RO7669330 for Age-Related Macular Degeneration

Recruiting at 16 trial locations

Overseen By Reference Study ID Number: BP45482 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hoffmann-La Roche

Must not be taking: Anti-VEGF, Syfovre, Izervay

Disqualifiers: Macular atrophy, CNV, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 32 weeks

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called RO7669330 for individuals with age-related macular degeneration (AMD), a condition that causes vision loss. The study aims to determine if the treatment is safe and well-tolerated when administered as an injection in the eye. Participants will receive either RO7669330 or other treatments like Syfovre or Izervay to compare their effects. Individuals experiencing a specific type of vision deterioration due to AMD, who have not undergone certain eye treatments, might be suitable for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have received certain eye treatments recently, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that RO7669330 is being tested for safety in people with age-related macular degeneration (AMD). This new treatment aims to assess how well people can tolerate it. As it is in the early testing stages, limited safety information is available. Early trials primarily ensure the treatment's safety for humans. Reaching this stage indicates it has passed initial safety checks in labs or animal studies.

The trial also compares RO7669330 to two other treatments, Syfovre and Izervay. These treatments are well-known and have been used in other studies, providing a better understanding of their safety. Although detailed information on RO7669330's side effects isn't available yet, researchers closely monitor for any possible side effects or negative reactions during these early tests. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about RO7669330 for age-related macular degeneration (AMD) because it offers a fresh approach compared to existing treatments like anti-VEGF injections. Unlike these standard treatments, which primarily focus on inhibiting blood vessel growth, RO7669330 may offer a novel mechanism of action, potentially providing a more comprehensive benefit for eye health. Additionally, the trial explores the possibility of combining RO7669330 with known treatments like Syfovre and Izervay, which could enhance its effectiveness. This innovative strategy gives hope for improved vision outcomes and a better quality of life for those with AMD.

What evidence suggests that this trial's treatments could be effective for age-related macular degeneration?

Research into RO7669330 remains in the early stages, so detailed information on its effectiveness for geographic atrophy (GA) related to age-related macular degeneration (AMD) is not yet available. This treatment involves an injection directly into the eye and targets specific pathways that damage the retina. Early signs suggest it might slow vision loss in AMD, but further research is needed. In this trial, participants will receive RO7669330 in one of the treatment arms.

In separate arms of this trial, participants will receive either Syfovre or Izervay. These treatments have shown promise in earlier studies, where they slowed the progression of GA in AMD patients. Like RO7669330, these treatments are injected into the eye and work by reducing inflammation or blocking harmful proteins. ^{1 2 4 5 6}

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 individuals with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). Participants must have clear ocular media, adequate pupillary dilation, and the ability to fixate for quality fundus imaging. Specific visual acuity requirements vary by part of the study: Part 1A requires 19-48 letters read, Part 1B more than 19 letters, and Part 2 at least 24 letters. GA size criteria also differ across parts.

Inclusion Criteria

My age is between 19 and 48.

My eye condition is fully visible in a specific eye test image.

My response exceeds 19 letters.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple unilateral intravitreal (IVT) doses of RO7669330 or active comparators in the study eye

Up to 32 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RO7669330

Trial Overview The trial is testing RO7669330's safety and effects on eyesight when given as multiple unilateral intravitreal doses in patients with GA due to AMD. It will look into how the body absorbs and responds to this drug (pharmacokinetics/pharmacodynamics), as well as any potential immune response against it.

How Is the Trial Designed?

Group I: Part 2: RO7669330 vs Active Comparator (Syfovre or Izervay) Experimental Treatment 3 Interventions

Participants will receive RO7669330 (at two dose levels) or the active comparator (either Syfovre or Izervay), as an IVT injection in the study eye.

Group II: Part 1B: Syfovre and Izervay Experimental Treatment 2 Interventions

Participants will receive either Syfovre, 15 milligrams (mg) or Izervay, 2 mg, as an IVT injection in the study eye.

Group III: Part 1A: Multiple Ascending Dose (MAD) Experimental Treatment 1 Intervention

Participants will receive multiple doses of RO7669330 as IVT injections in the study eye with additional cohorts of participants receiving higher doses of RO7669330.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06961370?lead=genentech%20OR%20Hoffmann-La%20Roche&viewType=Table&rank=9

NCT06961370 | A Study to Investigate Safety, Tolerability ... The main purpose of this study is to assess the ocular and systemic safety and tolerability of RO7669330 in GA secondary to AMD after multiple unilateral ...

2. trialx.com trialx.com/clinical-trials/listings/298454/a-study-to-investigate-safety-tolerability-pharmacokinetics-pk-pharmacodynamics-pd-and-immunogenicity-of-ro7669330-in-participants-with-geographic-atrophy-ga-secondary-to-age-related-macular-degeneration-amd/?&radius=50

Age-related Macular Degeneration ) ( NCT06961370 ) The main purpose of this study is to assess the ocular and systemic safety and tolerability of RO7669330 in GA secondary to AMD after multiple ...

3. withpower.com withpower.com/trial/ro7669330-for-age-related-macular-degeneration-38e14

RO7669330 for Age-Related Macular Degeneration The main purpose of this study is to assess the ocular and systemic safety and tolerability of RO7669330 in GA secondary to AMD after multiple unilateral ...

4. retinalphysician.com retinalphysician.com/issues/2025/june/clinical-trial-update/

Clinical Trial Update June 2025 Purpose: This is a phase 1/2 study to assess the safety and efficacy of OCU410 for geographic atrophy secondary to dry age-related macular ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06961370

NCT06961370 | A Study to Investigate Safety, Tolerability ... The main purpose of this study is to assess the ocular and systemic safety and tolerability of RO7669330 in GA secondary to AMD after multiple unilateral ...

6. forpatients.roche.com forpatients.roche.com/en/trials/eye-disorder/damd/a-study-to-investigate-safety--tolerability--pharmacoki-32726.html

Clinical trial for Age-Related Macular Degeneration, Geog... The main purpose of this study is to assess the ocular and systemic safety and tolerability of RO7669330 in GA secondary to AMD after multiple unilateral ...