30 Participants NeededMy employer runs this trial

RO7663498 for Diabetic Retinopathy

(CENOTE Trial)

Recruiting at 2 trial locations
RS
RS
Fr
Fr
Overseen ByFastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Hoffmann-La Roche
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

CT

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

My eye meets the study's specific requirements.
My vision in the study eye is at least 19 letters on the ETDRS chart.
I meet the basic requirements to join this study.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple ascending doses of RO7663498 via intravitreal injections

8 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

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

Group I: Cohort 4Experimental Treatment1 Intervention
Group II: Cohort 3Experimental Treatment1 Intervention
Group III: Cohort 2Experimental Treatment1 Intervention
Group IV: Cohort 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials
2,482
Recruited
1,107,000+
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Avastin, Herceptin, Rituxan, Accu-Chek
Dr. Levi Garraway profile image

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker profile image

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Citations

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