A Phase I Open Label Dose Escalation Trial of RNA-144101... | NCT01093170

Studies
A Phase I Open Label Dose Escalation Trial of RNA-144101 in the Treatment of Geographic Atrophy

NCT01093170

Sponsor

Mark Kleinman

Status

Withdrawn

Last Update Posted

Jan 17, 2018Actual

Enrollment

0Actual

Phase

Phase 1

Conditions

Geographic Atrophy

Interventions

RNA-144101

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was not conducted, no subjects recruited.

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Mar 22, 2010

First Submission Date that Met QC Criteria

Mar 24, 2010

First Posted Date

Mar 25, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2018

Last Update Posted Date

Jan 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Label	Type	Description	Intervention Names
RNA-144101	Experimental		Drug: RNA-144101

Name	Type	Description	Arm Group Labels	Other Names
RNA-144101	Drug	Intravitreous administration of RNA-144101	RNA-144101

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability of RNA-144101 as measured by vision testing, ophthalmic and physical exams, vital signs, clinical laboratory testing and AEs.		Through study completion or discontinuation

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic studies measuring drug concentrations in serum over study period.		Through study completion or discontinuation
Measurement of total aggregate area of GA lesions (as determined by color fundus photography and autofluorescence imaging)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females of all races and ethnicities between the ages of 50-99
Female subjects must be 1-year postmenopausal or surgically sterilized and must have negative serum pregnancy test
Subjects must have GA from AMD in one or both eyes:
The study eye will be the eye that meets all inclusion/exclusion criteria
If both eyes meet criteria, then the eye with the smaller GA lesion will be studied
If the GA lesions are equal in size, then the eye with the best-corrected visual acuity (BCVA) will chosen as the study eye
If both eyes have the same lesion size and same BCVA, the right eye will be chosen
Subjects must have the following GA criteria for inclusion:
GA lesions with an area > 2.5mm2 and ≤ 20mm2 as determine by fluorescein angiography and fundus autofluorescence
A clear view to the fundus must be present in order to easily examine the study eye at baseline
BCVA In the study eye between 20/20 and 20/100 as measured on Snellen chart or 85-50 letters by ETDRS
Willing and able to provide signed informed consent prior to any study participation

Exclusion Criteria:

GA due to a disease other than AMD
Pregnancy or lactation
Treatment of any systemic infection
Autofluorescence pattern marked at none, focal or patchy
Ocular surgery in the study eye in the previous 6 months.
Presence or history of choroidal neovascularization (wet AMD) in the study eye
Any inflammatory (autoimmune, uveitis) or neovascular (diabetic retinopathy) disease of the retina
Any history of glaucoma or disc cupping in the study eye
Any history of severe dry eye disease
High myopia > - 8D or high hyperopia > +8D in the study eye
Presence of life-threatening disease
Abnormal basal metabolic panel or liver function tests
Current alcohol or other substance abuse
Unwilling or unable to provide signed informed consent for any study procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases