NCT04065490

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 5, 2021

Status Verified

February 1, 2021

Enrollment Period

2.8 years

First QC Date

August 16, 2019

Last Update Submit

February 4, 2021

Conditions

Dry Age-related Macular Degeneration

Keywords

Dry age-related macular degenerationPhotobiomodulationVisual AcuityContrast SensitivityDrusenOptical coherence tomography

Outcome Measures

Primary Outcomes (1)

  • Best Corrected Visual Acuity

    Mean change from baseline in BCVA.

    21 months

Secondary Outcomes (3)

  • Contrast Sensitivity

    21 months

  • Central Drusen Volume

    21 Months

  • Central Drusen Thickness

    21 Months

Other Outcomes (5)

  • Contrast Sensitivity

    21 Months

  • Visual Function Questionnaire

    21 Months

  • Reading Speed

    21 Months

  • +2 more other outcomes

Study Arms (2)

PBM Treatment

EXPERIMENTAL

The Valeda™ Light Delivery System

Device: Valeda PBM treatment

Sham Treatment

SHAM COMPARATOR

The Valeda™ Light Delivery System non-effective treatment

Device: Valeda Sham treatment

Interventions

Valeda PBM treatmentDEVICE

The Valeda Light Delivery System

PBM Treatment
Valeda Sham treatmentDEVICE

The sham mode of the Valeda Light Delivery System.

Sham Treatment

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female at least 50 years of age at Screening visit
  • ETDRS BCVA letter score of between 50\* and 75\* (Snellen equivalent of 20/100 to 20/32). \*If the subject meets this criterion at the Screening Visit, but the Baseline BCVA letter score is between 48 and 77, the subject may be entered in the study.
  • Diagnosis of dry AMD as defined by the presence of the following:
  • Drusen that are intermediate in size or larger (63 μm or larger in diameter) with at least a few (3) being regular drusen and not pseudodrusen and/or geographic atrophy (GA) visible on two of the following: color fundus images, OCT and/or FAF, to be confirmed by the reading center
  • Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
  • Informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines

You may not qualify if:

  • Current or history of neovascular maculopathy that includes any of the following (to be confirmed by the reading center):
  • Choroidal neovascularization (CNV) defined as pathologic angiogenesis originating from the choroidal vasculature that extends through a defect in Bruch's membrane
  • Serous and/or hemorrhagic detachment of the neurosensory retina or retinal pigment epithelial (RPE)
  • Retinal hard exudates (a secondary phenomenon resulting from chronic intravascular leakage)
  • Subretinal and sub-RPE fibrovascular proliferation
  • Disciform scar (subretinal fibrosis)
  • Presence of center involving GA within the central ETDRS 1 mm diameter at Screening, to be confirmed by the reading center
  • Media opacities, including cataracts, which might interfere with visual acuity or imaging in the study eye(s). Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye in the next 24 months.
  • Posterior capsule opacification, which might interfere with visual acuity or imaging in the study eye(s). Subjects should not be entered if there is likelihood that they will require surgery in the study eye in the next 24 months.
  • Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three 3 months prior to Screening
  • Ocular disorder or disease that partially or completely obstructs the pupil (e.g. posterior synechia in uveitis)
  • Visually significant disease in any ocular structure apart from dry AMD (e.g. diabetic macular edema, glaucoma (using \>2 eye drop medications, uncontrolled IOP and/or central/paracentral visual field loss), glaucoma surgery, active uveitis, active vitreous disease, intraocular tumor, retinal vascular diseases)
  • Ocular disorder or disease other than dry AMD that could cause drusen (glomerulonephritis Type 2, Autosomal dominant drusen), GA (North Carolina dystrophy) or mitochondrial diseases (parafoveal petaloid GA, Stargardt disease)
  • Presence or history of disease or condition affecting functional vision without obvious structural abnormalities (e.g. amblyopia, stroke, nystagmus)
  • Serious medical illness that will prevent the subject from performing study activities (including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease) or, in the judgement of the Investigator, is likely to require surgical intervention or hospitalization at any point during the study
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Retina Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Stanford University

Palo Alto, California, 94303, United States

Location

Florida Eye Clinic

Altamonte Springs, Florida, 32701, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21749, United States

Location

Mid Atlantic Retina

Cherry Hill, New Jersey, 19107, United States

Location

New York Ear and Eye Infirmary

New York, New York, 10003-4284, United States

Location

Duke Eye Center

Durham, North Carolina, 27705, United States

Location

Cumberland Valley Retina Consultants

Chambersburg, Pennsylvania, 17201, United States

Location

Gulf Coast Eye Institute

McAllen, Texas, 78503, United States

Location

Retina Consultants of Houston

The Woodlands, Texas, 77384, United States

Location

Retina Center Northwest

Silverdale, Washington, 98383, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Valeda Light Delivery System
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2019

First Posted

August 22, 2019

Study Start

September 1, 2019

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

February 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(11)