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

Phase 1

Completed

• Conditions: Geographic Atrophy
• Interventions: Drug: RO7171009

• Registration Number: NCT03295877
• Lead Sponsor: Genentech, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-19
• Study Start: 2017-09-21
• Study First Submitted QC: 2017-09-26
• Study First Posted: 2017-09-28
• Primary Completion: 2018-11-20
• Study Completion: 2018-11-20
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
RO7171009: SAD	RO7171009	Patients will receive a single dose of RO7171009, in multiple escalating cohorts.
RO7171009: MD	RO7171009	Patients will receive RO7171009 at maximum tolerated dose (MTD), identified during the SAD stage for three doses.

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of the Study Drug: Rate of Adverse Events	Through study completion or early study discontinuation (overall 12-20 weeks)

Secondary Outcome Measures

Name	Time	Method
Serum Concentration of RO7171009	Through study completion or early study discontinuation (overall 12-20 weeks)

Trial Locations

Locations (12)

California Retina Consultants; 🇺🇸 Santa Barbara, California, United States

Northern California Retina Vitreous Associates; 🇺🇸 Mountain View, California, United States

Retinal Consultants Med Group; 🇺🇸 Sacramento, California, United States

California Retina Consultants - Santa Maria; 🇺🇸 Santa Maria, California, United States

Retina Consultants of Southern Colorado PC; Clinical Research Department; 🇺🇸 Colorado Springs, Colorado, United States

Florida Eye Associates; 🇺🇸 Melbourne, Florida, United States

Retina Specialty Institute; 🇺🇸 Pensacola, Florida, United States

Georgia Retina PC; 🇺🇸 Marietta, Georgia, United States

The Retina Institute; 🇺🇸 Saint Louis, Missouri, United States

Sierra Eye Associates; 🇺🇸 Reno, Nevada, United States

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