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RO7171009

Phase 1

Geographic Atrophy | Small molecule | Ophthalmology |Roche Holding AG|Last Updated: Feb 12, 2020

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

RO7171009 · 1 trial · 1 indication

Phase 1 1
NCT03295877Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)Geographic Atrophy
COMPLETED28 Analytics
PHASE1COMPLETED
Safety and Tolerability Study of RO7171009 in Participants With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
Geographic AtrophyUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability of the Study Drug: Rate of Adverse Events
Through study completion or early study discontinuation (overall 12-20 weeks)

Secondary Endpoints

Serum Concentration of RO7171009
Through study completion or early study discontinuation (overall 12-20 weeks)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RO7171009: SADEXPERIMENTALPatients will receive a single dose of RO7171009, in multiple escalating cohorts.
RO7171009: MDEXPERIMENTALPatients will receive RO7171009 at maximum tolerated dose (MTD), identified during the SAD stage for three doses.

Interventions

NameTypeDescription
RO7171009DRUGPatients will receive RO7171009 via ITV injection.
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Participants aged greater than or equal to (\>/=) 50 years * Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in study eye Exclusion Criteria: Ocular Exclusion Criteria, Study Eye: * History of vitrectomy ...

Countries:United States
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Frequently asked questions about RO7171009

What is RO7171009 used for?

RO7171009 is an investigational small molecule being studied for the treatment of geographic atrophy, a form of age-related macular degeneration. It is being developed by Roche Holding AG and is currently in Phase 1 clinical development.

What does RO7171009 target?

The specific molecular target of RO7171009 has not been disclosed. It is a small molecule being investigated for its potential to treat geographic atrophy, a condition that causes progressive vision loss.

Who makes RO7171009?

RO7171009 is being developed by Roche Holding AG, a pharmaceutical company traded on the OTC market under the ticker symbol RHHBY. The drug is currently in Phase 1 clinical development for geographic atrophy.

What phase is RO7171009 in?

RO7171009 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed to evaluate its safety and tolerability.

What clinical trials is RO7171009 in?

RO7171009 has one completed Phase 1 clinical trial, identified as NCT03295877. This study evaluated the safety and tolerability of RO7171009 in participants with geographic atrophy secondary to age-related macular degeneration. The trial enrolled 28 participants in the United States.