A randomised controlled trial of alternative treatments to inhibit VEGF in age-related choroidal neovascularisatio

Not Applicable

Completed

• Conditions: Age-related macular degeneration (AMD); Eye Diseases

• Registration Number: ISRCTN92166560
• Lead Sponsor: Royal Group of Hospitals Trust (UK)

Brief Summary

2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22578446 results 2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22555112 results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23870813 results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24070809 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25079928 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/26445075 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27073205 results 2018 Results article in http://www.ncbi.nlm.nih.gov/pubmed/30555977 results 2019 Results article in http://www.ncbi.nlm.nih.gov/pubmed/30301555 results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35314388/ 7-year follow-up (added 24/10/2022) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32359843/ Long-term visual outcomes (added 24/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-04-19
• Study Completion: 2012-11-30
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 610

Inclusion Criteria

1. Adults age =50 of either sex
2. Newly referred for the treatment of CNV caused by Age-related Macular Degeneration (AMD) in the first or second eye
3. Corrected 1 metre logarithmic minimal angle resolution visual acuity (VAlogMAR) =25 letters read on a standard Early Treatment Diabetic Retinopathy Study (ETDRS) chart
4. CNV involving the centre of the fovea

If a fellow eye develops CNV from AMD, it will be treated with the optimal locally available treatment.

Exclusion Criteria

1. Corrected 1 metre VAlogMAR <25 letters
2. Long standing CNV evidenced by the presence of fibrosis in excess of 50% of the total lesion
3. Presence of other active ocular disease causing concurrent vision loss, e.g. diabetic retinopathy
4. Previous treatment with PhotoDynamic Therapy (PDT) or a VEGF inhibitor in the eye being considered for inclusion

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is corrected 1 metre VAlogMAR, measured as the number of letters read on a standard ETDRS chart. The primary end point will be VAlogMAR after two years of follow-up.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary outcomes will be analysed after one and two years of follow-up, unless otherwise stated.<br> 1. Frequencies of adverse effects of treatment<br> 2. Generic and vision-specific health-related quality of life (HRQoL)<br> 3. Treatment satisfaction<br> 4. Cumulative resource use/cost, and cost-effectiveness<br> 5. Clinical measures of vision<br> 6. CNV morphology (from masked grading of fundus fluorescein angiograms [FFA] and optical coherence tomography scans [OCTs]).<br> 7. Distance VAlogMAR after all patients have been followed for 1 year after starting treatment.<br> 8. Survival free from treatment failure (i.e. satisfying one or more of the criteria for re-treatment).<br>