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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01186432

Enrollment

Registered

2010-08-23

Start date

2010-08-31

Completion date

2014-04-30

Last updated

2015-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration

Brief summary

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

Interventions

DRUGPDS 1.0

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in retinal thickness measured by Optical Coherence Tomography	Monthly

Secondary

Measure	Time frame
Change in Best Corrected Visual Acuity	Monthly

Countries

Latvia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026