Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

Genentech

Status and phase: Completed; Phase 1

Conditions: Geographic Atrophy

Treatments: Drug: RO7171009

Study type: Interventional

Funder types: Industry

Identifiers

NCT03295877

GR39821

Details and patient eligibility

About

This Phase 1, open-label, multicenter study will investigate the safety and tolerability of RO7171009 following single and multiple intravitreal (ITV) administrations in patients with GA secondary to AMD. The study consists of two stages: Single Dose-Escalation (SAD) and Multiple-Dose (MD) stages.

Enrollment: 28 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants aged greater than or equal to (>/=) 50 years
• Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in study eye

Exclusion criteria

Ocular Exclusion Criteria, Study Eye:

• History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
• Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy
• Prior treatment with Visudyne®, external beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy

Ocular Exclusion Criteria (Both Eyes):

• GA in either eye due to causes other than AMD
• Evidence of prior or active CNV
• Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, irrespective of the route of administration (i.e., ocular or systemic) within the last 6 months

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

28 participants in 2 patient groups

RO7171009: SAD

Experimental group

Description:

Patients will receive a single dose of RO7171009, in multiple escalating cohorts.

Treatment:

Drug: RO7171009

RO7171009: MD

Experimental group

Description:

Patients will receive RO7171009 at maximum tolerated dose (MTD), identified during the SAD stage for three doses.

Treatment:

Drug: RO7171009