RO7303359 for Macular Degeneration

No longer recruiting at 16 trial locations

Overseen By Reference Study ID Number: GR42163 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hoffmann-La Roche

Disqualifiers: Vitrectomy, Laser photocoagulation, Photodynamic therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called RO7303359 for individuals with geographic atrophy (GA) due to age-related macular degeneration (AMD), a condition that causes vision loss. The trial aims to assess the safety and tolerability of the treatment when administered as an eye injection and to understand the body's response. Participants will receive either a single dose or the maximum dose deemed safe in earlier stages. Ideal candidates for this trial have GA without certain eye conditions or past treatments and face significant challenges in daily vision tasks. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that RO7303359 is likely to be safe for humans?

Research has shown that RO7303359 is generally safe based on earlier studies. Patients who received single eye injections of RO7303359 experienced no serious side effects. Some mild eye-related issues occurred, but they did not necessitate a change in dosage. These results suggest that the treatment is usually well-tolerated in people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about RO7303359 for geographic atrophy secondary to age-related macular degeneration because it offers a new approach compared to existing treatments. Unlike current options that mainly focus on slowing vision loss through vitamins or injections like anti-VEGF therapies, RO7303359 is administered via intravitreal injection and targets a different pathway, potentially addressing underlying causes of the disease. This unique mechanism of action could provide a more effective way to preserve vision and slow disease progression, sparking hope for better outcomes in patients with this challenging condition.

What evidence suggests that RO7303359 might be an effective treatment for geographic atrophy?

Research has shown that RO7303359, a new eye injection, might help people with vision loss from age-related macular degeneration (AMD). In this trial, participants will receive RO7303359 in different stages. Early results indicate that this treatment is safe in single doses up to 20 mg. The drug targets interleukin 33, a protein linked to inflammation, suggesting it could reduce harmful inflammation in the eye. Although more human studies are needed, these early findings offer hope that it could slow the progression of geographic atrophy, a condition leading to vision loss in AMD. ^{1 2 5 6 7}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

Inclusion Criteria

You have GA secondary to AMD in the absence of CNV.

Ocular

You have a disc area of at least 1.25 mm2.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose Stage

Participants receive a single dose of RO7303359 in multiple escalating cohorts

4 weeks

Expansion Cohort Stage

Participants receive the maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RO7303359

How Is the Trial Designed?

Group I: Single Ascending Dose Stage Experimental Treatment 1 Intervention

Participants will receive a single dose of RO7303359, in multiple escalating cohorts (A-D).

Group II: Optional cohort F Experimental Treatment 1 Intervention

An optional additional cohort may be added with the dose not exceed the MTD or MTeD.

Group III: Optional Cohort E Experimental Treatment 1 Intervention

An optional additional cohort may be added with the dose not exceed the MTD or MTeD.

Group IV: Expansion Cohort Stage Experimental Treatment 1 Intervention

Participants will receive the maximum tolerated dose (MTD) or the maximum tested dose (MTeD) as determined in the single ascending dose stage.

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

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

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666914525000983

Phase I Study of the Anti-interleukin 33 Fragment Antigen ... Results. Thirty-seven patients enrolled in the dose cohorts. Single IVT doses of RO7303359 demonstrated an acceptable safety profile up to 20 mg, with mild ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04615325

NCT04615325 | A Study Evaluating the Safety, Tolerability ... This multicenter study will investigate the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 following single intravitreal (ITV) ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40538770/

Phase I Study of the Anti-interleukin 33 Fragment Antigen ... Results: Thirty-seven patients enrolled in the dose cohorts. Single IVT doses of RO7303359 demonstrated an acceptable safety profile up to 20 mg ...

4. synapse.patsnap.com synapse.patsnap.com/drug/7f391cb6e652426ca1c5dd433a86e694

RO-7303359 - Drug Targets, Indications, Patents Clinical Results associated with RO-7303359. Login to view more ... announced positive preliminary efficacy and safety data from the ...

5. withpower.com withpower.com/trial/phase-1-atrophy-11-2020-cb367

A Study Evaluating the Safety, Tolerability, Pharmacokinetics ... This trial is testing a new drug called RO7303359, which is injected directly into the eye. It aims to help people with vision loss due to age-related ...

6. ophthalmologyscience.org ophthalmologyscience.org/article/S2666-9145(25)00098-3/fulltext

Phase I Study of the Anti-interleukin 33 Fragment Antigen ... Safety. Single IVT injections of RO7303359 showed acceptable safety in patients with GA secondary to AMD. No dose-limiting AEs were reported in this study ...

7. forpatients.roche.com forpatients.roche.com/en/trials/eye-disorder/amd/a-study-to-evaluate-the-safety--tolerability--pharmacok-30793.html

Clinical trial – age-related macular degeneration and geo... The study of a new medicine (RO7303359) in people with a type of eye disease (geographic atrophy secondary to age‑related macular degeneration ).