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
Verified date | February 2023 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
United States,
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 |
Status | Clinical Trial | Phase | |
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