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Monoclonal Antibodies
A Study of BI 765128 in Patients With an Eye Condition Called Diabetic Macular Ischemia Who Have Received Laser Treatment (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. change from baseline values at day 141±7 (visit 7) is reported.
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 weeks3 visits
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. change from baseline values at day 113±7 (visit 6) is reported.
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. change from baseline values at day 113±7 (visit 6) is reported.
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 moreSide effects data
From 2023 Phase 1 & 2 trial • 46 Patients • NCT0491949910%
Lipase increased
10%
Urine ketone body present
10%
Vitreous floaters
10%
Asthenia
10%
Blood urine present
10%
Chest pain
10%
Vitreous haemorrhage
10%
Glucose urine present
10%
Glycosylated haemoglobin increased
10%
Heart rate increased
10%
Headache
10%
Cough
10%
Herpes zoster
10%
Blepharitis
10%
Iridocyclitis
10%
Blood pressure increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Multiple Dose Part: Sham
Single Rising Dose Part: Low-dose BI 765128
Single Rising Dose Part: High-dose BI 765128
Single Rising Dose Part: Medium-dose BI 765128
Multiple Dose Part: High-dose BI 765128
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
2,551 Previous Clinical Trials
15,857,979 Total Patients Enrolled
4 Trials studying Diabetic Retinopathy
362 Patients Enrolled for Diabetic Retinopathy