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Safety and Tolerability Study of AAV2-sFLT01 in Patients With Neovascular Age-Related Macular Degeneration (AMD)

NCT01024998 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2018-08-22

No results posted yet for this study

Summary

This Phase 1 clinical research study will examine the safety and tolerability of an experimental gene transfer agent, AAV2-sFLT01, in patients with Neovascular Age-Related Macular Degeneration (AMD).

Conditions

  • Macular Degeneration
  • Age-Related Maculopathies
  • Age-Related Maculopathy
  • Maculopathies, Age-Related
  • Maculopathy, Age-Related
  • Retinal Degeneration
  • Retinal Neovascularization
  • Gene Therapy
  • Therapy, Gene
  • Eye Diseases

Interventions

BIOLOGICAL

AAV2-sFLT01

2 x 10\^8 vector genomes (vg) AAV2-sFLT01. Single intravitreal injection to a single eye, using a fixed volume of 100 μL.

BIOLOGICAL

AAV2-sFLT01

2 x 10\^9 vector genomes (vg) AAV2-sFLT01. Single intravitreal injection to a single eye, using a fixed volume of 100 μL.

BIOLOGICAL

AAV2-sFLT01

6 x 10\^9 vector genomes (vg) AAV2-sFLT01. Single intravitreal injection to a single eye, using a fixed volume of 100 μL.

BIOLOGICAL

AAV2-sFLT01

2 x 10\^10 vector genomes (vg) AAV2-sFLT01. Single intravitreal injection to a single eye, using a fixed volume of 100 μL.

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-11
Primary Completion
2014-07-31
Completion
2018-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01024998 on ClinicalTrials.gov