Neovascular (wet) age-related macular degeneration (nAMD) Eye Diseases Other retinal disorders
Conditions
Interventions
All patients will receive intraocular injections of Avastin® to treat nAMD. Patients will receive either a conventional dose (1.250 mg) or a low dose (0.625 mg) each month for three consecutive months
Sponsors
Nottingham University Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to an event, i.e. vision deterioration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Frequencies of adverse effects of treatment 2. Corrected distance visual acuity (VAlogMAR), measured as the number of letters read on a standard ETDRS chart at 1 metre Measured 18 and 30 months after the start of recruitment and then annually | — |
Countries
United Kingdom
Outcome results
None listed