Preliminary Safety and Efficacy of the PDS-1.0 in Patient... | NCT01186432

Studies
Preliminary Safety and Efficacy of the PDS-1.0 in Patients With Neovascular Age Related Macular Degeneration (AMD)

NCT01186432

Sponsor

Forsight Vision4

Status

Completed

Last Update Posted

Mar 5, 2015Estimated

Enrollment

20Actual

Phase

Phase 1

Conditions

Age-Related Macular Degeneration

Interventions

PDS 1.0

Countries

Latvia

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

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

May 2012Actual

Completion Date

Apr 2014Actual

First Submitted Date

Aug 19, 2010

First Submission Date that Met QC Criteria

Aug 20, 2010

First Posted Date

Aug 23, 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

Mar 4, 2015

Last Update Posted Date

Mar 5, 2015Estimated

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active	Experimental	ranibizumab sustained delivery implant	Drug: PDS 1.0

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PDS 1.0	Drug		Active

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in retinal thickness measured by Optical Coherence Tomography		Monthly

Secondary Outcomes

Measure	Description	Time Frame
Change in Best Corrected Visual Acuity		Monthly

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of CNV secondary to AMD confirmed by fluorescein angiography, not previously treated
Retinal thickness due to edema of at least 300um in the study eye
Best corrected visual acuity of 20/40 or worse in the study eye
Best corrected visual acuity of 20/40 or better in the fellow eye

Exclusion Criteria:

Evidence of scarring CNV (e.g. geographic atrophy) in the study eye
Fibrosis >75% of lesion area in the study eye

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

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided