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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014