Efficacy and safety of retinal rejuvenation using Ellex 2RT laser in age-related maculopathy

Completed

• Conditions: Topic: Eye; Subtopic: Eye (all Subtopics); Disease: Ophthalmology; Eye Diseases

• Registration Number: ISRCTN87850962
• Lead Sponsor: King's College Hospital NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-20
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

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

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 Pregnancy at baseline and the patient will be withdrawn from the study if she becomes pregnant during the course of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual acuity; Timepoint(s): 1 year

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration