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

(PARTRIDGE Trial)

Recruiting at 36 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Boehringer Ingelheim

Must not be taking: Anti-VEGF, Steroids, Retinal-toxics

Disqualifiers: Uncontrolled glaucoma, High myopia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

46 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications known to be toxic to the eye, like chloroquine or tamoxifen. If you are receiving certain eye treatments, like anti-VEGF injections, you must not have had them in the last 3 months before the trial.

Eligibility Criteria

Inclusion Criteria

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%

Exclusion Criteria

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

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)

You have glaucoma and have had a tube shunt surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Rising Dose Part

Participants receive a single intravitreal injection of low, medium, or high dose of BI 765128

4 months

8 visits (in-person)

Multiple Dose Part

Participants receive monthly intravitreal injections of high-dose BI 765128 or sham injections for 3 months

5 months

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BI 765128
• Sham comparator

Participant Groups

Group I: Single rising dose part: medium-dose BI 765128 Experimental Treatment 1 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 765128 Experimental Treatment 1 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 765128 Experimental Treatment 1 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 765128 Experimental Treatment 1 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: Sham Placebo Group 1 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.

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+