A study to test different doses of BI 836880 in patients with an eye disease called wet age-related macular degeneration (wAMD)

Phase 1

• Conditions: wet age-related macular degeneration (wAMD); MedDRA version: 20.1Level: PTClassification code 10064930Term: Age-related macular degenerationSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 20.0Level: LLTClassification code 10075568Term: Wet age-related macular degenerationSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 20.0Level: LLTClassification code 10075718Term: Exudative age-related macular degenerationSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2017-001221-40-DE
• Lead Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-04
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 42

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

- 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>- Number of patients with ocular dose limiting events (DLEs).<br><br>MRD Part:<br>- Number of patients with drug related AEs.;Timepoint(s) of evaluation of this end point: SRD Part:<br>7 days after Primary Treatment<br><br>MRD Part:<br>After EOT

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): SRD Part:<br>- Number of patients with drug related AEs<br>- Number of patients with any ocular AEs in the study eye<br><br><br>MRD Part:<br>- Percent change from baseline in Central Subfield Thickness (CSFT) in the study eye at week 12, for each dose <br>- Change from baseline in BCVA in the study eye at week 12<br>- Time to recurrence after the last treatment<br>- Number of patients with any ocular AEs in the study eye<br>;Timepoint(s) of evaluation of this end point: SRD Part:<br>- week 12<br><br>MRD Part:<br>- week 12 <br>- last treatment