Physician Portal

Ellex 2RT® Research

2RT® Retinal Rejuvenation
― Clinically proven to be safe and effective

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.

2RT® for Early AMD


Laser Intervention in Early AMD (Lead) Multi-center Trial

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). 

 

24-month Pilot Study Results: 2RT® for Early AMD

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.

Key Findings:

  • Drusen reduction was maintained out to the second year, with fundus autofluorescence exhibiting a stabilized RPE monolayer in the area of 2RT®-induced drusen regression in 75% of patients.
  • At 12 months and 24 months drusen reduction was 40% and 35% respectively, compared to 11% in the natural history cohort.
  • There was no sign of potential to progression to atrophy (as characterized by increase in fundus auotfluorescence)
  • No patient was observed to progress to advanced ‘wet’ form of AMD: At 24 months post-treatment no patients had developed CNV.

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).

 

12-month Pilot Study Results: 2RT® for Early AMD

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 2RT® to assess the ability of 2RT® to delay the progression of early AMD.

Key Findings:

  • A single application of the 2RT® laser produced bilateral improvements in macular function and appearance.
  • Drusen area was reduced in 44% of treated eyes and 22% in fellow eyes.
  • 2RT® produced benefits in visual function as measured by flicker perimetry sensitivity. The biggest changes occurred in the central one degree of the treated eye, where greatest pre-treatment dysfunction existed.

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

2RT® for CSME


Pilot Study – St. Thomas Hospital, UK

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.

Key Findings:

  • Mean change in LogMAR visual acuity between baseline and 6 months:

    11% patients improved ≥ 3 lines
    32% patients improved ≥ 2 lines
    43% patients stable (within ± 1 line)
  • Central macular thickness decreased >5% in 46% of treated eyes and stabilized (within ±5% change from baseline) in 39% treated eyes.
  • Microperimetry examination confirmed preserved integrity of photoreceptors and improvement, correlated by decreased macular thickness.
  • Therapeutic benefits were achieved without associated side effects of conventional (thermal) retinal photocoagulation.

 

Pilot Study – Royal Adelaide Hospital, Australia

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®.

Key Findings:

  • In the short-term, 2RT® approximates the clinical efficacy of retinal photocoagulation.
  • The difference in retinal thickness between the two groups was 5.6mm in favor of 2RT®, secondary outcome of change in VA of 0.02 in favor of 2RT®.
  • No observable adverse events reported.
  • 2RT® used approximately 500 times less laser energy than retinal photocoagulation and induced no collateral damage.

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

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