Safety, tolerability and pharmacodynamics of single rising intravitreal and multiple rising intravitreal doses of BI 836880 in patients with wAMD (open label, non-randomized, uncontrolled).

Boehringer Ingelheim Pharma GmbH & Co. KG0 sites42 target enrollmentJanuary 4, 2019

Overview

No summary available.

Registry

who.int

Start Date

January 4, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•SRD part and MRD cohort 1:
•\- Men and women over the age of 55 with active CNV secondary to AMD despite anti\-VEGF therapies (at least 3 prior injections with the last
•injection within 16 to 4 weeks before treatment).
•\- For MRD cohort 1 only: Central subfield retinal thickness \>330 microns in the study eye.
•\- Presence of sub\- and/or intraretinal fluid on SD\-OCT in the study eye.
•\- Any active CNV with subfoveal leakage in the study eye as determined by OCT.
•\- Best\-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) VA in the study eye between 70 and 24 letters inclusive (approximately
•20/40 and 20/320 or 6/12 and 6/95\) at screening.
•\- Best\-corrected VA in the non\-study eye better than best\-corrected VA in the study\-eye. If both eyes are eligible and have identical VA the
•investigator may select the study eye.

•\- Additional eye disease in the study eye that could compromise best corrected VA (BCVA) with visual field loss, uncontrolled glaucoma (IOP\>24 mmHg on more than 2 consecutive measurements prior to screening), clinically significant diabetic maculopathy, history of ischemic optic neuropathy or retinalvascular occlusion, symptomatic vitreomacular traction, or genetic disorders such as retinitis pigmentosa);
•history of high myopia \>8 diopters in the study eye. Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation with SD\-OCT.
•\- Any prior intraocular surgery in the study eye other then uneventful lens replacement for cataract within 3 months prior to screening.
•\- Aphakia or total absence of the posterior capsule. Yttrium aluminum garnet (YAG) laser capsulotomy permitted, more than 1 month prior to
•enrollment in the study eye.
•\- Current or planned use of medications known to be toxic to the retina, lens or optic nerve.
•\- Active intraocular inflammation in the study eye.
•\- Active infectious conjunctivitis in either eye.
•\- Participation in trials:
•\- Previous participation in this trial.