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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.

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. mmrm values at day 113±7 (visit 6) are 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. 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

10%

Heart rate increased

10%

Lipase increased

10%

Headache

10%

Urine ketone body present

10%

Glucose urine present

10%

Vitreous floaters

10%

Vitreous haemorrhage

10%

Asthenia

10%

Blood urine present

10%

Chest pain

10%

Cough

10%

Glycosylated haemoglobin increased

10%

Herpes zoster

10%

Blepharitis

10%

Iridocyclitis

10%

Blood pressure increased

100%

80%

60%

40%

20%

Study treatment Arm

Multiple Dose Part: Sham

Single Rising Dose Part: High-dose BI 765128

Single Rising Dose Part: Low-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

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