Choroidal neovascularisation in age related macular degeneration MedDRA version: 14.0 Level: LLT Classification code 10015902 Term: Exudative senile macular degeneration of retina System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Trade Name: avastin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: bevacizumab
Other descriptive name: BEVACIZUMABUM
C
Sponsors
Belfast Health and Social Care Trust
Queen's University Belfast, Research and Regional Services
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Adults of either sex aged 50 years and older; •Newly referred for the treatment of nAMD in the first or second eye; •Corrected distance logMAR visual acuity (VAlogMAR) =25 letters read on a standard ETDRS chart at 1 metre; •Any component of the neovascular lesion (CNV, blood, serous pigment epithelial detachment, elevated blocked flourescence) involving the centre of the fovea. If a fellow eye develops CNV from AMD, it will be treated with the optimum locally available treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Age less than 50 years •Corrected VAlogMAR 6000µm (equivalent to about 12 disc diameters) •Argon laser treatment to the proposed study eye within the last 6 months •Presence of thick blood involving the centre of the fovea •Presence of other active ocular disease causing concurrent vision loss, e.g. diabetic retinopathy. •Patients with 8 or more dioptres of myopia. •Previous treatment with PDT or a VEGF inhibitor in the eye being considered for inclusion. •Pregnant and or lactating women •Women with child bearing potential (i.e. not sterilised or not post menopausal) who are unwilling to use contraception •Men with a spouse or partner with child bearing potential unless the participant has agreed to use condoms A past medical history of cardiovascular disease or cardiovascular comorbidity, e.g. previous myocardial infarction or stroke, current angina, will not be an exclusion criterion. However, such factors will be documented carefully at the time of recruitment, and the potential benefits and harms of treatment discussed carefully with potential participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the relative effectiveness of two vascular endothelial growth factor (VEGF) inhibitors, i.e. Lucentis(Ranibizumab) and Avastin(Bevacizumab), on visual outcome in patients with choroidal neovascularisation form age related macular degeneration(AMD).; Secondary Objective: 1. To estimate the effectiveness of more frequent vs. less frequent VEGF inhibition in improving or mainataining visual function, with stringent criteria for restarting treatment to prevent visual acuity loss in patients receiving less frequent treatment. 2. To estimate the cost-effectiveness of the alternate treatment strategies outlined above. ;Primary end point(s): 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. | — |
Countries
United Kingdom
Outcome results
None listed