BI 765128 for Diabetic Retinopathy
(PARTRIDGE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to determine if a new medicine, BI 765128, is safe for individuals with diabetic macular ischemia, a condition affecting the back of the eye, following laser treatment. In the first part of the study, participants receive varying doses of the medicine to identify the highest tolerable dose. In the second part, some participants receive the actual medicine, while others receive a placebo, which contains no active ingredients. This trial is suitable for those with diabetic macular ischemia who have already undergone laser treatment. As a Phase 1, Phase 2 trial, it offers participants the opportunity to be among the first to receive a new treatment and contribute to measuring its effectiveness.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications known to be toxic to the eye, like chloroquine or tamoxifen. If you are receiving certain eye treatments, like anti-VEGF injections, you must not have had them in the last 3 months before the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that BI 765128 is undergoing safety testing in people with diabetic macular ischemia. This trial marks the first administration of the drug to humans. Due to the early stage of testing, limited information exists on its tolerability.
In similar early-stage studies, researchers closely monitor for side effects, aiming to identify the highest dose that can be taken without major problems. So far, no serious issues have been reported with BI 765128, but further tests are necessary to confirm its safety for all. Participants in the trial will be closely monitored to promptly detect any unwanted effects.12345Why do researchers think this study treatment might be promising for diabetic macular ischemia?
Researchers are excited about BI 765128 because it offers a potentially new way to treat diabetic macular ischemia, a condition that currently relies heavily on laser treatments like panretinal photocoagulation. Unlike these existing options, BI 765128 is administered through an intravitreal injection, directly targeting the affected area in the eye. This method might provide more direct and effective relief by delivering the treatment precisely where it's needed. Additionally, the study explores varying doses, which could lead to a more personalized treatment plan based on individual patient needs. This innovative approach could not only improve outcomes but also reduce the need for more invasive procedures.
What evidence suggests that BI 765128 might be an effective treatment for diabetic macular ischemia?
Research shows that BI 765128 could be a promising treatment for diabetic macular ischemia, a condition that can cause vision loss. This study marks the first time BI 765128 is administered to people. Participants will receive varying doses of BI 765128, either as a single or multiple dose, to evaluate its effectiveness and safety. The treatment targets specific processes involved in diabetic eye problems, aiming to improve blood flow in the retina, which might help protect vision. Early results suggest that treatments targeting similar processes can help manage diabetic eye issues. However, more research is needed to confirm that BI 765128 is effective and safe for treating diabetic macular ischemia.34567
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single Rising Dose Part
Participants receive a single intravitreal injection of low, medium, or high dose of BI 765128
Multiple Dose Part
Participants receive monthly intravitreal injections of high-dose BI 765128 or sham injections for 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BI 765128
- Sham comparator
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor