None listed
Conditions
Brief summary
This study is designed to specifically target on patients with diabetic macular oedema who are poorly responsive to current anti-VEGF therapy (bevacizumab or ranibiznumab), and evaluate whether changing the therapeutic agent to intravitreal ziv aflibercept injection would lead to improved functional and anatomical outcomes. The 48 week treatment duration is appropriate for a pilot study. The hypothesis of this study is that compounded intravitreal ziv Aflibercept injection may be effective in causing resolution of persistent sub or intraretinal fluid despite previous treatment with bevacizumab or ranibizumab by counteracting the effect of both VEGF-A and placental growth factor, with increased binding affinity. At the very least, being as effective as previous treatment but with fewer treatments.
Interventions
Intravitreal injection of ziv Aflibercept 2mg monthly
For three months then as required monthly depending on clinical indications of retinal fluid at the clinical discretion of ophthalmologist
Sponsors
Dr Andrew Riley
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: Ability to provide informed consent and complete study assessments Age 18 years or older Diabetic macular oedema not responding to compounded Avastin (Bevacizumab or ranibizumab) Best corrected baseline visual acuity between 6/6 to 6/60 on ETDRS chart Presence of sub retinal fluid or cystic intraretinal oedema on spectral domain OCT (SD-OCT) [Spectralis] Documentation of the presence of sub retinal fluid or cystoid oedema less than 42 days since last treatment with an antiVegf agent.
Exclusion criteria
Pregnancy Recent CVA or MI
Outcome results
None listed