wet age-related macular degeneration (wAMD) MedDRA version: 20.1 Level: PT Classification code 10064930 Term: Age-related macular degeneration System Organ Class: 10015919 - Eye disorders MedDRA version: 20.0 Level: LLT Classification code 10075568 Term: Wet age-related macular degeneration System Organ Class: 10015919 - Eye disorders MedDRA version: 20.0 Level: LLT Classification code 10075718 Term: Exudative age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Code: BI 836880
Pharmaceutical Form: Concentrate for solution for injection
Current Sponsor code: BI 836880
Other descriptive name: BI 836880
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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. MRD cohort 2: - Men and women over the age of 55 with treatment-naïve CNV secondary to AMD. - Any CNV with subfoveal activity in the study eye defined as evidence of sub- and/or intraretinal fluid, or subretinal hyper-reflective material, or angiographic leakage. - Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) VA in the study eye between 80 and 24 letters inclusive (approximately 20/25 and 20/320 or 6/7.5 and 6/95) at screening. - Best-corrected ETDRS VA in the non-study eye 50 letters inclusive (approximately 20/100 or 6/30) or better at screening. - If both eyes are eligible at screening, the study eye is the eye with the worse best-corrected VA. All trial parts: - No subretinal hemorrhage involving the fovea in the study eye. - No subfoveal fibrosis or atrophy on SD-OCT in the study eye. - Female subjects must be of non-childbearing potential. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 37
Exclusion criteria
Exclusion criteria: - 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. - Previous participation in other trials for treatment of wAMD with systemic administration if washout period from last administration is shorter than 3 months. - MRD cohort 1: Previous participation in other trials for treatment of wAMD with IVT injections in the study eye if washout period from last administration/injection is shorter than 3 months (IVT injections allowed if fellow eye was treated). - MRD cohort 2: No previous IVT injections for wAMD in the study eye (IVT injections allowed if fellow eye was treated).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the safety, tolerability and pharmacodynamics of single and multiple intravitreal doses of BI 836880.;Secondary Objective: Not applicable.;Primary end point(s): SRD Part: - Number of patients with ocular dose limiting events (DLEs). MRD Part: - Number of patients with drug related AEs.;Timepoint(s) of evaluation of this end point: SRD Part: 7 days after Primary Treatment MRD Part: After EOT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): SRD Part: - Number of patients with drug related AEs - Number of patients with any ocular AEs in the study eye MRD Part: - Percent change from baseline in Central Subfield Thickness (CSFT) in the study eye at week 12, for each dose - Change from baseline in BCVA in the study eye at week 12 - Time to recurrence after the last treatment - Number of patients with any ocular AEs in the study eye ;Timepoint(s) of evaluation of this end point: SRD Part: - week 12 MRD Part: - week 12 - last treatment | — |
Countries
Germany, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed