This prospective, observational, open-label study evaluates early treatment response to intravitreal aflibercept 8 mg in patients with exudative age-related macular degeneration. Retinal fluid dynamics assessed by optical coherence tomography and changes in best-corrected visual acuity two months after baseline are analyzed to characterize early treatment outcomes.
Evidence of SRF and/or IRF and
area of fibrosis less than 50% of the lesion area. BCVA scores at both screening and baseline must be 23 letters or more as measured by the ETDRS-like charts (or approximate Snellen equivalent to 20/320).
Inability to comply with study or follow-up procedures.
Pregnant or nursing (lactating) women.
Women of child-bearing potential, not using or not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the Investigator in individual cases. (Female participants who are surgically sterilised/hysterectomised, or post-menopausal for longer than 2 years are not considered as being of child-bearing potential.)
Any type of systemic disease or its treatment, in the opinion of the Investigator, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.
treatment naïve patients with diagnosis of wAMD with SRF
Cohort
Prospective
treatment with Aflibercept 8mg (Eylea)
Drugintravitreal injection of 8mg aflibercept
Fluid dynamics on OCT scans during the early treatment phase of macular degeneration with Aflibercept 8mg.
Change in fluid levels of intraretinal fluid (IRF), subretinale fluid (SRF) and sub retinal pigment epithelium fluid (subRPE fluid) will be analyzed using an AI based software tool on macular OCT-scans during the first two months of treatment with aflibercept 8mg. Fluid volumes will be quantified for each available OCT scan and represented as Nanoliters (nL). The analysis will return quantitative values for the OCT scan as a whole and also for each subfield of the ETDRS-Grid (Early-Treatment-Diabetic-Retinopathy-Study).
Proportion of patients without disease activity at month 2 after treatment start
At the final study visit, two months after treatment initiation, disease activity is assessed. Patients are considered disease-free if they show no intraretinal fluid (IRF) or no subretinal fluid (SRF) on OCT imaging.
Prediction of Annual Treatment Demand in nAMD Patients at 12 Months
The annual treatment demand is defined as the total number of intravitreal injections administered to patients with neovascular age-related macular degeneration (nAMD) within the first 12 months following the initial injection. To predict this demand early in the treatment course, a predictive model is being developed based on early OCT features and clinical parameters obtained at baseline and during the initial treatment phase. As the 12-month endpoint extends beyond the primary study period, this outcome requires additional follow-up data outside the core study timeframe. This extended follow-up does not necessitate additional study visits, as the information is obtained from routine clinical records.
Best-Corrected Visual Acuity (BCVA) Outcomes at Two Months Post-Treatment
Best-corrected visual acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) charts and recorded as the total number of letters read correctly. Measurements were taken at baseline, at multiple timepoints throughout the study, and at the final visit two months after treatment initiation. The change in BCVA from baseline to the final visit was then evaluated to determine whether visual acuity had improved.
Click on the lead sponsor to view all of their trials.
