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Monoclonal Antibodies
BI 836880 for Age-Related Macular Degeneration
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 up to 169 days
Awards & highlights
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)
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 169 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 169 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Multiple Rising Dose (MRD) part: Number of patients with drug related Adverse Events (AEs) from drug administration until end of trial (EOT)
Lupus Erythematosus, Discoid
Secondary outcome measures
Eye
Multiple Rising Dose (MRD) part: Number of patients with any ocular AEs in the study eye
Eye
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: BI 836880Experimental Treatment1 Intervention
Single Rising Dose part followed by a Multiple Rising Dose part
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 836880
2016
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,516 Previous Clinical Trials
11,347,303 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: BI 836880
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.
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