvine	Irvine	California	United States	92697
3	Stanford University Medical Center	Palo Alto	California	United States	94303
4	University of California Los Angeles	Pasadena	California	United States	91105
5	Retinal Consultants Medical Group	Sacramento	California	United States	95825
6	Bay Area Retina Associates - Walnut Creek	Walnut Creek	California	United States	94598
7	Elman Retina Group, P.A.	Baltimore	Maryland	United States	21237
8	Meridian Clinical Research, LLC	Cincinnati	Ohio	United States	45219
9	Mid Atlantic Retina	Philadelphia	Pennsylvania	United States	19107
10	Austin Research Center for Retina, PLLC	Austin	Texas	United States	78705
11	Austin Clinical Research, LLC	Austin	Texas	United States	78750
12	Retina Consultants of Texas	Bellaire	Texas	United States	77401
13	Valley Retina Institute, PA	McAllen	Texas	United States	78503
14	Retina Consultants of Texas	The Woodlands	Texas	United States	77384
15	Emerson Clinical Research Institute	Falls Church	Virginia	United States	22042
16	Hospital Clínico San Carlos	Madrid		Spain	28040
17	Bristol Eye Hospital	Bristol		United Kingdom	BS1 2LX
18	Royal Liverpool University Hospital	Liverpool		United Kingdom	L7 8XP
19	Moorfields Eye Hospital	London		United Kingdom	EC1V 2PD
20	Oxford Eye Hospital	Oxford		United Kingdom	OX3 9DU

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT04919499

Other Study ID Numbers:

1451-0001
2020-005425-87

First Posted:

Jun 9, 2021

Last Update Posted:

Aug 11, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Retinal Diseases

Diabetic Retinopathy

Ischemia

Study Results

No Results Posted as of Aug 11, 2022