Active — Not RecruitingNot Applicable

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

United States96 participantsStarted 2019-09-01

Plain-language 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.

Who can participate

Age range50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:
✓. 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.

What they're measuring

Best Corrected Visual Acuity

Timeframe: 21 months

Trial details

NCT IDNCT04065490

SponsorLumiThera, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-01

View on ClinicalTrials.gov More Dry Age-related Macular Degeneration trials