A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy

• Status: Recruiting
• Trial end date: 2022-02-22
• Target enrollment: 0
• Participant gender: All

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). The participants will receive ITV injections of RO7303359 in the single ascending dose stage and maximum tolerated dose (MTD) or maximum tested dose (MTeD) of RO7303359 will be administered in the expansion stage.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Ocular Inclusion Criteria Study Eye:

• 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 mm2)

Ocular Exclusion Criteria, Study eye:

• GA 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 Visudyne, 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