Safety and Preliminary Efficacy Study of V404 PDS in Uveitis | NCT02125266

Studies
Safety and Preliminary Efficacy Study of V404 PDS in Uveitis

NCT02125266

Sponsor

Forsight Vision4

Status

Terminated

Last Update Posted

Dec 9, 2016Estimated

Enrollment

7Actual

Phase

Phase 1Phase 2

Conditions

Uveitis, Posterior
Uveitis, Intermediate

Interventions

V404

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

Dec 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study terminated due to unacceptable frequency of drug related adverse events

Expanded Access Info

Start Date

Apr 2014

Primary Completion Date

Oct 2014Actual

Completion Date

Mar 2015Actual

First Submitted Date

Apr 24, 2014

First Submission Date that Met QC Criteria

Apr 28, 2014

First Posted Date

Apr 29, 2014Estimated

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

Dec 7, 2016

Certification/Extension First Submitted that Passed QC Review

Dec 7, 2016

Certification/Extension First Posted Date

Dec 9, 2016Estimated

Last Update Submitted Date

Dec 7, 2016

Last Update Posted Date

Dec 9, 2016Estimated

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

Description Module

Brief Summary

This study is intended to evaluate the safety of V404 PDS in patients with chronic non-infectious uveitis. Secondarily, the study will evaluate whether V404 PDS can provide clinically measurable benefit over an extended period of time in patients with chronic non-infectious uveitis.

Detailed Description

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low Dose V404 PDS	Experimental	Sustained intravitreal delivery of methotrexate (0.6 mg)	Drug: V404
High Dose V404 PDS	Experimental	Sustained intravitreal delivery of methotrexate (2.3 mg)	Drug: V404

Interventions

Name	Type	Description	Arm Group Labels	Other Names
V404	Drug	Sustained Release	High Dose V404 PDS Low Dose V404 PDS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency of adverse events		6 months

Secondary Outcomes

Measure	Description	Time Frame
Change in vitreous haze score		Baseline, 6 Months

Other Outcomes

Measure	Description	Time Frame
Change in macular thickness by ocular coherence tomography		Baseline, 6 Months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years of age or older
Confirmed diagnosis of active uveitis
Sufficient lens/media clarity
Meet best-corrected visual acuity criteria
Willing and able to use contraception

Exclusion Criteria:

Pregnant, breast feeding
Uncontrolled glaucoma
Intraocular surgery or periocular/intraocular injections within 6 weeks
Periocular or intraocular steroid within 3 months
Prior vitrectomy
Prior corneal transplant
Prior fluocinolone implant
Allergy or sensitivity to study drug
Participation in other trial within 30 days
Abnormal liver function
History of positive serum tuberculosis test

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Golden	Colorado		United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015866	Uveitis, Posterior
D015867	Uveitis, Intermediate

Ancestor Terms

ID	Term
D015864	Panuveitis
D014605	Uveitis
D014603	Uveal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008727	Methotrexate

Ancestor Terms

ID	Term
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring

Browse Leaves

Not provided

Browse Branches

Not provided