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

Plain-language summary

This Phase 1 study evaluates, at increasing doses, the safety of RetinoStat, a gene therapy injected into the eye, in patients with advanced age-related macular degeneration (AMD). It included AMD patients with active leaking blood vessels and visual acuity below a certain level. It was carried out in Phase 1 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Completed

Sponsor

Oxford BioMedica

Intervention

Subretinally injected RetinoStat

Start date

2/1/2011

Estimated completion

5/1/2015

Countries

United States

Related genes

Locations

• Iowa City, United States
• Baltimore, United States
• Portland, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.