CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 79 enrolled
Drug / intervention
BI 1467335 +1 moredrug
Likely dose
BI 1467335 once dailyAI-extracted
Key inclusion· 6
  • ✓Diagnosis of type 1 or type 2 diabetes mellitus documented by ADA and/or WHO criteria
  • ✓HbA1c ≤12% at screening
  • ✓Non-proliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) at DRSS level 47 or 53 in the study eye
  • ✓Best corrected visual acuity ETDRS letter score ≥70 letters in study eye
Key exclusion· 12
  • ✕Active center-involved DME (CI-DME) or OCT central subfield thickness >300 μm (Optovue) or >320 μm (Heidelberg)
  • ✕Evidence of neovascularization including active neovascularization of iris or angle (ruled out by gonioscopy within 4 weeks)
  • ✕Prior pan-retinal photocoagulation (≥100 burns outside posterior pole)
  • ✕DME or DR treatment with macular laser within 3 months or intraocular injections within 6 months prior to screening; >4 prior intraocular injections at any time

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03238963
NCT03238963Phase 2Completed
CompareCT.gov

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)

Boehringer Ingelheim·interventional·Posted Aug 3, 2017·Updated Jun 4, 2021

In Brief

A Phase 2 clinical trial evaluating BI 1467335 and Placebo for Diabetic Retinopathy. Completed, enrolled 79 participants across 35 sites in 8 countries.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Retinopathy
CountriesAustria, Greece, Italy, Norway, Portugal, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedAug 3, 2017
Enrollment StartSep 19, 2017
Primary CompletionMay 14, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.9 years ago

Interventions

BI 1467335drug

Once daily

Placebodrug

Once daily