None listed
Conditions
Brief summary
This is an open label study of patients with macular oedema, secondary to diabetic retinopathy who are naïve or have minimal exposure to intravitreal anti- vascular endothelial growth factor (VEGF) therapy. The study will assess the effectiveness of a treat and extend regimen of intravitreal Aflibercept (Eylea) in a clinical setting,
Interventions
Only one eye will be selected as the treatment eye. If the patient has two eyes with macular oedema the most recently diagnosed eye will be selected as the study eye.
All subjects will receive 5 doses of 2.0mg intravitreal aflibercept one month (4 weeks) apart.
The injections will be administered by the patient's treating ophthalmologist.
Thereafter study visits and treatment will be determined by disease activity and the treating ophthalmologist. If no disease activity is present the interva
Only one eye will be selected as the treatment eye. If the patient has two eyes with macular oedema the most recently diagnosed eye will be selected as the study eye. All subjects will receive 5 doses of 2.0mg intravitreal aflibercept one month (4 weeks) apart. The injections will be administered by the patient's treating ophthalmologist. Thereafter study visits and treatment will be determined by disease activity and the treating ophthalmologist. If no disease activity is present the intervals between treatments will increase by two weeks to a maximum of 12 weeks. If disease activity is present the treatment interval will decrease by 2 weeks (if >4 weeks) or be rescheduled to 4 weekly until disease activity is minimised. The study, and this treatment regimen, will continue for two years from the date of enrolment with a maximum of 26 injections over the course of the study.
Sponsors
Nitin Verma
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Written informed consent must be obtained prior to any study measures being performed • Male or female participants aged 18 years and over, with type 1 or type 2 diabetes mellitus • Female patients of childbearing potential should be counselled on potential risks and should use effective contraceptive measures during treatment and for up to three months after treatment ceases. • Diagnosis of diabetic macular oedema (DME) with central macular involvement in study eye diagnosed by fluorescein angiography. • Decrease in vision in the study eye as a consequence of DME • Best corrected baseline visual acuity (BCVA) between 24 and 78 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 3 meters. • Study eye Central retinal thickness (CRT) at least 300µm on OCT ( Heidelberg Spectralis OCT)
Exclusion criteria
• Pregnant or lactating women and women of reproductive age not using effective contraception. • Systemic disease or a condition (controlled or uncontrolled) that, in the opinion of the investigator, might regress, recur or change and consequently have a potential impact (bias) on the assessment of study outcomes. • Stroke or myocardial infarction less than 3 months prior to screening for eligibility. • Uncontrolled blood pressure (defined as a systolic of >160mmHg or diastolic >100mmHg) at screening • Uncontrolled diabetes, defined by HBA1c>12% • Patients with known sensitivity to Aflibercept preparations • Patients taking or planning to take any systemic medications known to be toxic to the lens or retina or optic nerve. • Any active ocular or peri-ocular infection or inflammation • Active proliferative diabetic retinopathy in study eye. • Visually significant cataract • Any other macular pathology in the study eye that may influence the outcomes of the study (e.g. laser burns or scars, wet Age-related macular degeneration, macular holes.) • Uncontrolled glaucoma • Any previous treatment with anti-angiogenic drugs in the study eye within 120 days of commencing the study. • Any previous treatment with anti-angiogenic drugs in the fellow eye within 90 days of commencing the study. • More than two previous macular laser photocoagulation treatments in the study eye in the past 6 months. • Pan-retinal or macular laser photocoagulation in study eye within the 90 days of commencing the study. • Treatment of study eye with intraocular /peri ocular corticosteroids within 120 days of commencing the study.
Outcome results
None listed