← Back to Search

Monoclonal Antibodies

BI 765128 for Diabetic Retinopathy (PARTRIDGE Trial)

Phase 1 & 2
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up mmrm included measurements at baseline, day 29±3, day 57±3, day 85±7, day 113±7 and day 141±7. mmrm values at day 141±7 (visit 7) are reported.
Awards & highlights

Summary

This trial tests a new medicine called BI 765128 in adults with diabetic macular ischemia who have had laser treatment. The study aims to see if the medicine can be safely injected into the eye and tolerated by patients.

Eligible Conditions
  • Diabetic Retinopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~mmrm included measurements at baseline, day 29±3, day 57±3, day 85±7, day 113±7 and day 141±7. mmrm values at day 113±7 (visit 6) are reported.
This trial's timeline: 3 weeks for screening, Varies for treatment, and mmrm included measurements at baseline, day 29±3, day 57±3, day 85±7, day 113±7 and day 141±7. mmrm values at day 113±7 (visit 6) are reported. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Multiple Dose Part - Number of Subjects With Drug Related Adverse Events (AEs) From Drug Administration Until End of Study (EOS)
Single Rising Dose Part - Number of Subjects With Ocular Dose Limiting Events (DLEs) From Drug Administration Until Day 8 (7 Days After Treatment)
Secondary study objectives
Multiple Dose Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 7
Multiple Dose Part - Change From Baseline of the Size of the Foveal Avascular Zone (FAZ) in Optical Coherence Tomography Angiography (OCTA) at Visit 5
Multiple Dose Part - Change From Baseline of the Size of the Foveal Avascular Zone (FAZ) in Optical Coherence Tomography Angiography (OCTA) at Visit 6
+4 more

Side effects data

From 2023 Phase 1 & 2 trial • 46 Patients • NCT04919499
33%
Vision blurred
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Rising Dose Part: Medium-dose BI 765128
Single Rising Dose Part: High-dose BI 765128
Multiple Dose Part: High-dose BI 765128
Single Rising Dose Part: Low-dose BI 765128
Multiple Dose Part: Sham

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Single rising dose part: medium-dose BI 765128Experimental Treatment1 Intervention
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.
Group II: Single rising dose part: low-dose BI 765128Experimental Treatment1 Intervention
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.
Group III: Single rising dose part: high-dose BI 765128Experimental Treatment1 Intervention
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.
Group IV: Multiple dose part: high-dose BI 765128Experimental Treatment1 Intervention
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.
Group V: Multiple dose part: ShamPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 765128
2021
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,534 Previous Clinical Trials
11,357,481 Total Patients Enrolled
4 Trials studying Diabetic Retinopathy
362 Patients Enrolled for Diabetic Retinopathy
~11 spots leftby Sep 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top