Phase I Dose Escalation Safety Study of RetinoStat in Advanced Age-Related Macular Degeneration (AMD)

Completed · Phase 1

Conditions studied: Age Related Macular Degeneration

In brief

The purpose of this first in man study is to examine the safety of an experimental gene transfer agent, RetinoStat, designed to treat neovascular age-related macular degeneration.

Key facts

Study ID

NCT01301443

Run by

Oxford BioMedica

People needed

21

Starts

2011-02-01

Expected to finish

2015-05-01

Last updated by the study team

2017-04-05

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of AMD with active CNV that shows evidence of leakage.
• BCVA less than or equal to 20/200 in the study eye for dose escalation phase.
• BCVA less than or equal to 20/80 in the study eye for maximum tolerated dose phase.

You may not qualify if…

• Significant ocular abnormalities that prevent retinal assessment.
• Treatment with steroids within three months of screening.
• Treatment with anti-VEGF therapy to either eye within one month of screening.
• Clinically significant intercurrent illnesses, laboratory, ECG or chest XRay abnormalities.

Where it is running

• The University of Iowa — Iowa City, Iowa, United States
• Johns Hopkins University Hospital — Baltimore, Maryland, United States
• Dr Andreas Lauer - Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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