None listed
Conditions
Brief summary
This is an open label study in patients who have been previously treated with intravitreal anti-VEGF drug for DMO and have persisting DMO despite regular injections. The study will describe the effectiveness, safety of intravitreal aflibercept and changes in health-related quality of life (HRQoL) among these patients.
Interventions
All subjects will initially receive 5 monthly doses of 2.0mg of intravitreal aflibercept injections and then have 2.0mg of intravitreal aflibercept at two monthly intervals for the subsequent 7 months.
Sponsors
Andrew Chang
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
*Ability to provide informed consent and complete study assessments *Age 18 years or older *Macular oedema involving in central macula secondary to type 1 or type 2 diabetic mellitus in study eye. *Best corrected baseline visual acuity between 85-34 letters on early treatment in diabetic retinopathy study (ETDRS) chart (Snellen equivalent 6/6 to 6/60) on study eye *Presence of central diabetic macular odema (DMO) >300 microns on spectral domain optical coherence tomography (SD-OCT) after at least 4 anti-VEGF (vascular endothelial growth factor) treatments within minimum of 6 months *Documentation of the presence of macular oedema at least 30 days since last treatment.
Exclusion criteria
*Pregnancy or lactation *Premenopausal women not using contraception *Prior anti-VEGF injection in the study eye within 30 days of baseline *Prior treatment with triamcinolone in the study eye within 3 months of baseline *Intraocular surgery in the study eye within 2 months of baseline *Macular laser within 2 months or previous laser scar would prevent the improvement of macular function *Prior vitrectomy in the study eye within 3 months of baseline *Current vitreous haemorrhage or inflammation in the study eye *Uncontrolled glaucoma in the study eye. Intraocular pressure (IOP) greater than 30mmHg on maximal medical therapy. *Active proliferative diabetic retinopathy (PDR) in the study eye. *Ischemic maculopathy on fluorescein angiography defined as a total area of capillary loss greater than 2 disc areas (> 5mm2) within the ETDRS macular grid or a foveal avascular zone greatest linear diameter of > 1000 microns *Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration, retinal vein occlusion) *Macular oedema due to other causes including vitreous traction *An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy) *Uncontrolled diabetes mellitus, as defined by HbA1c > 12% *Severe media opacity *History of stroke, acute myocardial infarction and transient ischemic attack within 3 months of study enrollment *Allergy to fluorescein dye. *Uncontrolled high blood pressure (blood pressure > 180/110 mmHg)
Outcome results
None listed