Trial Search Results

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

LumiThera, Inc.

Stanford Investigator(s):

Intervention(s):

  • Device: Valeda PBM treatment
  • Device: Valeda Sham treatment

Phase:

N/A

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

Ages Eligible for Study

50 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting