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CompletedNCT01186432Updated Mar 5, 2015

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

A Phase 1 interventional study of PDS 1.0 in Age-Related Macular Degeneration, sponsored by Forsight Vision4. Completed at 1 site in Latvia. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2015-03-05.

Sponsored by Forsight Vision4 · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Age-Related Macular Degeneration
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 20 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Forsight Vision4 is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Evidence of scarring CNV (e.g. geographic atrophy) in the study eye
  • Fibrosis >75% of lesion area in the study eye
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Active

    ranibizumab sustained delivery implant

    Drug: PDS 1.0

Interventions

  • DrugPDS 1.0
06

What researchers measure

Primary outcomes

  1. Change in retinal thickness measured by Optical Coherence Tomography

    Time frame: Monthly

Secondary outcomes

  1. Change in Best Corrected Visual Acuity

    Time frame: Monthly

07

Study locations

1 site
  • Riga, Latvia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01186432
Lead sponsor
Forsight Vision4
Responsible party
Sponsor
First posted
Aug 23, 2010
Start date
Aug 2010
Primary completion
May 2012
Completion
Apr 2014
Last update
Mar 5, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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