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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

PARTRIDGE Trial 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

PARTRIDGE Trial 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

PARTRIDGE 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
2,507 Previous Clinical Trials
11,340,527 Total Patients Enrolled
4 Trials studying Diabetic Retinopathy
359 Patients Enrolled for Diabetic Retinopathy

Frequently Asked Questions

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

How many different locations are overseeing the running of this clinical trial?

"There are 17 medical centres that are offering this trial, with Erie Retina Research LLC in Erie, Valley Retina Institute PA in McAllen, and Meridian Clinical Research LLC in Cincinnati being key sites. Additionally there are 14 other locations available for participation."

Answered by AI

Are there any open vacancies for this research endeavor?

"Clinicaltrials.gov has reported that this clinical trial, which was first launched on July 30th 2021, is actively enrolling participants. The posting was last updated November 30th 2022."

Answered by AI

Are there any limitations to the number of subjects participating in this research?

"This medical trial needs 48 volunteers that meet the established eligibility requirements. Participents can join this research at Erie Retina Research, LLC (Erie, Pennsylvania) and Valley Retina Institute, PA (McAllen, Texas)."

Answered by AI

Who else is applying?

What state do they live in?
California
Louisiana
Texas
How old are they?
18 - 65
What site did they apply to?
University of California Los Angeles
Valley Retina Institute, PA
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have been to multiple doctors here in Louisiana with no help, i am determined to see again!
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study of BI 765128 in Patients With an Eye Condition Called Diabetic Macular Ischemia Who Have Received Laser Treatment
2021. "A Study of BI 765128 in Patients With an Eye Condition Called Diabetic Macular Ischemia Who Have Received Laser Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04919499.
~13 spots leftby Apr 2025
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