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

NCT ID: NCT01177644

Last Updated: 2012-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Brief Summary

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This study will evaluate the safety and preliminary effectiveness of PDS 1.0 in patients with neovascular AMD.

Detailed Description

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Conditions

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Age-Related Macular Degeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active

Group Type EXPERIMENTAL

PDS 1.0

Intervention Type DRUG

Interventions

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PDS 1.0

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forsight Vision4

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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FSV4 FH-1

Identifier Type: -

Identifier Source: org_study_id