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

• ClinicalTrials.gov Identifier: NCT04065490
• Recruitment Status: Active, not recruiting
• First Posted: August 22, 2019
• Last Update Posted: February 5, 2021
• Sponsor: LumiThera, Inc.
• Information provided by (Responsible Party): LumiThera, Inc.

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	Not Applicable

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 (Clinical Trial)
• Estimated Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Valeda 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: September 1, 2019
• Estimated Primary Completion Date: June 1, 2022
• Estimated Study Completion Date: June 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.

Outcome Measures

Primary Outcome Measures :

1. Best Corrected Visual Acuity [ Time Frame: 21 months ]
   Mean change from baseline in BCVA.

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Contrast Sensitivity [ Time Frame: 21 Months ]
   Mean change from baseline (pre-treatment) in contrast sensitivity at 80 cm and 120 cm.
2. Visual Function Questionnaire [ Time Frame: 21 Months ]
   Mean change from baseline (pre-treatment) in Visual Function Questionnaire (VFQ-25) composite score.
3. Reading Speed [ Time Frame: 21 Months ]
   Mean change from baseline (pre-treatment) to Month 21 in monocular reading speed assessed by the Radner Reading Chart.
4. Geographic Atrophy [ Time Frame: 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.
5. Low Luminance- Best Corrected Visual Acuity [ Time Frame: 21 Months ]
   Mean change from baseline in the LLBVCA.

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Male or female at least 50 years of age at Screening visit
2. 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.

3. 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

4. Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
5. Informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines

Exclusion Criteria:

1. Current or history of neovascular maculopathy that includes any of the following (to be confirmed by the reading center):

   1. Choroidal neovascularization (CNV) defined as pathologic angiogenesis originating from the choroidal vasculature that extends through a defect in Bruch's membrane
   2. Serous and/or hemorrhagic detachment of the neurosensory retina or retinal pigment epithelial (RPE)
   3. Retinal hard exudates (a secondary phenomenon resulting from chronic intravascular leakage)
   4. Subretinal and sub-RPE fibrovascular proliferation
   5. Disciform scar (subretinal fibrosis)
2. Presence of center involving GA within the central ETDRS 1 mm diameter at Screening, to be confirmed by the reading center
3. 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.
4. 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.
5. Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three 3 months prior to Screening
6. Ocular disorder or disease that partially or completely obstructs the pupil (e.g. posterior synechia in uveitis)
7. 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)
8. 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)
9. Presence or history of disease or condition affecting functional vision without obvious structural abnormalities (e.g. amblyopia, stroke, nystagmus)
10. 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
11. 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
12. Is non-ambulatory
13. 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)
14. Use of any photosensitizing agent (e.g. topicals, injectables, oral) within 30 days of treatment without consulting subject's physician
15. History of drug, alcohol or substance abuse within 3 months prior to Screening
16. Has received an investigational drug or treatment with an investigational device within 3 months prior to Screening
17. 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.
18. Has received Low Vision Rehab/Therapy within 30 days prior to Screening or intends to receive during the study
19. 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.
20. In the opinion of the Investigator, is unlikely to comply with the study protocol

Contacts and Locations

Locations

United States, California

Retina Vitreous Associates Medical Group

Beverly Hills, California, United States, 90211

Stanford University

Palo Alto, California, United States, 94303

United States, Florida

Florida Eye Clinic

Altamonte Springs, Florida, United States, 32701

United States, Maryland

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States, 21749

United States, New Jersey

Mid Atlantic Retina

Cherry Hill, New Jersey, United States, 19107

United States, New York

New York Ear and Eye Infirmary

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

United States, North Carolina

Duke Eye Center

Durham, North Carolina, United States, 27705

United States, Pennsylvania

Cumberland Valley Retina Consultants

Chambersburg, Pennsylvania, United States, 17201

United States, Texas

Gulf Coast Eye Institute

McAllen, Texas, United States, 78503

Retina Consultants of Houston

The Woodlands, Texas, United States, 77384

United States, Washington

Retina Center Northwest

Silverdale, Washington, United States, 98383

Sponsors and Collaborators

LumiThera, Inc.

More Information

• Responsible Party: LumiThera, Inc.
• ClinicalTrials.gov Identifier: NCT04065490
• Other Study ID Numbers: CSP005
• First Posted: August 22, 2019
• Last Update Posted: February 5, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by LumiThera, Inc.:

Dry age-related macular degeneration; Photobiomodulation; Visual Acuity; Contrast Sensitivity; Drusen; Optical coherence tomography

Additional relevant MeSH terms:

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases