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Safety and Efficacy Study of rAAV.sFlt-1 in Patients With Exudative Age-Related Macular Degeneration

NCT01494805 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-09-01

No results posted yet for this study

Summary

The study will involve approximately 40 subjects aged 55 or above who have exudative age-related macular degeneration (wet AMD). Patients will be randomized to receive one of two doses of rAAV.sFlt-1 or assigned to the control group.

Conditions

  • Macular Degeneration
  • Age-related Maculopathies
  • Age-related Maculopathy
  • Maculopathies,Age-related
  • Maculopathy,Age-related
  • Retinal Degeneration
  • Retinal Neovascularization
  • Eye Diseases

Interventions

BIOLOGICAL

rAAV.sFlt-1

1 x 10\^10 vector genomes (vg) rAAV.sFlt-1, delivered by subretinal injection

BIOLOGICAL

rAAV.sFlt-1

1 x 10\^11 vector genomes (vg) rAAV.sFlt-1, delivered by subretinal injection

OTHER

Control (ranibizumab alone)

Patients will not receive rAAV.sFlt-1, but will be eligible for retreatment with ranibizumab (Lucentis).

Sponsors & Collaborators

  • Adverum Biotechnologies, Inc.

    collaborator INDUSTRY

  • Lions Eye Institute, Perth, Western Australia

    lead OTHER

Principal Investigators

  • Ian Constable, Professor · Lions Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2017-05-31
Completion
2017-08-31

Countries

  • Australia

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 NCT01494805 on ClinicalTrials.gov