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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
SRD part and MRD cohort 1 (treatment-resistant patients with wAMD):
MRD cohort 2 (treatment-naive patients with wAMD):
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 169 days
Awards & highlights

Study Summary

This trialwill assess how well different doses of a medicine called BI 836880 are tolerated to treat wet age-related macular degeneration (wAMD). Participants receive the medicine injected into their eyes and are monitored over 6 weeks or 6 months.

Eligible Conditions
  • Age-Related Macular Degeneration (AMD)

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are a patient with treatment-resistant wet age-related macular degeneration (wAMD).
Select...
This part of the study is for patients who have not received any previous treatment for wet age-related macular degeneration (wAMD).
Select...
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.
Select...
People who are 55 years or older and have been diagnosed with age-related macular degeneration (AMD).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 169 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 169 days for reporting.

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 more

Trial 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
2,494 Previous Clinical Trials
11,338,935 Total Patients Enrolled

Media Library

BI 836880 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03861234 — Phase 1 & 2
Age-Related Macular Degeneration Research Study Groups: BI 836880
Age-Related Macular Degeneration Clinical Trial 2023: BI 836880 Highlights & Side Effects. Trial Name: NCT03861234 — Phase 1 & 2
BI 836880 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03861234 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide me with a figure of the total participants in this research venture?

"Affirmative. Records hosted on clinicaltrials.gov indicate that this medical study, which first appeared June 27th 2019, is actively enrolling patients. A total of 42 people need to be recruited from 8 different centres."

Answered by AI

How widespread is the implementation of this research project?

"Participants for this clinical trial are being recruited from Retina Institute of California Medical Group in Palm Desert, Cumberland Valley Retina Consultants, PC. in Hagerstown and Retina Consultants of Texas located in Bellaire plus 8 other sites."

Answered by AI

Are researchers still inviting participants to join this investigation?

"According to the clinicaltrials.gov webpage, this medical trial is actively enrolling patients; it was first posted on June 27th 2019 and most recently modified on November 30th 2022."

Answered by AI
~7 spots leftby Mar 2025