A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy.
- Age-Related Macular Degeneration
Trial Status:
Recruiting
This trial runs in
Cities
- Asheville
- Austin
- Dallas
- Denver
- Los Angeles
- Melbourne
- Mountain View
- Nashville
- Oak Forest
- Reno
- Royal Oak
- Sacramento
- Santa Maria
Trial Identifier:
NCT04615325 GR42163
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). 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.
Hoffmann-La Roche
Sponsor
Phase 1
Phase
NCT04615325 , GR42163
Trial Identifier
RO7303359
Treatments
Geographic Atrophy
Condition
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
Eligibility Criteria
All
Gender
≥50 Years
Age
No
Healthy Volunteers
Inclusion 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)
Exclusion Criteria
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
For the latest version of this information please go to www.forpatients.roche.com