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
NCT ID: NCT04615325
Last Updated: 2023-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
37 participants
INTERVENTIONAL
2020-12-08
2023-01-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Single Ascending Dose Stage
Participants will receive a single dose of RO7303359, in multiple escalating cohorts (A-D).
RO7303359
RO730359 will be administered as a single intravitreal injection.
Expansion Cohort Stage
Participants will receive the maximum tolerated dose (MTD) or the maximum tested dose (MTeD) as determined in the single ascending dose stage.
RO7303359
RO730359 will be administered as a single intravitreal injection.
Optional Cohort E
An optional additional cohort may be added with the dose not exceed the MTD or MTeD.
RO7303359
RO730359 will be administered as a single intravitreal injection.
Optional cohort F
An optional additional cohort may be added with the dose not exceed the MTD or MTeD.
RO7303359
RO730359 will be administered as a single intravitreal injection.
Interventions
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RO7303359
RO730359 will be administered as a single intravitreal injection.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Northern California Retina Vitreous Associates
Mountain View, California, United States
Retinal Consultants Med Group
Sacramento, California, United States
California Retina Consultants - Santa Maria
Santa Maria, California, United States
Colorado Retina Associates, PC
Denver, Colorado, United States
Florida Eye Associates
Melbourne, Florida, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, United States
Associated Retinal Consultants PC
Royal Oak, Michigan, United States
Sierra Eye Associates
Reno, Nevada, United States
Western Carolina Retinal Associate PA
Asheville, North Carolina, United States
Tennessee Retina PC.
Nashville, Tennessee, United States
Austin Clinical Research LLC
Austin, Texas, United States
Retina Foundation of the Southwest
Dallas, Texas, United States
Countries
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References
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Pearlman JA, Sheth VS, Khanani AM, Indjeian VB, Brunstein F, Kuruvilla D, Maia M, Dere R, Ma L, Chen H, Datta S, Willis JR, Wiley HE. Phase I Study of the Anti-interleukin 33 Fragment Antigen-Binding Region RO7303359 in Geographic Atrophy Secondary to Age-Related Macular Degeneration. Ophthalmol Sci. 2025 Apr 20;5(5):100800. doi: 10.1016/j.xops.2025.100800. eCollection 2025 Sep-Oct.
Other Identifiers
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GR42163
Identifier Type: -
Identifier Source: org_study_id
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