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RO6867461

Phase 1

Macular Degeneration | Small molecule | Ophthalmology |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

RO6867461 · 1 trial · 1 indication

Phase 1 1
NCT01941082A Study of RO6867461 Administered in Single- and Multiple-Ascending Doses in Patients With Wet Age-Related Macular DegenerationMacular Degeneration
COMPLETED24 Analytics
PHASE1COMPLETED
A Study of RO6867461 Administered in Single- and Multiple-Ascending Doses in Patients With Wet Age-Related Macular Degeneration
Macular DegenerationUnlock trial analytics

Study Endpoints

Primary Endpoints

Ocular safety, assessed by BCVA (EDTRS chart), slitlamp examination, ophthalmoscopy, IOP, fundus photography, SD-OCT, angiography
Part A, 12 weeks; Part B, 20 weeks
Safety: Incidence of adverse events
Part A, 12 weeks; Part B, 20 weeks

Secondary Endpoints

Pharmacokinetics: Area under the concentration time curve (AUC)
Part A, 12 weeks; Part B, 20 weeks
Pharmacokinetics: Maximum plasma concentration (Cmax)
Part A, 12 weeks; Part B, 20 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: RO6867461EXPERIMENTALSingle doses
Part B: RO6867461EXPERIMENTALMultiple doses

Interventions

NameTypeDescription
RO6867461DRUGSingle or multiple ascending dose by intravitreal injection
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Adult patients, \>/= 50 years of age * Patients with age-related macular degeneration (AMD) * Best corrected visual acuity (BCVA) of 20/40 to 20/400 (Snellen equivalent, on ETDRA charts) inclusive * Evidence of leakage due to choroidal neovascularization (CNV) Exclusion Crite...

Countries:United StatesUnited Kingdom
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Frequently asked questions about RO6867461

What is RO6867461 used for?

RO6867461 is an investigational small molecule being studied for the treatment of macular degeneration, specifically wet age-related macular degeneration. It is administered in single and multiple ascending doses to patients with this condition. The drug is currently in Phase 1 clinical development.

Who makes RO6867461?

RO6867461 is being developed by Roche Holding AG, a company traded under the ticker RHHBY. Roche is conducting clinical trials to evaluate the safety and tolerability of this investigational drug in patients with wet age-related macular degeneration.

What phase is RO6867461 in?

RO6867461 is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the drug in single and multiple ascending doses in patients with wet age-related macular degeneration. The drug is investigational and not yet approved for any use.

What clinical trials is RO6867461 in?

RO6867461 has one completed clinical trial, identified as NCT01941082. This Phase 1 study evaluated single and multiple ascending doses of the drug in patients with wet age-related macular degeneration. The trial enrolled 24 participants and was conducted in the United States and United Kingdom.

Is RO6867461 FDA approved?

RO6867461 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for wet age-related macular degeneration. A Phase 1 trial has been completed, but the drug has not yet received regulatory approval for any indication.