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Episcleral Brachytherapy for the Treatment of Wet AMD

NCT02988895 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-08-30

No results posted yet for this study

Summary

This is a prospective, multi-site, safety and feasibility study of the SalutarisMD SMD-DA system for retrobulbar minimally invasive episcleral brachytherapy device in patients receiving and not responding to anti-VEGF therapy for nAMD. The trial will be open label and non-randomized. The study intervention is a one-time intervention and requires no alteration to the standard of care during the follow-up period.

Conditions

  • Macular Degeneration, Choroidal Neovascularization

Interventions

RADIATION

episcleral brachytherapy

The study intervention is an outpatient, ambulatory procedure performed under local anesthesia with anesthesia assist.

Sponsors & Collaborators

  • Salutaris Medical Devices, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2023-05-26
Completion
2025-05-31
FDA Device
Yes

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 NCT02988895 on ClinicalTrials.gov