RO7669330 for Age-Related Macular Degeneration

Recruiting at 4 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

Trial Summary

What is the purpose of this trial?

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 intravitreal (IVT) doses.

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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 eye exam shows specific bright patterns near the damaged area.

Timeline

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

Treatment Details

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.

Participant Groups

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