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

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

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of laser treatment to see if it can slow down or partly reverse early age-related macular degeneration (AMD). AMD is a disease that damages the light-sensitive layer at the back of the eye and can eventually lead to loss of central vision. There is currently no approved treatment for early AMD, and this study is investigating a specially designed laser that targets the cells involved in the disease. You may be eligible if: - You are between 45 and 100 years old - You have early AMD with large deposits (drusen) and pigment changes in both eyes - You have impaired dark adaptation in both eyes - Your vision is equal to or better than 6/19 You may NOT be eligible if: - You have advanced AMD - You have diabetic retinopathy or glaucoma - You have had previous retinal surgery or laser treatment - You have other significant retinal or eye conditions - You have active cancer or other serious systemic illness - You are allergic to fluorescein dye Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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