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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04919499
Recruitment Status : Recruiting
First Posted : June 9, 2021
Last Update Posted : June 16, 2022
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 30, 2021
Estimated Primary Completion Date : June 5, 2023
Estimated Study Completion Date : June 5, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Part A: Number of subjects with ocular dose limiting events (DLEs) from drug administration until day 8 (7 days after treatment) [ Time Frame: up to 7 days ]
  2. Part B: Number of subjects with drug related Adverse Events (AEs) from drug administration until end of study (EOS) [ Time Frame: up to 20 weeks ]

Secondary Outcome Measures :
  1. Part A: Number of subjects with drug related Adverse Events (AEs) at end of study (EOS) [ Time Frame: up to 14 weeks ]
  2. Part A: Number of subjects with any ocular Adverse Events (AEs) (eye disorders) at end of study (EOS) [ Time Frame: up to 14 weeks ]
  3. Part B: Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) at visit 5 [ Time Frame: up to 12 weeks ]
  4. Part B: Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) at visit 6 [ Time Frame: up to 16 weeks ]
  5. Part B: Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) at visit 7 [ Time Frame: up to 20 weeks ]
  6. Part B: Change from baseline of best corrected visual acuity (BCVA) at Visit 7 [ Time Frame: up to 20 weeks ]
  7. Part B: Number of subjects with any ocular Adverse Events (AEs) (eye disorders) from drug administration until end of study (EOS) [ Time Frame: up to 20 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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. desferoxamine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol) Further exclusion criteria apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04919499


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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United States, Alabama
Trinity Research Recruiting
Dothan, Alabama, United States, 36301
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
United States, California
Stanford University Medical Center Recruiting
Palo Alto, California, United States, 94303
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
Retinal Consultants Medical Group Recruiting
Sacramento, California, United States, 95825
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
Bay Area Retina Associates - Walnut Creek Recruiting
Walnut Creek, California, United States, 94598
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
United States, Maryland
Elman Retina Group, P.A. Recruiting
Baltimore, Maryland, United States, 21237
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
United States, Pennsylvania
Mid Atlantic Retina Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
United States, Texas
Austin Research Center for Retina, PLLC Recruiting
Austin, Texas, United States, 78705
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
Retina Consultants of Texas Recruiting
Bellaire, Texas, United States, 77401
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
Retina Consultants of Texas Recruiting
The Woodlands, Texas, United States, 77384
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
United Kingdom
Bristol Eye Hospital Recruiting
Bristol, United Kingdom, BS1 2LX
Contact: Boehringer Ingelheim    08000514022    unitedkingdom@bitrialsupport.com   
Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom, L7 8XP
Contact: Boehringer Ingelheim    08000514022    unitedkingdom@bitrialsupport.com   
Moorfields Eye Hospital Recruiting
London, United Kingdom, EC1V 2PD
Contact: Boehringer Ingelheim    08000514022    unitedkingdom@bitrialsupport.com   
Oxford Eye Hospital Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Boehringer Ingelheim    08000514022    unitedkingdom@bitrialsupport.com   
Sponsors and Collaborators
Boehringer Ingelheim
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT04919499    
Other Study ID Numbers: 1451-0001
2020-005425-87 ( EudraCT Number )
First Posted: June 9, 2021    Key Record Dates
Last Update Posted: June 16, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

  1. studies in products where Boehringer Ingelheim is not the license holder;
  2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
  3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Ischemia
Pathologic Processes
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases