Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
NCT03295877 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2020-02-12
Summary
This Phase 1, open-label, multicenter study will investigate the safety and tolerability of RO7171009 following single and multiple intravitreal (ITV) administrations in patients with GA secondary to AMD. The study consists of two stages: Single Dose-Escalation (SAD) and Multiple-Dose (MD) stages.
Conditions
Interventions
- DRUG
-
RO7171009
Patients will receive RO7171009 via ITV injection.
Sponsors & Collaborators
-
Genentech, Inc.
lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-09-21
- Primary Completion
- 2018-11-20
- Completion
- 2018-11-20
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)
NCT00658619 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
NCT02247479 ·Status: TERMINATED ·Phase: PHASE3
-
Intravitreal AAVCAGsCD59 for Advanced Dry Age-related Macular Degeneration (AMD) With Geographic Atrophy (GA)
NCT04358471 ·Status: WITHDRAWN ·Phase: PHASE2
-
Safety and Tolerability Study of AAV2-sFLT01 in Patients With Neovascular Age-Related Macular Degeneration (AMD)
NCT01024998 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluating RXI-109 to Reduce the Progression of Subretinal Fibrosis in Subjects With NVAMD
NCT02599064 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
First in Human Study to Evaluate the Safety and Tolerability of GEM103 in Geographic Atrophy Secondary to Dry Age Related Macular Degeneration
NCT04246866 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1/2 Study to Evaluate the Safety and Efficacy of Intravitreal Administration of BS01 in Patients With Geographic Atrophy Secondary to Dry AMD
NCT07158775 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Safety and Efficacy of AM712 in Patients with NAMD
NCT05345769 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration
NCT02087085 ·Status: TERMINATED ·Phase: PHASE2
-
Phase II/III Study of Anti-VEGF in Neovascular AMD
NCT00021736 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Long-Term Safety of Lampalizumab Intravitreal (ITV) Injections in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (OMASPECT)
NCT02745119 ·Status: TERMINATED ·Phase: PHASE3
-
A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
NCT02247531 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of RO6867461 Administered in Single- and Multiple-Ascending Doses in Patients With Wet Age-Related Macular Degeneration
NCT01941082 ·Status: COMPLETED ·Phase: PHASE1
-
A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)
NCT06635148 ·Status: RECRUITING ·Phase: PHASE2
-
Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).
NCT05893537 ·Status: TERMINATED ·Phase: PHASE2
-
An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa
NCT00661479 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
NCT07160179 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study Of The Safety And Efficacy Of AG-013,958 In Subjects With Subfoveal Choroidal Neovascularization Associated With Age-Related Macular Degeneration
NCT00090532 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7497372 in Participants With Diabetic Macular Edema (DME)
NCT06847854 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy
NCT02288559 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase II Study of Intravitreal KIO-301 in Patients With Late-stage Retinitis Pigmentosa
NCT06628947 ·Status: RECRUITING ·Phase: PHASE2
-
Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO
NCT03790852 ·Status: TERMINATED ·Phase: PHASE1
-
A Safety and Efficacy Study of E10030 (Anti-PDGF Pegylated Aptamer) Plus Lucentis for Neovascular Age-Related Macular Degeneration
NCT01089517 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
NCT05859776 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA)
NCT06510816 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3