Ellex 2RT™ Retinal Rejuvenation has been validated as a safe and effective treatment option for early AMD and CSME through a series of randomized control studies.
Multi-center, randomized trial investigating the safety and efficacy of (2RT™) nanosecond laser intervention in early age-related macular degeneration.
Launched in 2012, 296 patients with bilateral high-risk early AMD (AREDS simplified severity score of 2-3) were recruited and randomly assigned for treatment with 2RT™ or a sham laser procedure. Patients either received the 2RT™ procedure, or sham laser procedure in one eye, with treatment to be repeated at six-monthly intervals, as per the protocol design.
The primary endpoint was progression to advanced AMD in the treated eye, as assessed by ocular examination, color fundus photography, Ocular Coherence Tomography (OCT) and fluorescein angiography at 36 months post initial intervention. The secondary endpoint was progression to advanced AMD in the non-treated eye.
The complete trial protocol for the LEAD trial is available at the Clinical Trials Registry (ClinicalTrials. gov Identifier: NCT01790802).
Nanosecond laser therapy reverses pathological and molecular changes in age related macular degeneration without retinal damage
24-month clinical data, which is a follow-up to the 12-month pilot study “2RT™ for Early AMD” (ACTRN 1260900E1056280), conducted at the Centre for Eye Research Australia (CERA) by Professor Robyn Guymer AM, MBBS PhD, FRANZCO. Fifty (50) AMD patients were treated with a single application of 2RT™ with subsequent changes in drusen area compared against a natural history cohort at 12 months and 24 months post-treatment.
Fletcher EL, et al. Nanosecond laser therapy reverses pathological and molecular changes in age related macular degeneration without retinal damage. Federation of American Societies of Experimental Biology. November 2014; 28 (11).
Nanosecond laser application in intermediate AMD – 12-month results of fundus appearance and macular function
12-month prospective non-randomized, pilot intervention study, “2RT for Early AMD” (ACTRN 1260900E1056280) conducted at the Centre for Eye Research Australia (CERA) by Professor Robyn Guymer, MB, BS PhD, FRANZCO. Fifty (50) patients with bilateral intermediate AMD (drusen > 125µm) were treated with a single application of 2RT2RT to assess the ability of 2RT® to delay the progression of early AMD.
Guymer RH, et al. Nanosecond-laser application in intermediate
AMD – 12-month results of fundus appearance and macular function. Clin Experiment Ophthalmol. 2013 Oct 3. doi: 10.1111/ceo.12247
Retinal Rejuvenation Therapy for Diabetic Macular Edema
Prospective, open-labelled, pilot study conducted in 2012 to investigate the safety and efficacy of 2RT™ in the treatment of CSME. Patients with newly diagnosed DME underwent 2RT™ with pulsed energy 78 µJ-131 µJ, with the number of shots dependant upon patient extent of edema and leakage on FFA.
Randomized Clinical Trial of a New Nanopulse Retinal Laser versus Conventional Photocoagulation for the Treatment of Diabetic Macular Edema
Pilot, prospective, randomized non-inferiority trial conducted at the Royal Adelaide Hospital over a 6-month followup period. Patients with diabetic macular edema (250-550µm), BCVA (ETDRS) ≥19 letters (≥20/400) and retinal thickness (OCT) ≥250µm in the central subfield or ≥300µm in ≥1 of the inner subfields, underwent approximately 20-120 applications of 2RT™.
Casson RJ. et al., Pilot randomized trial of a nanopulse retinal laser versus conventional photocoagulation for the treatment of diabetic macular oedema. Clin Experiment Ophthalmol. 2012 Aug;40(6):604-10