NCT03238963

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.

A Randomized, Double-masked, Placebo-controlled Exploratory Study to Evaluate Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Orally Administered BI 1467335 for 12 Weeks With a 12 Week Follow up Period in Patients With Non-proliferative Diabetic Retinopathy Without Center-involved Diabetic Macular Edema (ROBIN Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	BI 1467335	Once daily
DRUG	Placebo	Once daily

Timeline

• Start date: 2017-09-19
• Primary completion: 2020-05-14
• Completion: 2020-05-14
• First posted: 2017-08-03
• Last updated: 2021-06-04
• Results posted: 2021-06-04

Locations

35 sites across 8 countries: United States, Austria, Greece, Italy, Norway, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study