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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Forsight Vision4
ClinicalTrials.gov Identifier:
NCT01186432
First received: August 19, 2010
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Age-Related Macular Degeneration
Drug: PDS 1.0
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Forsight Vision4:

Primary Outcome Measures:
  • Change in retinal thickness measured by Optical Coherence Tomography [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Best Corrected Visual Acuity [ Time Frame: Monthly ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: August 2010
Estimated Study Completion Date: May 2014
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: PDS 1.0

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186432

Locations
Latvia
Riga, Latvia
Sponsors and Collaborators
Forsight Vision4
  More Information

No publications provided

Responsible Party: Forsight Vision4
ClinicalTrials.gov Identifier: NCT01186432     History of Changes
Other Study ID Numbers: FSV4 FH-1.2
Study First Received: August 19, 2010
Last Updated: April 7, 2014
Health Authority: Latvia: State Agency of Medicines

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 21, 2014