Efficacy and safety of retinal rejuvenation using Ellex 2RT laser in age-related maculopathy (RETILASE trial) | Not Recruiting
Efficacy and safety of retinal rejuvenation using Ellex 2RT laser in age-related maculopathy (RETILASE trial)
RETILASE
Trial Source

Health Conditions
  • Topic: Eye
  • Subtopic: Eye (all Subtopics)
  • Disease: Ophthalmology
Not Recruiting
Recruitment Status
ISRCTN87850962
Primary Trial ID Number
Summary
Age Related Macular Degeneration (AMD) is the leading cause of visual impairment amongst the elderly. In the United Kingdom, there is an estimated 608,213 patients diagnosed with AMD. This will increase to 755,867 by the end of the next decade, accounting for 22.5% of the ageing population. [1] The clinical hallmark of AMD is the appearance of drusen which are localized deposits or debris lying between the basement membrane of the retinal pigment epithelium (RPE) and the Bruch's membrane. They are visible ophthalmoscopically as yellow-white deposits clustered mainly in the central macula. Although drusen alone do not account for significant loss of visual acuity in AMD, they can lead to deficits in macular function such as color contrast sensitivity and macular sensitivity. Approximately 10% of the eyes with drusen progress to the advanced forms of AMD every year. There are two main forms of advanced AMD: the geographic atrophy for which there are no treatment options and the neovascular subtype characterized by the development of choroidal neovascularization (CNV) that results in profound and rapid deterioration of vision and accounts for 80% of the blindness due to this condition. Given that AMD is the leading cause of blindness in the elderly despite the availability of costly drugs that are used to treat the advanced form (neovascular AMD), it is essential that preventive measures are available to delay progression of the disease to these advanced forms. The disease has to be curtailed at the early stages of the disease to prevent or reduce the impact on visual function. This project aims to use a minimally invasive laser technology to clear the aging retina off debris (drusen) so that the retina is rejuvenated making it less prone to the effects of multiple stressors that stimulate the progression to advanced AMD. More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=10926
Primary Outcome Measures
  • Visual acuity; Timepoint(s): 1 year
Secondary Outcome Measures
  • Not provided at time of registration
Research Question
  • Age Related Macular Degeneration (AMD) is the leading cause of visual impairment amongst the elderly. In the United Kingdom, there is an estimated 608,213 patients diagnosed with AMD. This will increase to 755,867 by the end of the next decade, accounting for 22.5% of the ageing population. [1] The clinical hallmark of AMD is the appearance of drusen which are localized deposits or debris lying between the basement membrane of the retinal pigment epithelium (RPE) and the Bruch's membrane. They are visible ophthalmoscopically as yellow-white deposits clustered mainly in the central macula. Although drusen alone do not account for significant loss of visual acuity in AMD, they can lead to deficits in macular function such as color contrast sensitivity and macular sensitivity. Approximately 10% of the eyes with drusen progress to the advanced forms of AMD every year. There are two main forms of advanced AMD: the geographic atrophy for which there are no treatment options and the neovascular subtype characterized by the development of choroidal neovascularization (CNV) that results in profound and rapid deterioration of vision and accounts for 80% of the blindness due to this condition. Given that AMD is the leading cause of blindness in the elderly despite the availability of costly drugs that are used to treat the advanced form (neovascular AMD), it is essential that preventive measures are available to delay progression of the disease to these advanced forms. The disease has to be curtailed at the early stages of the disease to prevent or reduce the impact on visual function. This project aims to use a minimally invasive laser technology to clear the aging retina off debris (drusen) so that the retina is rejuvenated making it less prone to the effects of multiple stressors that stimulate the progression to advanced AMD. More details can be found at http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=10926
Design Type
Sorry, this information is not available
Ethics Approval
11/LO/1043
Publications
Sorry, this information is not available
Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Adult
Participant Type
Patient
Trial Sample Size
80
Participant Inclusion Criteria
  • 1. Patients of either sex aged 55 years or over
  • 2. Diagnosis of age related maculopathy that meet the criteria of large drusen (=125 µ) in at least 1 eye
  • 3. Best corrected visual acuity in the study eye between 50 to 90 ETDRS letters at baseline visit
  • 4. Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
  • 5. No previous macular laser therapy to study eye
  • 6. Written informed consent and willingness and ability to be followed up for 24 months.; Target Gender: Male & Female; Upper Age Limit 90 years ; Lower Age Limit 55 years
Participant Exclusion Criteria
  • 1. Drusenoid PED, Choroidal neovascularisation and geographic atrophy in the study eye
  • 2. Macular ischaemia (FAZ > 1000µm in diameter or moderate perifoveal capillary loss in fluorescein angiogram) or diabetic retinopathy
  • 3. Macular oedema of any cause such as wet AMD, diabetic macular oedema, pseudophakic macular oedema or taut posterior hyaloid
  • 4. Co-existent ocular disease that in the investigator’s discretion would lead to decrease visual acuity by 3 lines or more by end of 12 months
  • 5. History of thermal lasers or treatment with intravitreal antiVEGF agents or steroids for any retinal conditions
  • 6. Participation in an investigational trial within 30 days of randomisation that involved treatment with any drug including those that has not received regulatory approval at the time of study entry
  • 7. Anticipated major ocular surgery (including cataract extraction) for the period of the trial
  • 8. Amblyopia in study eye
  • 9. Known allergy to fluorescein dye or to any component of the study drug
  • 10. Pregnancy at baseline and the patient will be withdrawn from the study if she becomes pregnant during the course of the study
Interventions
2RT, nano second laser technology 400um spot size at least 25 spots
Design Details
Sorry, this information is not available
Study Design
Randomised; Interventional; Design type: Not specified
Results Reporting
Sorry, this information is not available
Acronym
RETILASE
Scientific Title
Sorry, this information is not available
Secondary Trial Identifying Number
10926
Website
Sorry, this information is not available
Study Funded By
J P Moulton Charitable Foundation (UK)
Funder Type
Sorry, this information is not available
Study Sponsored By
King's College Hospital NHS Foundation Trust (UK)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

01 Dec 2011

Recruitment End Date

01 Jun 2013

Trial End Date

01 Jun 2013

Date added to Registry

20 Feb 2012

Last Updated

20 Feb 2012