None listed
Conditions
Brief summary
Peripheral retinal ischaemia is strongly associated with the presence and severity of diabetic macular oedema (DMO), and ultra-widefield fluorescein angiography (UWF-FA) has demonstrated that peripheral non-perfusion is a key feature in eyes at risk of vision loss. Previous work (Hein et al., 2023) found that intravitreal aflibercept 2mg did not reverse or prevent progression of capillary non-perfusion in eyes with DMO. High-dose intravitreal aflibercept 8 mg has recently been approved and funded (TGA-approved and PBS-listed) for treatment of DMO, and is now used as standard-of-care in appropriate patients at our centre. Clinical trial and real-world data indicate that aflibercept 8 mg provides robust efficacy with a safety profile comparable to aflibercept 2 mg in DMO, with the potential to improve disease control and reduce treatment burden through extended dosing intervals. Given the greater pharmacodynamic effect of the 8 mg dose, it is plausible that aflibercept 8 mg may attenuate the natural course of retinal ischaemia progression in patients receiving treatment for DMO; however, its impact on retinal non-perfusion has not yet been systematically characterised.
Interventions
We would be enrolling patients who would have gotten 8mg Aflibercept regardless of participation in the study. Aflibercept 8mg as a part of standard of care in the hospital
Drug: Aflibercept
Dose: 8mg
Duration: Monthly injections for 6 months
Mode of Delivery: Intravitreal injection administered by an ophthalmologist
Adherence: monthly appointments booked with the patient for administration of the injection. Duration of each of each of these appointments will be under 2 hours,
Imaging sch
We would be enrolling patients who would have gotten 8mg Aflibercept regardless of participation in the study. Aflibercept 8mg as a part of standard of care in the hospital Drug: Aflibercept Dose: 8mg Duration: Monthly injections for 6 months Mode of Delivery: Intravitreal injection administered by an ophthalmologist Adherence: monthly appointments booked with the patient for administration of the injection. Duration of each of each of these appointments will be under 2 hours, Imaging schedule: First visit and final visit (6 months from the first visit) - Ultra-widefield (UWF) Optical Coherence Tomography (OCT) fluorescein angiography (FA), Ultra-widefield Optical Coherence Tomography (UWF-OCT), spectral-domain OCT (SD-OCT), Optical Coherence Tomography Angiography (OCT-A) macula, Ultra-widefield fundus imaging Monthly visits - UWF OCT, OCT macula, Ultra-widefield fundus imaging. fluorescein dye is only used in the first and the final visit. Duration: The imaging would take up to 2 hours.
Sponsors
Prof. Chandra Balaratnasingam, Lions Eye Institute
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
•Adults (greater than or equal to 18 years) with type 1 or type 2 diabetes. Centre-involving DMO requiring anti-Vascular Endothelial Growth Factor (anti-VEGF) therapy. • Best-corrected visual acuity (BCVA) 20/25–20/320 (ETDRS). • Able and willing to consent for the study, complete all required imaging and follow-up visits.
Exclusion criteria
• Pregnant or breastfeeding women, or women planning pregnancy during the study period or within 3 months after the last aflibercept 8 mg injection, because the safety of intravitreal anti-VEGF agents in pregnancy is uncertain and these drugs can reduce circulating VEGF, which is important for fetal development (10). If a participant becomes pregnant or is found to be pregnant during the study, study treatment with intravitreal aflibercept will be stopped as soon as pregnancy is identified, and the participant will be withdrawn from the interventional component of the study. • Prior intraocular surgery or pan-retinal photocoagulation (PRP) within 3 months of baseline. • Active proliferative diabetic retinopathy (PDR) requiring immediate PRP. • Macular ischaemia due to causes other than diabetic retinopathy. • Significant media opacity precluding quality imaging. • Uncontrolled glaucoma – confirmed decline in visual function over time even after starting on >2 IOP lowering medication. • Any other cause of retinal vascular disease such as retinal vein occlusion. • Previous treatment for DMO within 6 months of screening visit including intravitreal anti-VEGF/corticosteroids or macular laser.
Outcome results
None listed