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

Macular Edema Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732951
• Other study ID #: 1320.22
• Secondary ID: 2015-003529-33
• Status: Completed
• Phase: Phase 2
• Start date: April 14, 2016
• Est. completion date: October 24, 2017

Study information

• Verified date: March 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 24, 2017
• Est. primary completion date: October 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Patients 18 years of age and older

• Male patients or female patients of non-childbearing potential

• Diagnosis of Diabetes mellitus type 1 or type 2

• Retinal thickening due to Diabetic macular edema (DME) involving the center of the macula in the study eye as confirmed by the Investigator on clinical exam

• Center-involved DME confirmed on Spectral-Domain Optical Coherence Tomography (SD-OCT) with central subfield thickness (CSFT) of at least 300 µm in the study eye at screening, confirmed by Central Reading Centre

• Best corrected visual acuity ETDRS (Early Treatment Diabetic Retinopathy Study) letter score in the study eye of 84 or below, but at least 70 at screening

• Further inclusion criteria apply

Exclusion criteria:

• Macular edema considered to be due to other causes than DME in the study eye

• Additional eye disease in the study eye that, in the opinion of the Investigator, might affect macular edema or could compromise or alter visual acuity during the course of the trial

• Anterior segment and vitreous abnormalities in the study eye that would compromise the adequate assessment of the best corrected visual acuity or an adequate examination of the posterior pole

• Intraocular surgery in the study eye within 4 months prior to randomization or planned intraocular surgery, including cataract, during the study period

• Proliferative diabetic retinopathy or iris neovascularisation in the study eye

• Aphakia in the study eye

• Any indication that requires immediate treatment or for which treatment is expected in the study eye with anti-Vascular Endothelial Growth Factor (VEGF) or with laser photocoagulation during the period, as per Investigator's judgment

• History of prior laser photocoagulation or other surgical, intravitreal or peribulbar treatment in the study eye within 4 months prior to randomization, either for DME or an ocular condition other than DME

• History of fluocinolone acetonide intravitreal implant in the study eye

• Application of intraocular corticosteroids in the study eye within 2 years prior to randomization in phakic eyes or 9 months in pseudophakic eyes

• History of topical steroid or nonsteroidal anti-inflammatory drugs (NSAID) treatment in the study eye within 30 days prior to randomization

• Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization

• Initiation of intensive insulin treatment (multiple daily injections or a pump) within 3 months prior to randomization or plans to do so in the next 4 months

• Change in oral antidiabetic medication within 3 months prior to randomization

• Patients with a clinically relevant abnormal screening haematology, blood chemistry, or urinalysis

• Renal impairment with estimated creatinine clearance < 30 mL/min (as calculated by Cockcroft-Gault equation)

• Myocardial infarction or unstable angina pectoris within 3 months before randomization

• Uncontrolled arterial hypertension defined as a single measurement of systolic >180 mmHg, two consecutive measurements of systolic >160 mmHg, or diastolic >100mmHg on optimal medical regimen

• Further exclusion criteria apply

Related Conditions & MeSH terms

• Edema
• Macular Edema

Intervention

Drug:
• BI 1026706

• Placebo

Locations

Country	Name	City	State
Belgium	Brussels-UNIV Brugmann -Horta	Brussel
Belgium	Leuven - UNIV UZ Leuven (Sint-Rafaël)	Leuven
France	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
Germany	Universitätsklinikum Aachen, AöR	Aachen
Germany	Augen Zentrum Nordwest, Ahaus	Ahaus
Germany	Kamppeter Augenzentrum, Bayreuth	Bayreuth
Germany	Universitätsmedizin Göttingen, Georg-August-Universität	Göttingen
Germany	Universitätsmedizin der Johannes Gutenberg-Universität Mainz	Mainz
Germany	Augenarzt Dr. Dunker und Kollegen, Troisdorf	Troisdorf-Sieglar
Germany	Universitätsklinikum Tübingen	Tübingen
Germany	Universitätsklinikum Ulm	Ulm
Greece	Attikon, Panepistimiako Geniko Nosokomeio	Athens
Greece	University General Hospital of Heraklion	Herakleion,Crete
Greece	University of Patras Medical School	Patras
Hungary	Uzsoki Street Hospital, Budapest	Budapest
Hungary	BAZ County Hospital, Ophtalmology Department, Miskolc	Miskolc
Hungary	Univ.Szeged;Szent-Gyorgyi;Albert Heal.Cent.Ophtalmology Dep	Szeged
Portugal	Hospital de Braga-Escala Braga	Braga
Portugal	AIBILI - Association for Innovation and Biomedical Research on Light and Image	Coimbra
Portugal	Centro Hospitalar São João,EPE	Porto
Portugal	Hospital de Vila Franca de Xira	Vila Franca de Xira
Spain	Hospital Dos de Maig	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital La Paz	Madrid
Spain	Instituto Oftalmológico Gómez-Ulla	Santiago de Compostela
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
United Kingdom	Frimley Park Hospital	Frimley
United Kingdom	Royal Surrey County Hospital	Guildford
United Kingdom	Moorfields Eye Hospital	London
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne
United Kingdom	Southampton General Hospital	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Greece,  Hungary,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Central Subfield Foveal Thickness (CSFT) at 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.	Baseline and Week 12
Secondary	Number of Subjects With Serious Adverse Events (SAEs), Investigator Defined Drug-related Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)	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.	From first drug administration until 4 days after last drug administration, up to 89 days.

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