Comparing different dosing regimens of Avastin® in the treatment of wet age-related macular degeneratio

Phase 4

Completed

• Conditions: eovascular (wet) age-related macular degeneration (nAMD); Eye Diseases; Other retinal disorders

• Registration Number: ISRCTN95654194
• Lead Sponsor: ottingham University Hospitals NHS Trust (UK)

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25873213

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-22
• Study Completion: 2017-03-31
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 812

Inclusion Criteria

1. Adults of either sex aged 50 years and older
2. Newly referred for the treatment of nAMD
3. Corrected distance logarithm of the minimum angle of resolution visual acuity (VAlogMAR) greater than or equal to 20 letters and less than 70 letters read on a standard ETDRS chart at 1 metre
4. Any component of the neovascular lesion (choroidal neovascularisation [CNV], blood, serous pigment epithelial detachment, elevated blocked fluorescence) involving the centre of the fovea

Exclusion Criteria

1. Aged less than 50 years
2. Corrected VAlogMAR less than 20 letters at 1 metre
3. Long standing CNV evidenced by the presence of fibrosis in excess of 50% of the total lesion
4. Greatest linear diameter greater than 6000 µm (equivalent to about 12 disc diameters)
5. Argon laser treatment to the proposed study eye within the last 6 months
6. Presence of thick blood involving the centre of the fovea
7. Presence of other active ocular disease causing concurrent vision loss, e.g. diabetic retinopathy
8. Previous treatment with photodynamic therapy (PDT) or a vascular endothelial growth factor (VEGF) inhibitor in either eye
9. Patients with 8 or more diopters of myopia
10. Pregnant and or lactating women
11. Women with child bearing potential (i.e. not sterilised or not post-menopausal) who are unwilling to use contraception
12. Men with a spouse or partner with child bearing potential unless the participant has agreed to use condoms
13. Patients with known hypersensitivity to recombinant human or humanised antibodies

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to an event, i.e. vision deterioration

Secondary Outcome Measures

Name	Time	Method
<br> 1. Frequencies of adverse effects of treatment<br> 2. Corrected distance visual acuity (VAlogMAR), measured as the number of letters read on a standard ETDRS chart at 1 metre<br><br> Measured 18 and 30 months after the start of recruitment and then annually<br>