Safety and Preliminary Efficacy Study of PDS-1.0 in Patie... | NCT01177644

Studies
Safety and Preliminary Efficacy Study of PDS-1.0 in Patients With Neovascular AMD

NCT01177644

Sponsor

Forsight Vision4

Status

Withdrawn

Last Update Posted

Aug 22, 2012Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Age-Related Macular Degeneration

Interventions

PDS 1.0

Countries

Israel

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

Aug 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jul 2011Estimated

Completion Date

Not provided

First Submitted Date

Aug 5, 2010

First Submission Date that Met QC Criteria

Aug 5, 2010

First Posted Date

Aug 9, 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

Aug 21, 2012

Last Update Posted Date

Aug 22, 2012Estimated

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
Active	Experimental		Drug: PDS 1.0

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

Key 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 20/80 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