Age-Related Macular Degeneration (AMD)
Conditions
Keywords
neovascular macular degeneration, Aflibercept, Eylea
Brief summary
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.
Detailed description
This prospective, observational, open-label study investigates early anatomical and functional responses to intravitreal aflibercept 8 mg in patients with exudative age-related macular degeneration (AMD). The primary focus is on retinal fluid dynamics during the initial treatment phase, assessed by macular optical coherence tomography (OCT). Changes in intraretinal fluid, subretinal fluid, and sub-retinal pigment epithelium (sub-RPE) fluid levels are evaluated over the first two months of treatment. In addition, the frequency of detection of hyperreflective retinal foci (HRF) and complete retinal pigment epithelium and outer retinal atrophy (cRORA) on OCT scans is assessed during this period. Functional outcomes are evaluated by changes in best-corrected visual acuity (BCVA), measured using ETDRS charts, two months after baseline. Furthermore, the proportion of patients without signs of disease activity at two months is determined. Early anatomical and functional responses observed during the first two months are analyzed to explore their potential value in predicting treatment demand over the first year of therapy.
Interventions
DRUGtreatment with Aflibercept 8mg (Eylea)
intravitreal injection of 8mg aflibercept
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of subfoveal CNV secondary to wAMD without restriction of lesion size. Active wAMD lesions are characterised by the following: * 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). Only one eye (the study eye) will be treated with study drug. If both eyes are eligible at screening and baseline, the eye with the lower VA will be defined as the study eye. If both eyes are eligible and VA is the same for both eyes, the Investigator will chose the study eye based on clinical judgment.
Exclusion criteria
* The presence of any one of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluid dynamics on OCT scans during the early treatment phase of macular degeneration with Aflibercept 8mg. | Each participant is followed up for 2 months after their treatment with aflibercept 8mg. From study enrollment and the 1st injection, over weekly check ups until the 2nd injection, completed with a last visit and the 3rd and last injection. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients without disease activity at month 2 after treatment start | Each participant is followed up for 2 months after their treatment initiation with aflibercept 8mg | 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 | Each participant is followed up for two months within the study protocol. For the prediction of annual treatment demand, additional data on the total number of injections up to 12 months after the initial injection are required, without extra study visit | 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 | Each participant is followed up for 2 months after their treatment with aflibercept 8mg. | 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. |
Countries
Switzerland
Contacts
CONTACTFlorian M Heussen, Dr. med.
CONTACTMartin S Zinkernagel, Prof. Dr. Dr. med.
PRINCIPAL_INVESTIGATORFlorian M Heussen, Dr. med.
Dept. of Ophthalmology, University Hospital, Inselspital
Outcome results
None listed