A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated

Conditions

• Diabetic Macular Edema

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Low dose BI 3812465 — BIOLOGICAL
  BI 3812465
• Medium dose BI 3812465 — BIOLOGICAL
  BI 3812465
• High dose BI 3812465 — BIOLOGICAL
  BI 3812465

Study Details

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.

Key Dates

Start date

May 14, 2026

Status verified

Jun 2026

Primary completion

Mar 23, 2027

Completion

Jul 6, 2027

Study Design

Enrollment

49 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Treatment arm A
  Low dose of BI 3812465.
• Experimental: Part 1: Treatment arm B
  Medium dose of BI 3812465.
• Experimental: Part 1: Treatment arm C
  High dose BI 3812465.
• Experimental: Part 2: Treatment arm A
  Low dose BI 3812465.
• Experimental: Part 2: Treatment arm B
  Medium dose BI 3812465.
• Experimental: Part 2: Treatment arm C
  High dose BI 3812465.

Primary Outcome Measure

Part 1: Occurrence of dose limiting events (DLEs) from first investigational medicine product (IMP) administration until end of study (EOS) [ Time Frame: Up to 169 days. ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (30)

Find similar trials in Phoenix, AZ

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