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Monoclonal Antibodies
A Study to Test Different Doses of BI 836880 in Patients With an Eye Disease Called Wet Age-related Macular Degeneration (wAMD)
Phase 1 & 2
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from last drug administration at week 8 until end of trial, up to 16 weeks.
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new medicine injected into the eye for people with a certain eye condition who haven't responded to other treatments. The goal is to see if it can help control new blood vessel growth and improve vision.
Eligible Conditions
- Age-Related Macular Degeneration (AMD)
- Age-Related Macular Degeneration
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from last drug administration at week 8 until end of trial, up to 16 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from last drug administration at week 8 until end of trial, up to 16 weeks.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
MRD-part: Number of Participants With Drug Related Adverse Events (AEs)
SRD-part: Number of Participants With Ocular Dose Limiting Events (DLEs)
Secondary study objectives
MRD-part: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 12
MRD-part: Number of Participants With Any Ocular Adverse Events in the Study Eye
MRD-part: Percentage Change From Baseline in Central Subfield Thickness (CSFT) in the Study Eye at Week 12
+3 moreSide effects data
From 2023 Phase 1 & 2 trial • 43 Patients • NCT0386123425%
Oxygen saturation abnormal
25%
Chronic obstructive pulmonary disease
25%
Palpitations
25%
Vitreous floaters
25%
Urinary tract infection
25%
Blood glucose increased
25%
Heart rate irregular
25%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
2 mg BI 836680 - Cohort 2 MRD Part
0.5 mg BI 836880 - SRD Part
0.06 mg BI 836880 - SRD Part
1 mg BI 836880 - SRD Part
1 mg BI 836880 - Cohort 1 MRD Part
0.18 mg BI 836880 - SRD Part
2 mg BI 836880 - SRD Part
2 mg BI 836680 - Cohort 3 MRD Part
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
8Treatment groups
Experimental Treatment
Group I: 2 mg BI 836880 - SRD partExperimental Treatment1 Intervention
Group II: 2 mg BI 836680 - cohort 3 MRD partExperimental Treatment1 Intervention
Group III: 2 mg BI 836680 - cohort 2 MRD partExperimental Treatment1 Intervention
Group IV: 1 mg BI 836880 - cohort 1 MRD partExperimental Treatment1 Intervention
Group V: 1 mg BI 836880 - SRD partExperimental Treatment1 Intervention
Group VI: 0.5 mg BI 836880 - SRD partExperimental Treatment1 Intervention
Group VII: 0.18 mg BI 836880 - SRD partExperimental Treatment1 Intervention
Group VIII: 0.06 mg BI 836880 - SRD partExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 836880
2016
Completed Phase 2
~370
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,551 Previous Clinical Trials
15,857,982 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are a man or woman who is 55 years or older and have a new case of blood vessels growing in the wrong place in your eyes due to age-related macular degeneration (AMD) and have not received any previous treatment for it.People who are 55 years or older and have been diagnosed with age-related macular degeneration (AMD).You are a patient with treatment-resistant wet age-related macular degeneration (wAMD).You have other eye diseases in the study eye that could affect your vision, such as visual field loss, uncontrolled glaucoma, diabetic maculopathy, or certain genetic disorders. You also have a history of high myopia in the study eye. There are abnormalities in the front part of your eye or in the gel-like substance inside your eye that would make it difficult to observe using a special imaging technique called SD-OCT.This part of the study is for patients who have not received any previous treatment for wet age-related macular degeneration (wAMD).
Research Study Groups:
This trial has the following groups:- Group 1: 0.5 mg BI 836880 - SRD part
- Group 2: 2 mg BI 836880 - SRD part
- Group 3: 0.06 mg BI 836880 - SRD part
- Group 4: 0.18 mg BI 836880 - SRD part
- Group 5: 1 mg BI 836880 - SRD part
- Group 6: 1 mg BI 836880 - cohort 1 MRD part
- Group 7: 2 mg BI 836680 - cohort 2 MRD part
- Group 8: 2 mg BI 836680 - cohort 3 MRD part
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.