A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

Geographic Atrophy Clinical Trial

Official title:

A Phase 1a, Multicenter, Open-label, Single-dose, Dose-escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04615325
• Other study ID #: GR42163
• Status: Completed
• Phase: Phase 1
• Start date: December 8, 2020
• Est. completion date: January 4, 2023

Study information

• Verified date: February 2023
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This multicenter study will investigate the safety, tolerability, pharmacokinetics, and immunogenicity of RO7303359 following single intravitreal (ITV) injection in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Participants will receive an ITV injection of RO7303359 in the single ascending dose stage and the maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 in the expansion stage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 4, 2023
• Est. primary completion date: January 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Ocular Inclusion Criteria Study Eye:

• Visual acuity: BCVA letter score of 19-48 ETDRS letters (Snellen equivalent of 20/125-20/400) using ETDRS charts at a starting distance of 4 meters

• Well-demarcated area of GA secondary to AMD in the absence of choroidal neovascularization (CNV)

• GA area must be >/= 0.5 disc area (1.25 mm^2)

Ocular Exclusion Criteria, Study Eye:

• GA in the study eye due to causes other than AMD

• 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 photodynamic therapy, external beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy

Ocular Exclusion Criteria, Both eyes:

• 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:
• RO7303359
RO730359 will be administered as a single intravitreal injection.

Locations

Country	Name	City	State
United States	Western Carolina Retinal Associate PA	Asheville	North Carolina
United States	Austin Clinical Research LLC	Austin	Texas
United States	Retina Foundation of the Southwest	Dallas	Texas
United States	Colorado Retina Associates, PC	Denver	Colorado
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	University Retina and Macula Associates, PC	Oak Forest	Illinois
United States	Sierra Eye Associates	Reno	Nevada
United States	Associated Retinal Consultants PC	Royal Oak	Michigan
United States	Retinal Consultants Med Group	Sacramento	California
United States	California Retina Consultants - Santa Maria	Santa Maria	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Ocular Adverse Events		Up to 12 weeks
Primary	Percentage of Participants With Systemic Adverse Events		Up to 12 weeks
Primary	Percentage of Participants With Dose-limiting Adverse Events (DLAEs),		Up to 12 weeks
Primary	Percentage of Participants With Serious Adverse Events (SAEs)		Up to 12 weeks
Primary	Percentage of Participants With Adverse Events Leading to Study Discontinuation		Up to 12 weeks
Primary	Percentage of Participants With Adverse Events of Special Interest (AESIs)		Up to 12 weeks
Primary	Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart		Baseline, Week 12