Intravitreal Aflibercept for the Treatment of Treatment Resistant Diabetic Macular Oedema
A prospective, open-label clinical trial, to evaluate the efficacy of intravitreal Aflibercept for the treatment of treatment resistant diabetic macular oedema
Andrew Chang
50 participants
Jul 6, 2014
Interventional
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria19
- 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)
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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.
Locations(1)
View Full Details on ANZCTR
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ACTRN12614001307695