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NCT03878420
Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE II)
NA trial testing Valeda PBM treatment in Dry Age-related Macular Degeneration in 44 participants. Completed in 22 January 2021.
22 January 2021
Quick facts
| Lead sponsor | LumiThera, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 44 |
| Start date | 14 February 2019 |
| Primary completion | 22 January 2021 |
| Estimated completion | 22 January 2021 |
| Sites | 8 locations across France, Italy, United Kingdom, Germany, Spain |
Drugs / interventions tested
- Valeda PBM treatment
- Valeda Sham treatment
Conditions studied
- Dry Age-related Macular Degeneration — all drugs for Dry Age-related Macular Degeneration →
Sponsor
LumiThera, Inc.
Who can join
Adults 50 to 120, any sex, with Dry Age-related Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This LIGHTSITE II 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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Mitochondrial Defects Drive Degenerative Retinal Diseases.
Ferrington DA, Fisher CR, Kowluru RA. · · 2020 · cited 123× · PMID 31771932 · DOI 10.1016/j.molmed.2019.10.008 -
LIGHTSITE II Randomized Multicenter Trial: Evaluation of Multiwavelength Photobiomodulation in Non-exudative Age-Related Macular Degeneration.
Burton B, Parodi MB, Jürgens I, Zanlonghi X, et al · · 2023 · cited 36× · PMID 36588113 · DOI 10.1007/s40123-022-00640-6 -
Photobiomodulation Therapy for Age-Related Macular Degeneration and Diabetic Retinopathy: A Review.
Muste JC, Russell MW, Singh RP. · · 2021 · cited 21× · PMID 34511875 · DOI 10.2147/opth.s272327 -
The Present and Future of Mitochondrial-Based Therapeutics for Eye Disease.
Ji MH, Kreymerman A, Belle K, Ghiam BK, et al · · 2021 · cited 12× · PMID 34232272 · DOI 10.1167/tvst.10.8.4 -
Multi-Wavelength Photobiomodulation Ameliorates Sodium Iodate-Induced Age-Related Macular Degeneration in Rats.
Goo H, Lee MY, Lee YJ, Lee S, et al · · 2023 · cited 9× · PMID 38139223 · DOI 10.3390/ijms242417394 -
Photobiomodulation for non-exudative age-related macular degeneration.
Henein C, Steel DH. · · 2021 · cited 9× · PMID 34097768 · DOI 10.1002/14651858.cd013029.pub2 -
Red Light Irradiation In Vivo Upregulates DJ-1 in the Retinal Ganglion Cell Layer and Protects against Axotomy-Related Dendritic Pruning.
Beirne K, Freeman TJ, Rozanowska M, Votruba M. · · 2021 · cited 7× · PMID 34445085 · DOI 10.3390/ijms22168380
Verify or expand the search:
- PubMed search for NCT03878420
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Valeda PBM treatment
Trials testing the same drug.
- NCT04065490 — Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE III) · NA · active not recruiting
Other recruiting trials for Dry Age-related Macular Degeneration
Currently open trials in the same condition.
- NCT06536062 — Age-related Macular Degeneration of Atrophic Type Treated With Umbilical Cord Blood Enriched With Platelet Plasma. · NA · recruiting
- NCT06229665 — Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITEIIIB) · Phase 2, PHASE3 · active not recruiting
- NCT05797896 — Investigating Geographic Atrophy Insights (i-GAIN) Natural History Study · active not recruiting
- NCT05706896 — Atrophic Age-related Macular Degeneration Treated With Intravitreal Injections of Umbilical Cord Blood Platelet-rich Pla · NA · recruiting
- NCT04627428 — Safety and Tolerability of RPE Stem Cell-derived RPE(RPESC-RPE) Transplantation in Patients With Dry Age-related Macular · Phase 1, PHASE2 · recruiting
Other LumiThera, Inc. trials
Trials by the same sponsor.
- NCT06229665 — Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITEIIIB) · Phase 2, PHASE3 · active not recruiting
- NCT04522999 — Study of Photobiomodulation Effect on Electroretinogram Outcomes in Dry Age-Related Macular Degeneration · NA · completed
- NCT04065490 — Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE III) · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03878420 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by LumiThera, Inc.
- Last refreshed: 2 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03878420.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing