NCT01177644

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Last Updated

August 22, 2012

Status Verified

August 1, 2012

Enrollment Period

6 months

First QC Date

August 5, 2010

Last Update Submit

August 21, 2012

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Change in retinal thickness measured by Optical Coherence Tomography

    Monthly

Secondary Outcomes (1)

  • Change in Best Corrected Visual Acuity

    Monthly

Study Arms (1)

Active

EXPERIMENTAL
Drug: PDS 1.0

Interventions

PDS 1.0DRUG
Active

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2010

First Posted

August 9, 2010

Study Start

January 1, 2011

Primary Completion

July 1, 2011

Last Updated

August 22, 2012

Record last verified: 2012-08

Locations

IL(1)