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

Sponsor

LumiThera, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04065490

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

8.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Age-related Macular Degeneration	Device: Valeda PBM treatment Device: Valeda Sham treatment	N/A

Detailed Description

This study is a double-masked, sham-controlled, parallel design prospective, multi-site study on the use of photobiomodulation (PBM) as a treatment for visual impairment in subjects with dry AMD. Subjects will receive repeated sham or PBM treatments at several time-points throughout the 2-year study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Valeda Light Delivery SystemValeda Light Delivery System

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Double-Masked, Randomized, Sham-Controlled, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Photobiomodulation (PBM) in Subjects With Dry Age-Related Macular Degeneration (AMD) (LIGHTSITE III)

Actual Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PBM Treatment The Valeda™ Light Delivery System	Device: Valeda PBM treatment The Valeda Light Delivery System
Sham Comparator: Sham Treatment The Valeda™ Light Delivery System non-effective treatment	Device: Valeda Sham treatment The sham mode of the Valeda Light Delivery System.

Arm

Intervention/Treatment

Experimental: PBM Treatment

The Valeda™ Light Delivery System

Device: Valeda PBM treatment

The Valeda Light Delivery System

Sham Comparator: Sham Treatment

The Valeda™ Light Delivery System non-effective treatment

Device: Valeda Sham treatment

The sham mode of the Valeda Light Delivery System.

Outcome Measures

Primary Outcome Measures

Best Corrected Visual Acuity [21 months]
Mean change from baseline in BCVA.

Secondary Outcome Measures

Contrast Sensitivity [21 months]
Mean change from baseline (pre-treatment) in contrast sensitivity at 40 cm.
Central Drusen Volume [21 Months]
Mean change from baseline (pre-treatment) in central Drusen volume.
Central Drusen Thickness [21 Months]
Mean change from baseline (pre-treatment) in central Drusen thickness.

Other Outcome Measures

Contrast Sensitivity [21 Months]
Mean change from baseline (pre-treatment) in contrast sensitivity at 80 cm and 120 cm.
Visual Function Questionnaire [21 Months]
Mean change from baseline (pre-treatment) in Visual Function Questionnaire (VFQ-25) composite score.
Reading Speed [21 Months]
Mean change from baseline (pre-treatment) to Month 21 in monocular reading speed assessed by the Radner Reading Chart.
Geographic Atrophy [21 Months]
Mean change from baseline in the GA lesion area of the PBM treatment group versus the sham treatment group, as measured by FAF.
Low Luminance- Best Corrected Visual Acuity [21 Months]
Mean change from baseline in the LLBVCA.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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
Presence of or history of malignancy within the past 5 years other than non-melanoma skin or squamous cell cancer or cervical carcinoma in-situ
Is non-ambulatory
Presence or history of known light sensitivity to yellow light, red light, or near infrared radiation (NIR), or if they have a history of light activated CNS disorders (e.g. epilepsy, migraine)
Use of any photosensitizing agent (e.g. topicals, injectables, oral) within 30 days of treatment without consulting subject's physician
History of drug, alcohol or substance abuse within 3 months prior to Screening
Has received an investigational drug or treatment with an investigational device within 3 months prior to Screening
If on any anti-oxidant or vitamin Age-Related Eye Disease Study (AREDS) supplement for dry AMD, has not been stabilized for a minimum of 1 month prior to Screening. Subjects are considered to be stable if they are taking the AREDS supplements consistently as prescribed by their treating doctor.
Has received Low Vision Rehab/Therapy within 30 days prior to Screening or intends to receive during the study
Has an open sore(s) that may come in contact with the Valeda System, has periorbital skin erythema or is prone to such conditions with exposure to light.
In the opinion of the Investigator, is unlikely to comply with the study protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina Vitreous Associates Medical Group	Beverly Hills	California	United States	90211
2	Stanford University	Palo Alto	California	United States	94303
3	Florida Eye Clinic	Altamonte Springs	Florida	United States	32701
4	Cumberland Valley Retina Consultants	Hagerstown	Maryland	United States	21749
5	Mid Atlantic Retina	Cherry Hill	New Jersey	United States	19107
6	New York Ear and Eye Infirmary	New York	New York	United States	10003-4284
7	Duke Eye Center	Durham	North Carolina	United States	27705
8	Cumberland Valley Retina Consultants	Chambersburg	Pennsylvania	United States	17201
9	Gulf Coast Eye Institute	McAllen	Texas	United States	78503
10	Retina Consultants of Houston	The Woodlands	Texas	United States	77384
11	Retina Center Northwest	Silverdale	Washington	United States	98383