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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

NCT04615325

CompletedPhase 1

Sponsor: Hoffmann-La Roche

Conditions: Geographic Atrophy

Interventions: RO7303359

Countries: United States

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 overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (12)

Mountain View, California, United States
Sacramento, California, United States
Santa Maria, California, United States
Denver, Colorado, United States
Melbourne, Florida, United States
Oak Forest, Illinois, United States
Royal Oak, Michigan, United States
Reno, Nevada, United States
Asheville, North Carolina, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States