RO7663498 for Diabetic Retinopathy
(CENOTE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called RO7663498 for individuals with diabetic retinopathy, an eye condition associated with diabetes. The main goal is to assess the safety and tolerability of the treatment when injected into the eye and to understand its behavior in the body. Participants will receive the treatment in different groups to collect more data. Individuals with diabetes who have non-proliferative diabetic retinopathy and can still see at least some letters on a vision test might be suitable for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that RO7663498 is likely to be safe for humans?
Researchers are conducting studies to determine the safety and tolerability of RO7663498 for individuals with diabetic retinopathy. Detailed safety information from previous studies is not yet available. As this is an early clinical trial, the focus is on identifying any potential side effects and understanding how the body processes the drug.
The primary goal in this early trial is to ensure the treatment does not cause serious harm. Reaching this stage indicates that earlier lab and animal tests suggested potential safety for humans. Participants will be closely monitored for any adverse effects. This careful observation ensures the treatment's safety before advancing to later testing stages.12345Why do researchers think this study treatment might be promising for diabetic retinopathy?
Most treatments for diabetic retinopathy focus on controlling blood sugar or using injections like anti-VEGF to reduce vision loss. But RO7663498 is different because it offers a new approach by potentially targeting different pathways involved in the disease. Researchers are excited about this treatment because it might provide an alternative for patients who don't respond well to current options, possibly offering better outcomes with fewer treatments.
What evidence suggests that RO7663498 might be an effective treatment for diabetic retinopathy?
Research has shown that RO7663498 is under investigation for its potential to treat diabetic retinopathy, a common eye problem in people with diabetes. This treatment involves an injection into the eye to address the issue directly. The trial currently focuses on understanding the drug's mechanism in the body and ensuring its safety, rather than proving its effectiveness in treating the condition. While specific results from human studies are not yet available, the drug's mechanism suggests it might help by addressing the root causes of eye damage. Early signs from similar treatments are promising, indicating they might reduce the severity of diabetic retinopathy.36789
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Are You a Good Fit for This Trial?
This trial is for people with diabetes (type 1 or type 2) who have non-proliferative diabetic retinopathy and enough vision in the study eye. Participants must be able to safely provide a small fluid sample from the eye.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive multiple ascending doses of RO7663498 via intravitreal injections
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- RO7663498
Trial Overview
The study is testing RO7663498, given as an injection into the eye, to see how safe it is, how well people tolerate it, and how it's processed by the body in those with diabetic retinopathy.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants will receive RO7663498.
Participants will receive RO7663498.
Participants will receive RO7663498.
Participants will receive RO7663498.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University
Citations
Diabetic Retinopathy Clinical Research Trials
Global estimates suggest that approximately 22-26% of people with diabetes have some degree of DR, with about 6% experiencing vision-threatening disease.
NCT03622580 | A Study to Evaluate the Efficacy and ...
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3.
linkedin.com
linkedin.com/posts/ophthopedia_ai-based-dr-severity-screening-tool-shows-activity-7473797151349907456-C17GOphthopedia Update: AI-based DR Screening Tool Efficacy
A single injection of sura-vec reduced the severity of nonproliferative diabetic retinopathy for up to 2 years, according to data
RO7663498 in Diabetic Retinopathy - Clinical Trials Registry
This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants ...
5.
linkedin.com
linkedin.com/posts/diana-girnita-md-phd-07b57810_rheumatology-gout-glp1-activity-7473072785314127873-JmcGGLP-1 Therapy's Biphased Effect on Gout | Diana Girnita ...
This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants with ...
6.
ctv.veeva.com
ctv.veeva.com/study/a-study-to-investigate-the-safety-tolerability-and-pharmacokinetics-of-ro7663498-following-intraviA Study to Investigate the Safety, Tolerability, and ...
This study will assess the safety, tolerability, and pharmacokinetics (PK) of intravitreal (IVT) injections of RO7663498 in participants ...
Semaglutide and the risk of diabetic retinopathy—current ...
The SUSTAIN 6 trial demonstrated a higher incidence of diabetic retinopathy (DR) a 0.8% increase in DR was observed with oral semaglutide [5]. ...
NCT06321302 | A Study to Test Whether BI 764524 Helps ...
The purpose of this study is to find out whether a medicine called BI 764524 helps people with diabetic retinopathy.
Case Definitions: Diabetic Retinopathy (DR)
VEHSS reports the annual prevalence of diagnosed diabetic eye diseases based on the presence of International Classification of Diseases (ICD)-9 and ICD-10 ...
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