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OpenTrials
Completed

NCT Number: NCT01186432

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

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

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Riga, Latvia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

PDS 1.0

Drug

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

Sponsors and collaborators

Lead sponsor

Forsight Vision4

Industry

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Aug 23, 2010
Registry last updated
Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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