CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 105 enrolled
Drug / intervention
BI 1026706 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 5
  • ✓Age 18 years or older
  • ✓Type 1 or type 2 diabetes mellitus
  • ✓Center-involved DME confirmed on SD-OCT with central subfield thickness ≥300 µm
  • ✓ETDRS letter score 70-84 in study eye
Key exclusion· 18
  • ✕Macular edema from causes other than DME
  • ✕Additional eye disease that might affect macular edema or visual acuity
  • ✕Anterior segment or vitreous abnormalities compromising visual acuity assessment or posterior pole examination
  • ✕Intraocular surgery in study eye within 4 months prior to randomization or planned during study

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

Search/NCT02732951
NCT02732951Phase 2Completed
CompareCT.gov

A Randomized, Double-masked, Placebo-controlled Exploratory Study to Evaluate Pharmacodynamics, Safety and Tolerability of Orally Administered BI 1026706 for 12 Weeks in Patients With Mild Visual Impairment Due to Center-involved Diabetic Macular Edema (DME)

Boehringer Ingelheim·interventional·Posted Apr 11, 2016·Updated Mar 20, 2019

In Brief

A Phase 2 clinical trial evaluating BI 1026706 and Placebo for Macular Edema. Completed, enrolled 105 participants across 35 sites in 8 countries.

Detailed Summary

This is a proof of mechanism trial to explore the effect of BI 1026706 on the central retinal thickness and to evaluate safety and tolerability of BI 1026706 administered orally for 12 weeks in patients with mild vision impairment due to center-involved DME

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMacular Edema
CountriesBelgium, France, Germany, Greece, Hungary, Portugal, Spain, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 11, 2016
Enrollment StartApr 14, 2016
Primary CompletionOct 23, 2017
Study CompletionOct 24, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 10.2 years ago

Interventions

BI 1026706drug

Placebodrug