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BI 3812465 for Diabetic Macular Edema

Not yet recruiting at 26 trial locations
BI
Overseen ByBoehringer Ingelheim
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Boehringer Ingelheim
Must not be taking: Corticosteroids
Disqualifiers: Proliferative diabetic retinopathy, uncontrolled glaucoma, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is open to adults with diabetic macular edema that involves the center of the eye. The purpose of this study is to find out how well different doses of a medicine called BI 3812465 are tolerated by people with this condition. This is the first time BI 3812465 is given to humans.

This study has 2 parts. In Part 1, a small number of participants receive low, medium, or high doses of BI 3812465. The first participants to start the study get low doses of BI 3812465. Participants who start later get higher doses only if the lower doses were tolerated. In Part 2, a larger number of participants are placed into low, medium, or high dose groups. Participants in both parts of the study get BI 3812465 as injections into the back of the eye for a total of 3 eye injections.

Participants are in the study for up to 7 months. During this time, they visit the study site 19 times. Where possible, some visits can be done at the participant's home instead of the study site. At study visits, the doctors check the severity of participants' eye condition and note any health problems that could have been caused by BI 3812465.

Are You a Good Fit for This Trial?

Inclusion Criteria

* Center-involved diabetic macular edema (CI-DME) defined as CST ≥320 μm (micrometers) at Screening, as confirmed on spectral-domain optical coherence tomography (SD-OCT) and confirmed by the central reading center (CRC).
* Sufficiently clear ocular media, adequate pupillary dilation, and fixation, to permit quality fundus imaging.
I have type 1 or type 2 diabetes that is treated and my HbA1c is below 12%.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive low, medium, or high doses of BI 3812465 as intravitreal injections

3 months
9 visits (in-person or at home)

Treatment Part 2

A larger number of participants receive low, medium, or high doses of BI 3812465 as intravitreal injections

3 months
10 visits (in-person or at home)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

  • BI 3812465

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Group I: Part 2: Treatment arm CExperimental Treatment1 Intervention
Group II: Part 2: Treatment arm BExperimental Treatment1 Intervention
Group III: Part 2: Treatment arm AExperimental Treatment1 Intervention
Group IV: Part 1: Treatment arm CExperimental Treatment1 Intervention
Group V: Part 1: Treatment arm BExperimental Treatment1 Intervention
Group VI: Part 1: Treatment arm AExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials
2,566
Recruited
16,150,000+

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