NCT01186432

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

August 19, 2010

Last Update Submit

March 4, 2015

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

ranibizumab sustained delivery implant

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 20/40 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

Riga, Latvia

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

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 19, 2010

First Posted

August 23, 2010

Study Start

August 1, 2010

Primary Completion

May 1, 2012

Study Completion

April 1, 2014

Last Updated

March 5, 2015

Record last verified: 2015-03

Locations

LA(1)