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Monoclonal Antibodies

BI 765128 for Diabetic Retinopathy (PARTRIDGE Trial)

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 20 weeks
Awards & highlights

Summary

This trial is testing a new medication for diabetic macular ischemia to see if it is safe and effective. The study will last for about 4-5 months, and participants will be monitored for any side effects.

Eligible Conditions
  • Diabetic Retinopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 20 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Number of subjects with ocular dose limiting events (DLEs) from drug administration until day 8 (7 days after treatment)
Part B: Number of subjects with drug related Adverse Events (AEs) from drug administration until end of study (EOS)
Secondary outcome measures
Part A: Number of subjects with any ocular Adverse Events (AEs) (eye disorders) at end of study (EOS)
Part A: Number of subjects with drug related Adverse Events (AEs) at end of study (EOS)
Part B: Change from baseline of best corrected visual acuity (BCVA) at Visit 7
+4 more

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: BI 765128Experimental Treatment1 Intervention
Highest safe dose from Part A
Group II: Part A: BI 765128 medium doseExperimental Treatment1 Intervention
Group III: Part A: BI 765128 low doseExperimental Treatment1 Intervention
Group IV: Part A: BI 765128 high doseExperimental Treatment1 Intervention
Group V: Part B: Sham comparatorPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 765128
2021
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,516 Previous Clinical Trials
11,347,300 Total Patients Enrolled
4 Trials studying Diabetic Retinopathy
362 Patients Enrolled for Diabetic Retinopathy
~12 spots leftby Jul 2025