None listed
Conditions
Brief summary
This proposal aims to answer a critical question in the Diabetic Macular Oedema management, and by testing regularly with conventional and novel ophthalmic imaging to predict early response to anti-vascular endothelial growth factor (VEGF) therapy. This anti-vascular endothelial growth factor (VEGF) therapy, is standard of care approved by the Therapeutic Goods Administration for Diabetic Macular Oedema treatment. Diabetes is a common condition that can result in severe vision loss. The structure of the eye can be considered very similar to a camera and diabetes causes damage to the retina which is analogous to the film in the camera. More specifically, diabetes causes injury to blood vessels in the retina causing them to bleed and leak fluid. A spectrum of these retinal changes can occur in diabetes and is referred to as diabetic retinopathy. Currently, fluorescein angiography (FA) is considered the gold-standard technique for visualising the blood vessels in the retina. It is a more precise technique for detecting retinal vascular changes than clinical examination. FA is a technique that was described over 50 years ago and is still widely used. FA is an invasive technique that involves the injection of fluorescein dye into the human vein with images captured by a camera as the dye circulates through the retina. FA is associated with adverse effects including nausea, dizziness and rarely, death due to anaphylaxis. FA is also an expensive procedure and cannot be repeated frequently. Over the past 3 years, a new technique known as optical coherence tomography angiography (OCTA), has come into widespread use for the clinical management of diabetic retinopathy. OCTA is a non-invasive technique that allows rapid image acquisition (3-5 seconds) of the retinal circulation. It is a commercial technique that is widely used by ophthalmologists today. Most importantly, our own research has shown that OCTA provides greater detail of the order and organisation of retinal capillaries and large vessels than FA. The intervention to be administered is intravitreal aflibercept. This study will help develop ways to detect diabetic changes in the eye at an earlier stage than what is possible with current technology. OCTA data acquired from this study may aid the evaluation and treatment of diabetic retinopathy for the individual diabetic participants.
Interventions
All patients included in this study will be treated with intravitreal aflibercept therapy in the study eye. Six treatments will be given to each patient. Each treatment will be separated by an interval of 4 weeks with the exception of the 6th treatment that will be given 8 weeks after the 5th treatment. Aflibercept will be administered under sterile conditions in a dedicated treatment room using conventional intravitreal injection protocols.
The intervention is intravitreal aflibercept.
If e
All patients included in this study will be treated with intravitreal aflibercept therapy in the study eye. Six treatments will be given to each patient. Each treatment will be separated by an interval of 4 weeks with the exception of the 6th treatment that will be given 8 weeks after the 5th treatment. Aflibercept will be administered under sterile conditions in a dedicated treatment room using conventional intravitreal injection protocols. The intervention is intravitreal aflibercept. If eligible both eyes will be included. Eligibility will be confirmed by the presence of centre-involved diabetic macular oedema. Only the ophthalmologist will be administering the intravitreal aflibercept. The treatment administration will take approximately 20-30 minutes. The dose of aflibercept is 0.05mL The treatment schedule will be six treatments every four weeks over six to eight month period. The experienced study staff (orthoptist, ophthalmic imagers, clinical trial coordinators) are delegated and training is confirmed by the PI. Fluorescein angiography (FA): This test will help the PI to see the blood vessels in the patients eye so that they can be photographed. To do this test, fluorescein will be injected into a vein in the patients arm. With a special camera and flash, a series of photographs of the back of the patients eye are taken as the dye passes through it. The FA assessment will be performed by the orthoptist and PI at Visit 1 and the final visit, and will take approx. 20 minutes to complete. The Optical Coherence Tomography (OCT) and Optical Coherence Tomography Angiography (OCTA): The orthoptist/photographer will use an OCT instrument to look at the back of the patients eye in great detail and to take some pictures. This will help the PI to determine if there are any changes in the patients retina or macula, including if there are any changes in the thickness of the retina. The patient will have dilating drops administered in their eyes to make the pupil bigger and to make it easier to see the back of the eye. This assessment will occur at every visit and take approx. 45 minutes to complete.
Sponsors
Lions Eye Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age greater or equal to 18 years Type 1 or 2 diabetes mellitus Diabetic macular oedema (both treatment naive and previously treated) causing vision loss, with study eye BCVA measuring 0.3 to 1.0 logarithm of the minimum angle of resolution; macular oedema defined clinically and by retinal thickness of <250um in the central subfield; and intraretinal or subretinal fluid seen on SD-OCT.
Exclusion criteria
Another concomitant ocular disease that causes macular oedema such as age-related macular degeneration or retinal vein occlusion. Another ocular condition that compromises visual acuity, except for the presence of cataract. Previous treatment with intraocular corticosteroids within the 6 months of the baseline visit.
Outcome results
None listed