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RecruitingACTRN12609001056280

Retinal regeneration Laser Treatment in Early Age-related Maculopathy

Evaluation of the effect of retinal regeneration laser therapy on visual function and clinical fundus status in Early Age-related Maculopathy(AMD)

Sponsor

Ellex

Enrollment

50 participants

Start Date

Aug 25, 2009

Study Type

Interventional

Conditions

Early Age related Maculopathy

Summary

This is a clinical research study to trial a new laser treatment with the aim of slowing or partially reversing the progression Age Related Macular Degeneration (AMD), a disease which affects the retina and can ultimately lead to central vision blindness. Curently there is no treatment available for Early AMD. The study device is a laser which has been specially developed to treat retinal diseases and in this setting it is hoped it will target cells involved in the disease process and exhibit a wound healing effect which may lead to a delay or halt in the progression of AMD. The results of the laser will be monitored by asessing clinical markers and measuring visual functions.

Eligibility

Sex: Both males and femalesMin Age: 45 YearssMax Age: 100 Yearss

Inclusion Criteria3

  • Bliateral multiple large drusen( >125 micron) and pigment changes.
  • Impaired dark adaptation in both eyes.
  • Vison equal to or better than 6/19.

Exclusion Criteria9

  • Advanced AMD.
  • Diabetic retinopathy.
  • Glaucomous changes.
  • Pathology which significantly compromises therapeutic or investigative access to the fundus fo the eye.
  • Intraocular surgery other than uncomplicated cataract surgery > 6 months.
  • History or evidence of previous retinal disorder or retinal laser treatment or intra-ocular inflammotory disease.
  • Other retianl or ocular disease or recent symptoms of wet AMD.
  • Known allergic hypersensitivity to fluorescein.
  • Active malignant diseases or other serious systemic diseases.

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Interventions

The intervention involves the use of a new laser called the 2RT retinal Regeneration Therapy laser. The laser will be applied once only to one eye. It will be fired approximately 12 times near the arc

The intervention involves the use of a new laser called the 2RT retinal Regeneration Therapy laser. The laser will be applied once only to one eye. It will be fired approximately 12 times near the arcades of the retina. It utilises low energy and extremely short nanosecond duration laser to produce very limited effects.

Locations(1)

Australia

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ACTRN12609001056280