None listed
Conditions
Brief summary
The aim of the study is to evaluate the effectiveness of intravitreal Aflibercept in the treatment of previously treated choroidal neovascularisation (CNV) secondary to age-related macular degeneration MD). This is an open label study in patients who have been previously treated with intravitreal anti-VEGF drug (ranibizumab or bevacizumab) for AMD and have persisting disease activity despite previous monthly intravitreal injections. All subjects will initially receive 3 monthly doses of 2.0mg of intravitreal Aflibercept injection and then have 2.0mg of intravitreal Aflibercept at two monthly intervals for the next 9 months. At the close of the trial the effectiveness of Aflibercept in the mangement of wet age related macular degeneration that has not responded to our existing therapies will be assessed.
Interventions
The trial will study the effectiveness of intravireal AFLIBERCEPT in the treatment of exudative wet Macular degeneration which thus far has not responded to other anti VEGF agents (Bevacizumab and Ranibizumab).
The dose of aflibercept administered is 2 mg. The drug will delivered by intravitreal injection every 4 weeks for the first 12 weeks of the study. Thereafter the drug will be administered by intravitreal injection every 8 weeks until the close of the trial at week 52. The duration of th
The trial will study the effectiveness of intravireal AFLIBERCEPT in the treatment of exudative wet Macular degeneration which thus far has not responded to other anti VEGF agents (Bevacizumab and Ranibizumab). The dose of aflibercept administered is 2 mg. The drug will delivered by intravitreal injection every 4 weeks for the first 12 weeks of the study. Thereafter the drug will be administered by intravitreal injection every 8 weeks until the close of the trial at week 52. The duration of the study is 12 months. For the dutration of the study, participants will attend for review every 4 weeks but they will only require treatment every second visit. During each visit the patients response to treatment will be assessed with OCT (to measure the macula thickness) and their visual acuity will be assessed.
Sponsors
Greenlane Clinical Centre Auckland District Health Board
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ability to provide informed consent and complete study assessments 2. Age 50 years or older 3. CNV secondary to AMD 4. Best corrected baseline visual acuity between 6/6 to 6/60 on ETDRS chart 5. Presence of subretinal fluid or cystic intraretinal oedema on spectral domain OCT (SD-OCT) [Spectralis] after at least four anti-VEGF treatments within minimum of 6 months and maximum of 5 years before enrollment of the study. 6. Documentation of the presence of subretinal fluid or cystoid oedema less than 42 days since last treatment with an antiVegf agent.
Exclusion criteria
1. Pregnancy or lactation 2. Premenopausal women not using contraception 3. Prior anti-VEGF injection in the study eye within 30 days of baseline 4. Prior treatment with photo dynamic therapy (PDT) within 90 days of baseline and more than 6 prior PDT treatments 5. Significant subretinal fibrosis or atrophy 6. Prior treatment with triamcinolone in the study eye within six months of baseline 7. Intraocular surgery in the study eye within 2 months of baseline 8. Prior vitrectomy or other surgical intervention for AMD in the study eye
Outcome results
None listed