Safety and Effect on Central Retinal Thickness of BI 1026706 in Patients With Diabetic Macular Edema

Phase 2

Completed

• Conditions: Macular Edema
• Interventions: Drug: BI 1026706; Drug: Placebo

• Registration Number: NCT02732951
• Lead Sponsor: Boehringer Ingelheim

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-05
• Study First Posted: 2016-04-11
• Study Start: 2016-04-14
• Primary Completion: 2017-10-23
• Study Completion: 2017-10-24
• Results First Submitted: 2018-10-04
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-18
• Last Update Submitted: 2019-03-18
• Results First Posted: 2019-03-20
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 1026706	BI 1026706	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Central Subfield Foveal Thickness (CSFT) at Week 12	Baseline and Week 12	The change from baseline in CSFT at Week 12 and the BI 1026706 effect was compared between the BI 1026706 treatment group and the placebo group as measured by Spectral-domain Optical Coherence Tomography (SD-OCT). Baseline was defined as the CSFT value measured at the visit when patients were randomised. Mean presented here is an adjusted mean.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Serious Adverse Events (SAEs), Investigator Defined Drug-related Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)	From first drug administration until 4 days after last drug administration, up to 89 days.	Number of subjects with serious adverse events (SAEs), Investigator defined drug-related Adverse events (AEs) and adverse events of special interest (AESIs) comparing the BI 1026706 treatment group with the placebo group is presented.

Trial Locations

Locations (35)

Brussels-UNIV Brugmann -Horta; 🇧🇪 Brussel, Belgium

Leuven - UNIV UZ Leuven (Sint-Rafaël); 🇧🇪 Leuven, Belgium

HOP Nord; 🇫🇷 Marseille, France

HOP Hôtel-Dieu; 🇫🇷 Nantes, France

HOP Lariboisière; 🇫🇷 Paris, France

Hosp National 15-20, Ophtalmo, Paris; 🇫🇷 Paris, France

HOP Pierre Paul Riquet; 🇫🇷 Toulouse, France

Universitätsklinikum Aachen, AöR; 🇩🇪 Aachen, Germany

Augen Zentrum Nordwest, Ahaus; 🇩🇪 Ahaus, Germany

Kamppeter Augenzentrum, Bayreuth; 🇩🇪 Bayreuth, Germany

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