CompletedPhase 2

A Study That Tests BI 1467335 in Patients With Diabetic Eye Disease (Diabetic Retinopathy). It Looks at the Way BI 1467335 is Taken up, the Effects it Has, and How Well it is Tolerated.

United States79 participantsStarted 2017-09-19

Plain-language summary

The main objective is to evaluate ocular and systemic safety and tolerability of BI 1467335 as well as whether BI 1467335 monotherapy has a potential to improve retinal lesions in patients with moderately severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 47) or severe Non-proliferative diabetic retinopathy (NPDR) (DRSS level 53), without Center-involved diabetic macular edema (CI-DME)

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓-Documented diabetes by American Diabetes Association (ADA) and/or World Health Organization criteria

What they're measuring

Percentage of Participants With Any Ocular Adverse Events Over the On-treatment Period

Timeframe: On-treatment period: from first dose of study drug until end of follow-up period, up to 24 weeks.

Trial details

NCT IDNCT03238963

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-05-14

Results submitted2021-05-11

View on ClinicalTrials.gov More Diabetic Retinopathy trials