*1451-0001 PARTRIDGE Study
Research type
Research Study
Full 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, shamcontrolleD) of BI 765128 in panretinal photocoaGulation (PRP) treated diabetic rEtinopathy (DR) patients with diabetic macular ischemia (DMI) - the PARTRIDGE Study
IRAS ID
296939
Contact name
Sobha Sivaprasad
Contact email
Sponsor organisation
Boehringer Ingelheim
Eudract number
2020-005425-87
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 21 days
Research summary
Research Summary - This trial will investigate ocular (eye) and systemic (whole body) safety and tolerability using the active trial drug BI 765128, which will be administered to treat Diabetic Macular Ischaemia (DMI) for which no approved treatment currently exists.
DMI is a condition that can have significant impact on vision. Low oxygen levels caused by DMI may damage the retina (light-sensitive layer at the back of the eye where images are formed). SEMA3A is a substance produced by cells in the eye when oxygen levels are low, this stops blood vessels in the eye from resupplying the retinal tissue with blood and nutrients. BI 765128 stops SEMA3A binding to cells in the retina. This means the blood supply returns to the damaged retinal tissue, thereby improving DMI.
The study will recruit people affected by DMI with visual loss and is planned to investigate up to 3 rising doses (3-6 Participants per dose group) of BI 765128. BI 765128 will be injected inside one eye. The trial will start with the first dose group and continue with assigning further Participants to the next higher dose group, if the first dose was found safe, and so on, until the planned number of up to 18 Participants have entered the trial. Doses will only be increased if there are no problems concerning safety and tolerability noted. Each Participant will be included in only one single dose group and will receive one injection in total.
The trial will be conducted in two parts; Part A (Single Rising Dose) and Part B (Multiple Dosing) with 13 Participants planned in the UK (Part A + Part B)
Part A will last approximately 18 weeks with 8 visits to the trial site
Part B will last approximately 24 weeks with 7 or 8 visits to the trial site.
Lay Summary - A study of BI 765128 in participants with an eye condition called diabetic macular ischemia who have received laser treatment (PARTRIDGE) This is a summary of results from 1 clinical study.
We thank all study participants. You helped us to answer important questions about BI 765128 and the treatment of diabetic macular ischaemia.What was this study about?
The purpose of this study was to find out if participants could tolerate different doses of a study medicine called BI 765128. All participants had diabetic macular ischemia (DMI) and had received laser treatment for diabetic retinopathy (DR).
- DR affects the tiny blood vessels inside the retina. This can lead to vision impairment or blindness.
- DMI is a complication of DR where the blood leaked in the retina. This can lead to worsening of vision and can cause permanent vision loss.
Another purpose of this study was to find the highest dose of BI 765128 for further studies. This was the first time that BI 765128 was given to people.
At the time of this study, there was no approved treatment to prevent DMI or to stop DMI from getting worse in people with laser treated DR. BI 765128 is being developed as a potential treatment for DMI.Who took part in this study?
Adults 18 years of age or older could take part in this study if they previously had laser treatment for DR with DMI.
This study had 2 parts. Participants could only join one part of the study:
- Part 1 had 12 participants. There were 7 men and 5 women. The youngest participant was 40 years old, and the oldest participant was 78 years old. The average age was 62 years.
- Part 2 had 33 participants. There were 20 men and 13 women. The youngest participant was 23 years old, and the oldest participant was 73 years old. The average age was 56 years.
120 people took part in this study. The youngest participant was 46 years old, and the oldest participant was 89 years old. The average age was 70 years old.How was this study done?
Part 1:
This part of the study tested 3 different doses of BI 765128. The first participants who started the study received a low dose. Participants who started the study later received higher doses of BI 765128 if the lower doses were well tolerated. On Day 1 of the study, participants received a single dose of BI 765128 as 1 injection into 1 eye, also called the study eye. The participants were divided into 3 groups. The groups were:
- Low-dose group: Participants received a low dose of BI 765128 as an injection.
- Medium-dose group: Participants received a medium dose of BI 765128 as an injection.
- High-dose group: Participants received a high dose of BI 765128 as an injection.
The participants and doctors knew which dose each participant was receiving.
Part 1 had to finish first before Part 2 started. If participants in Part 1 could tolerate the high dose of BI 765128, then this dose was chosen to be given to participants in Part 2.
Part 2:
This part of the study compared BI 765128 with sham injections.
A sham injection mimics and feels like a real eye injection, but it does not penetrate the eye. Sham did not contain any medicine. We compared BI 765128 with sham to find out how well BI 765128 works.
Participants were divided into 2 groups randomly. For every 2 participants who were assigned to the BI 765128 group, 1 participant was assigned to the sham group. No one could choose which group a participant was placed in, because it was done by a computer. The groups were:
- BI 765128 group: Participants received 3 injections of a high dose of BI 765128. They got each injection separately into the study eye every 4 weeks for 3 months.
- Sham group: Participants received 3 sham injections. They got each sham injection separately on the study eye every 4 weeks for 3 months.
In this part of the study, only the person giving the injection at the study site knew which treatment participants received. The person giving the injection was not involved in any other aspect of the study. The participants and doctors did not know which treatment the participants received. This is because knowing which treatment a participant gets might affect the results of the study. At the end of the study, researchers learned which treatment each participant received.
In this study, we wanted to find out if participants could tolerate different doses of BI 765128. We also wanted to find the highest dose of BI 765128 for further studies. To find out, we looked at the following results of participants:
- Part 1: The number of participants with a dose-limiting event (DLE) A DLE is when participants have certain severe health problems in the study eye that happened within 7 days of treatment with BI 765128. A DLE would limit any further increase in the dose.
- Part 1 and Part 2: The number of participants with unwanted effects Unwanted effects are health problems that the doctors think may be caused by the study medicine.
After treatment with BI 765128, participants had follow-up visits. Participants visited the doctors regularly. During these visits, the doctors collected information about participants’ health.
Participants in Part 1 were in the study for about 4 months. Participants in Part 2 were in the study for up to about 6 months.What were the results of this study?
All tested doses of BI 765128 were well tolerated by the participants.
After reviewing the study data, a scientific committee decided that the high dose should be used for further studies with BI 765128.
In Part 1:
No participant had a DLE within 7 days of treatment with BI 765128.
No participant had unwanted effects during the study.
In Part 2:
1 out of 23 participants (4%) in the BI 765128 group had an unwanted effect. This unwanted effect was build-up of fluid in a part of the eye called macula (macula oedema).
No participants in the sham group had unwanted effects.
None of the unwanted effects were serious. This means that the unwanted effects did not lead to a hospital stay, that they were not life-threatening, and that they did not lead to a disability.Where did the study take place?
The following listing shows the regions and countries with the number of treated participants:
Europe (19): Latvia (3), Netherlands (1), Spain (3), and United Kingdom (12) North America (24): United States (24) Australia (2): Australia (2) The total number of participants in the European Union was 7.Is there more information about this study?
You can find further information about this study at these websites:
1. Go to https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.mystudywindow.com%2F&data=05%7C02%7Cbrightonandsussex.rec%40hra.nhs.uk%7C3683225ee9404a0e016708dcc03f324a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638596624861436353%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=KAocbTpYSYt6YJWgbzfjASvCriTjuRo28vGZWBgOIs8%3D&reserved=0 and search for the study number 1451-0001.
2. Go to https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrialsregister.eu%2Fctr-search&data=05%7C02%7Cbrightonandsussex.rec%40hra.nhs.uk%7C3683225ee9404a0e016708dcc03f324a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638596624861453264%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=EoKsStnqsOshDpeuNqbTCJQ69GvMXRDPw4x%2FK8C%2F7Bk%3D&reserved=0 and search for the EudraCT number 2020-005425-87.
3. Go to https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C02%7Cbrightonandsussex.rec%40hra.nhs.uk%7C3683225ee9404a0e016708dcc03f324a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638596624861469140%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=vgsAA9kTVJBXz8gEEMscr2ImIR106DAqtjkXW1HiKd4%3D&reserved=0 and search for the NCT number NCT04919499.
Boehringer Ingelheim sponsored this study. For contact details, please visit https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.boehringer-ingelheim.com%2Fcontact-us&data=05%7C02%7Cbrightonandsussex.rec%40hra.nhs.uk%7C3683225ee9404a0e016708dcc03f324a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638596624861481751%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=j2eA%2FlR%2BKUmdsakXI0An6223FNc8Q%2BMbcW7ItMwqJbM%3D&reserved=0.
The full title of the study is: 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 This was a Phase 1/2a study. This study started in October 2021 and finished in August 2023.Are there additional studies?
If we do more clinical studies with BI 765128, you will find them on the websites listed above. To search for these studies, use the word BI 765128.Important notice
This lay summary is provided as part of Boehringer Ingelheim’s commitment to publicly share clinical study results.
This summary shows only the results from one study and may not represent all of the knowledge about the medicine studied. Other studies may have different results. Usually, more than one study is carried out to find out how well a medicine works and to determine the side effects of a medicine.
This lay summary may include uses, formulations, or treatment regimens for the medicine studied that may be approved or not approved in your country. This lay summary is not intended to promote any product or indication, to guide treatment decisions, or to replace the advice of a healthcare professional.
You should not change your therapy based on the results of this study. Always consult with your treating physician about your therapy.
©2024 Boehringer Ingelheim International GmbH
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: Results were submitted on 02-Aug-24 but are still unavailable on:https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.mystudywindow.com%2F&data=05%7C02%7Cbrightonandsussex.rec%40hra.nhs.uk%7C3683225ee9404a0e016708dcc03f324a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638596624861491948%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=VqXo1MO64PTlrhPrpMJUEig%2BKDkelW8SM8okMGAREqw%3D&reserved=0; study number 1451-0001
https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrialsregister.eu%2Fctr-search&data=05%7C02%7Cbrightonandsussex.rec%40hra.nhs.uk%7C3683225ee9404a0e016708dcc03f324a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638596624861499907%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=gSBGYrfU%2FLvsN8dEgxE3lvfmKPx%2BPFLJSPtPWvX7nu4%3D&reserved=0; EudraCT number
2020-005425-87https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.clinicaltrials.gov%2F&data=05%7C02%7Cbrightonandsussex.rec%40hra.nhs.uk%7C3683225ee9404a0e016708dcc03f324a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638596624861508814%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=GR946QCUs1ha9v5aOKsodS3WoS%2BxtWVqdP5waSEeo%2B4%3D&reserved=0; NCT number NCT04919499
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Pending
If yes, describe or provide URLs to disseminated materials:
If pending, date when dissemination is expected: 30/09/2024
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Yes
If yes, describe and/or provide URLs to materials shared and how they were shared: The lay summary in friendly format have been provided to trial investigators with the instruction to provide the results to the trial participants
If pending, date when feedback is expected:
If no, explain why they haven't:
Have you enabled sharing of study data with others?: Yes
If yes, describe or provide URLs to how it has been shared: Researchers are invited to use the external secured platform, Vivli (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fvivli.org%2Fmembers%2Fourmembers%2F&data=05%7C02%7Cbrightonandsussex.rec%40hra.nhs.uk%7C3683225ee9404a0e016708dcc03f324a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638596624861515419%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=2c6UCpvomEp85K3iO5ytRUK%2FF%2B0Uut2PwetOxE7XrY8%3D&reserved=0), to request access to anonymized data from our clinical studies.
If no, explain why sharing hasn't been enabled:
Have you enabled sharing of tissue samples and associated data with others?: Yes
If yes, describe or provide a URL: The data generated by analyses of tissue samples obtained during the trial can be shared following the process described in the previous question.
Residual samples collected and analysed during the trial are destroyed after the study end and the clinical study report is finalised as described in the consent form.
If no, explain why:REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
21/FT/0053
Date of REC Opinion
27 May 2021
REC opinion
Further Information Favourable Opinion