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NCT04065490 · ClinicalTrials.gov registry record · NA

Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE III)

A NA study of Dry Age-Related Macular Degeneration, sponsored by LumiThera.

Active
Registry status
NA
Development phase
96
Enrollment target
11
Study locations

NCT04065490: Active NA study of Dry Age-Related Macular Degeneration, sponsored by LumiThera.

NCT04065490 is a NA study of Dry Age-Related Macular Degeneration that is active but no longer recruiting, run by LumiThera. The registered enrollment target is 96 participants, above the 70-participant average among 7 other Dry Age-Related Macular Degeneration trials with a reported enrollment target (37% higher). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04065490, a NA study of Dry Age-Related Macular Degeneration, is active but no longer recruiting, sponsored by LumiThera.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
96 participants
Enrollment target
11
Study locations

Study Summary

This LIGHTSITE III study is a double-masked, sham-controlled, parallel design, prospective multi-site study for the use of PBM as a treatment for visual impairment in subjects with dry AMD.

Primary Outcome

Mean change from baseline in BCVA.

Interventions

  • DEVICE Valeda PBM treatment
  • DEVICE Valeda Sham treatment

Study Locations (11)

California

  • Retina Vitreous Associates Medical Group - Beverly Hills
  • Stanford University - Palo Alto

Texas

  • Gulf Coast Eye Institute - McAllen
  • Retina Consultants of Houston - The Woodlands

Florida

  • Florida Eye Clinic - Altamonte Springs

Maryland

  • Cumberland Valley Retina Consultants - Hagerstown

New Jersey

  • Mid Atlantic Retina - Cherry Hill

New York

  • New York Ear and Eye Infirmary - New York

North Carolina

  • Duke Eye Center - Durham

Pennsylvania

  • Cumberland Valley Retina Consultants - Chambersburg

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2019-09-01
Est. Completion 2022-06-01
Phase NA
LumiThera

3 total trials

What the registry record for NCT04065490 still lists

NCT04065490 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, above the 70-participant average among 7 other Dry Age-Related Macular Degeneration trials with a reported enrollment target (37% higher).

The record links to 1 condition, with Dry Age-Related Macular Degeneration appearing as the primary indexed condition, and to 2 interventions - of which Valeda PBM treatment is the first listed.

NCT04065490 lists 11 locations in 9 states (California, Texas, Florida).

Frequently Asked Questions

What is clinical trial NCT04065490 about?

NCT04065490 is a clinical study titled "Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE III)". This LIGHTSITE III study is a double-masked, sham-controlled, parallel design, prospective multi-site study for the use of PBM as a treatment for visual impairment in subjects with dry AMD.

What is the current status of trial NCT04065490?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 96 participants. The study started on 2019-09-01. Estimated completion is 2022-06-01.

What conditions does trial NCT04065490 study?

This clinical trial studies the following conditions: Dry Age-Related Macular Degeneration.

What interventions are being tested in trial NCT04065490?

The interventions under investigation include: Valeda PBM treatment (DEVICE), Valeda Sham treatment (DEVICE).

Who is sponsoring clinical trial NCT04065490?

This trial is sponsored by LumiThera, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04065490 being conducted?

This trial has 11 study locations across California, Florida, Maryland, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT04065490, the US trial registry maintained by the National Library of Medicine. NCT04065490 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.