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

Dry Age-related Macular Degeneration Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04065490
• Other study ID #: CSP005
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: February 2021
• Source: LumiThera, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Age-related Macular Degeneration
• Macular Degeneration

Intervention

Device:
• Valeda PBM treatment
The Valeda Light Delivery System
• Valeda Sham treatment
The sham mode of the Valeda Light Delivery System.

Locations

Country	Name	City	State
United States	Florida Eye Clinic	Altamonte Springs	Florida
United States	Retina Vitreous Associates Medical Group	Beverly Hills	California
United States	Cumberland Valley Retina Consultants	Chambersburg	Pennsylvania
United States	Mid Atlantic Retina	Cherry Hill	New Jersey
United States	Duke Eye Center	Durham	North Carolina
United States	Cumberland Valley Retina Consultants	Hagerstown	Maryland
United States	Gulf Coast Eye Institute	McAllen	Texas
United States	New York Ear and Eye Infirmary	New York	New York
United States	Stanford University	Palo Alto	California
United States	Retina Center Northwest	Silverdale	Washington
United States	Retina Consultants of Houston	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
LumiThera, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Contrast Sensitivity	Mean change from baseline (pre-treatment) in contrast sensitivity at 80 cm and 120 cm.	21 Months
Other	Visual Function Questionnaire	Mean change from baseline (pre-treatment) in Visual Function Questionnaire (VFQ-25) composite score.	21 Months
Other	Reading Speed	Mean change from baseline (pre-treatment) to Month 21 in monocular reading speed assessed by the Radner Reading Chart.	21 Months
Other	Geographic Atrophy	Mean change from baseline in the GA lesion area of the PBM treatment group versus the sham treatment group, as measured by FAF.	21 Months
Other	Low Luminance- Best Corrected Visual Acuity	Mean change from baseline in the LLBVCA.	21 Months
Primary	Best Corrected Visual Acuity	Mean change from baseline in BCVA.	21 months
Secondary	Contrast Sensitivity	Mean change from baseline (pre-treatment) in contrast sensitivity at 40 cm.	21 months
Secondary	Central Drusen Volume	Mean change from baseline (pre-treatment) in central Drusen volume.	21 Months
Secondary	Central Drusen Thickness	Mean change from baseline (pre-treatment) in central Drusen thickness.	21 Months