Clinical trial NCT04615325: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Geographic Atrophy
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2020-11-04
Enrollment: 37
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Ocular Adverse Events
timeFrame: Up to 12 weeks
measure: Percentage of Participants With Systemic Adverse Events
timeFrame: Up to 12 weeks
measure: Percentage of Participants With Dose-limiting Adverse Events (DLAEs),
timeFrame: Up to 12 weeks
measure: Percentage of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to 12 weeks
measure: Percentage of Participants With Adverse Events Leading to Study Discontinuation
timeFrame: Up to 12 weeks
measure: Percentage of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: Up to 12 weeks
measure: Change from Baseline in Best Corrected Visual Acuity (BCVA) Score as Assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
timeFrame: Baseline, Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Sacramento
country: United States
facility: Retinal Consultants Med Group
state: California
city: Santa Maria
country: United States
facility: California Retina Consultants - Santa Maria
state: California
city: Denver
country: United States
facility: Colorado Retina Associates, PC
state: Colorado
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Oak Forest
country: United States
facility: University Retina and Macula Associates, PC
state: Illinois
city: Royal Oak
country: United States
facility: Associated Retinal Consultants PC
state: Michigan
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Asheville
country: United States
facility: Western Carolina Retinal Associate PA
state: North Carolina
city: Nashville
country: United States
facility: Tennessee Retina PC.
state: Tennessee
city: Austin
country: United States
facility: Austin Clinical Research LLC
state: Texas
city: Dallas
country: United States
facility: Retina Foundation of the Southwest
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: