Ellex Medical Lasers Limited, a global leader in the design and manufacture of ophthalmic laser and ultrasound systems, announced today initial clinical results of an ongoing study for non-thermal Retina Regeneration Therapy (Ellex 2RT(TM)). Results demonstrate the therapy's potential to improve and stabilize visual acuity and to reduce retinal edema in patients with diabetic maculopathy and macular edema without causing any damage to the photoreceptors.
Peter Hamilton, MD, FRCOph, the principal clinical investigator in the Ellex 2RT research program at St. Thomas Hospital, London, presented the initial clinical trial results today at the Retina Subspecialty Day of the annual meeting of the American Academy of Ophthalmology (AAO).
"The first phase clinical outcomes have confirmed Ellex 2RT's ability to treat diabetic maculopathy without damaging the neuro-retina," commented Professor John Marshall, principal investigator of the Ellex 2RT research program. "This means that Ellex 2RT may change the way diabetic maculopathy patients are treated and it shows potential for intervention in early stage Age-Related Macular Degeneration (AMD) before significant loss of vision has occurred."
"We are encouraged by the first patient data presented today as it provides the assurance we were looking for to expand Ellex 2RT research," commented Peter Falzon, Ellex CEO. "The next phase clinical trials will be essential in establishing Ellex 2RT's potential as an early stage therapy for retinal diseases."
The clinical trials are conducted under the direction of Professor John Marshall, Ph.D., FRCPath, who is Frost Professor of Ophthalmology at the Rayne Institute and Head of the Academic Department of Ophthalmology at King's College, University of London.
The prospective study, which includes 18 patients (29 eyes) was designed to evaluate the effectiveness of selective RPE treatment in diabetic maculopathy and macular edema. The duration of the study is 12 months with patient follow up at three, six and twelve months post-op. All patients received treatments with Ellex 2RT prototype lasers that were developed specifically for the Ellex 2RT research program by Ellex's advanced research team in Adelaide, Australia. Ellex has international patents pending for the technology and the method.
At three months the majority of patients experienced improvement in visual acuity and central macular thickness (CMT) as measured by optical coherence tomography. Central macular thickness decreased in 55% of eyes and remained stable in 24%. An increase in central macular thickness was observed in only 20% of eyes. In addition, micro-perimetry confirmed that there was no evidence of laser damage to the photoreceptor cells.