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

Boehringer Ingelheim

Status and phase

Completed

Phase 2

Conditions

Macular Edema

Treatments

Drug: Placebo

Drug: BI 1026706

Study type

Interventional

Funder types

Industry

Identifiers

NCT02732951

2015-003529-33 (EudraCT Number)

1320.22

Details and patient eligibility

About

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

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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