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

ForSight VISION4

Status and phase: Completed; Phase 1

Conditions: Age-Related Macular Degeneration

Treatments: Drug: PDS 1.0

Study type: Interventional

Funder types: Industry

Identifiers

NCT01186432

FSV4 FH-1.2

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Active

Experimental group

Description:

ranibizumab sustained delivery implant

Treatment:

Drug: PDS 1.0