OTX-TKI for Diabetic Retinopathy
(HELIOS-3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment called OTX-TKI (Axitinib Implant) to determine its safety and effectiveness for individuals with Non-Proliferative Diabetic Retinopathy, a common eye issue in diabetics. OTX-TKI is a special gel that releases medicine slowly in the eye over time. Participants will receive either the OTX-TKI treatment or a placebo injection to compare results. Individuals with type 1 or 2 diabetes who have serious but not advanced diabetic eye disease may be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you have had certain eye treatments like anti-VEGF injections in the last 6 months, you may not be eligible.
Is there any evidence suggesting that OTX-TKI is likely to be safe for humans?
Research has shown that OTX-TKI, an eye implant containing the drug axitinib, is generally safe for people. In earlier studies, patients with diabetic retinopathy received this implant and tolerated it well, with no major safety issues reported. The implant releases the drug slowly, helping to reduce side effects.
Some studies also noted improvements in eye health, such as better scores on a diabetic retinopathy scale. This suggests that the treatment is not only safe but might also be effective. No reports of serious unwanted effects from the treatment have emerged, which is encouraging for those considering joining the trial.12345Why do researchers think this study treatment might be promising for diabetic retinopathy?
Researchers are excited about OTX-TKI for diabetic retinopathy because it offers a new way to deliver treatment. Unlike standard treatments that often involve frequent injections, OTX-TKI uses an axitinib implant administered via a single or bi-annual intravitreal injection. This implant gradually releases medication over time, potentially reducing the treatment burden for patients. Moreover, axitinib, the active ingredient, targets abnormal blood vessel growth in the eye differently compared to existing therapies, which could lead to improved outcomes.
What evidence suggests that OTX-TKI might be an effective treatment for diabetic retinopathy?
Research has shown that OTX-TKI, a type of implant, can effectively treat Non-Proliferative Diabetic Retinopathy, a condition affecting the eyes. In this trial, participants will receive either OTX-TKI every 24 weeks, OTX-TKI as a single dose, or a sham procedure. Studies indicate that patients receiving OTX-TKI either maintained or improved their eye health. Specifically, one study found that after 12 months, this treatment was as effective as another known treatment, aflibercept. Notably, there was an 89% decrease in the need for additional treatments within a year for those using OTX-TKI. These findings suggest that OTX-TKI can effectively manage diabetic retinopathy and may reduce the frequency of required treatments.16789
Who Is on the Research Team?
Allen Hu, MD
Principal Investigator
Cumberland Valley Retina Consultants
Are You a Good Fit for This Trial?
This trial is for individuals with Non-Proliferative Diabetic Retinopathy. Participants must be eligible based on specific inclusion and exclusion criteria set by the study, which are not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive OTX-TKI or sham procedure. OTX-TKI is administered via intravitreal injection, releasing axitinib over time.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with primary outcome measured at Week 52.
What Are the Treatments Tested in This Trial?
Interventions
- OTX-TKI (Axitinib Implant)
Trial Overview
The trial tests OTX-TKI (axitinib implant) effectiveness and safety in treating diabetic eye disease. It compares a single injection of OTX-TKI followed by a mock procedure at Week 24 to two injections of OTX-TKI or two sham procedures.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
OTX-TKI 0.45 mg via intravitreal (IVT) administration at Day 1 and sham procedure at Week 24
OTX-TKI 0.45 mg via IVT administration at Day 1 and Week 24
Sham procedure at Day 1 and Week 24
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ocular Therapeutix, Inc.
Lead Sponsor
Citations
A Study to Evaluate the Efficacy and Safety of OTX-TKI ...
The purpose of this trial is to study the safety and effectiveness of OTX-TKI (axitinib intravitreal hydrogel) for the treatment of Non-Proliferative Diabetic ...
2.
europe.ophthalmologytimes.com
europe.ophthalmologytimes.com/view/helios-trial-1-year-results-assess-implant-for-treatment-of-non-proliferative-diabetic-retinopathyHELIOS trial 1-year results assess implant for treatment of ...
According to investigators, the treatment showed stability or improvement in the Diabetic Retinopathy Severity Scale (DRSS) and generally the ...
Phase 1 Results from Intravitreal Axitinib Implant (OTX-TKI) for ...
OTX-TKI's efficacy and safety profiles have not been established, and it has not been approved for marketing by the U.S. Food and Drug Administration (FDA) or ...
Twelve-month Data From a Phase 1 Clinical Trial of OTX- ...
The 12-month US randomized trial results have shown that OTX-TKI (n=15) exhibits anatomic and functional outcomes comparable with aflibercept (n ...
5.
modernretina.com
modernretina.com/view/12-month-data-for-otx-tki-shows-positive-results-for-treatment-of-wet-amd12-month data for OTX-TKI shows positive results ...
Overall, an 89% reduction in treatment burden was observed in OTX-TKI treated subjects at 12 months. “We are encouraged by the 12-month data as ...
OTX-TKI nAMD U.S. Phase 1
• Phase 1 study evaluating OTX-TKI in subjects with Diabetic Retinopathy - initiated in December 2022 ... implant showed safety, tolerability, and ...
Retina Society 2024 – Late Breaking Session
At 48 weeks, 23% of the OTX-TKI arm had a ≥2 step DRSS improvement (and 46.2% had a 1 or ≥2 step DRSS improvement), versus 0% in the sham group.
OTX-TKI May Decrease Retinal Leakage in NPDR
OTX-TKI May Decrease Retinal Leakage in NPDR. A post hoc analysis of imaging from the HELIOS trial suggests a durable effect from the ...
Study to Evaluate the Efficacy and Safety of Intravitreal OTX ...
A phase I study of OTX-TKI, an intravitreal implant containing axitinib, demonstrated a significant reduction in injection frequency for wet AMD patients.
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