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

Geographic Atrophy Clinical Trial

Official title:

A Phase I, Multicenter, Open-Label, Single-Dose, Dose-Escalation, and Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7171009 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03295877
• Other study ID #: GR39821
• Status: Completed
• Phase: Phase 1
• Start date: September 21, 2017
• Est. completion date: November 20, 2018

Study information

• Verified date: February 2020
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 20, 2018
• Est. primary completion date: November 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

Drug:
• RO7171009
Patients will receive RO7171009 via ITV injection.

Locations

Country	Name	City	State
United States	Western Carolina Retinal Associate PA	Asheville	North Carolina
United States	California Retina Consultants	Bakersfield	California
United States	Retina Consultants of Southern Colorado PC; Clinical Research Department	Colorado Springs	Colorado
United States	Georgia Retina PC	Marietta	Georgia
United States	Florida Eye Associates	Melbourne	Florida
United States	Northern California Retina Vitreous Associates	Mountain View	California
United States	Tennessee Retina PC.	Nashville	Tennessee
United States	Retina Specialty Institute	Pensacola	Florida
United States	Sierra Eye Associates	Reno	Nevada
United States	Retinal Consultants Med Group	Sacramento	California
United States	The Retina Institute	Saint Louis	Missouri
United States	California Retina Consultants	Santa Barbara	California
United States	California Retina Consultants - Santa Maria	Santa Maria	California

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability of the Study Drug: Rate of Adverse Events		Through study completion or early study discontinuation (overall 12-20 weeks)
Secondary	Serum Concentration of RO7171009		Through study completion or early study discontinuation (overall 12-20 weeks)