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RBM-007 Injectable

Phase 1

Age-related Macular Degeneration | Small molecule | Ophthalmology |BrainsWay Ltd.|Last Updated: Jan 5, 2021

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

RBM-007 Injectable · 1 trial · 1 indication

Phase 1 1
NCT03633084RBM-007 in Subjects witH ExudatIve Age-related Macular DegenerationAge-related Macular Degeneration
COMPLETED9 Analytics
PHASE1COMPLETED
RBM-007 in Subjects witH ExudatIve Age-related Macular Degeneration
Age-related Macular DegenerationUnlock trial analytics

Study Endpoints

Primary Endpoints

Ocular Safety as Assessed Using Biomicroscopy to Investigate Ocular Tolerability
Day 56

Biomicroscopy is used by an ophthalmologist to assess the health of the front of the eye. The measure is the number of subjects with abnormal findings that were not present at screening.

Ocular Safety as Assessed Using Ophthalmoscopy to Investigate Ocular Tolerability
Day 56

Ophthalmoscopy is used by an ophthalmologist to assess the health of the back of the eye. The measure is the number of subjects with abnormal findings that were not present at screening.

Secondary Endpoints

Ocular Tolerability as Assessed by Number and Nature of Adverse Events
Day 56
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RBM-007 Injectable Solution - 0.2 mgEXPERIMENTALNo additional information.
RBM-007 Injectable Solution - 1.0 mgEXPERIMENTALNo additional information.
RBM-007 Injectable Solution - 2.0 mgEXPERIMENTALNo additional information.

Interventions

NameTypeDescription
RBM-007 Injectable SolutionDRUG(No additional description)
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Eligibility Criteria

Age Range55 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Male or female 55 years of age or older on the date of signing the informed consent form and able and willing to comply with all treatment and follow-up study procedures. 2. At Screening Visit, subjects must meet all the following inclusion criteria: 3. Must have had prior tr...

Countries:United States
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Frequently asked questions about RBM-007 Injectable

What is RBM-007 Injectable used for?

RBM-007 Injectable is an investigational small molecule being developed for the treatment of Age-related Macular Degeneration (AMD), specifically exudative AMD. It is administered via injection and is currently in Phase 1 clinical development.

Who makes RBM-007 Injectable?

RBM-007 Injectable is being developed by BrainsWay Ltd. (NASDAQ: BWAY). The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for Age-related Macular Degeneration.

What phase is RBM-007 Injectable in?

RBM-007 Injectable is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational, meaning it has not yet been approved by regulatory authorities for commercial use.

What clinical trials is RBM-007 Injectable in?

RBM-007 Injectable has been studied in one completed Phase 1 clinical trial, NCT03633084, titled 'RBM-007 in Subjects witH ExudatIve Age-related Macular Degeneration.' This trial enrolled 9 participants in the United States and included patients aged 55 years and older.

Is RBM-007 Injectable the same as RBM-007?

Yes, RBM-007 Injectable is the same drug as RBM-007. The name 'RBM-007 Injectable' specifies the route of administration, while 'RBM-007' is the core drug name used in clinical trial documentation.