Wet Age-related Macular Degeneration
Conditions
Brief summary
The purpose of this observational study lies in the analysis of a treat-and-extend injection scheme with intravitreal aflibercept (i.e. injection into the eye), as applied in routine practice in previously untreated patients diagnosed with wet age-related macular degeneration.
Detailed description
Data will be collected from the medical files retro- and prospectively. If patients are still under treatment at study initiation and have not yet completed 24 months of treatment with intravitreal aflibercept in a treat-and-extend regimen, data of the remaining observation period will be collected prospectively.
Interventions
Intravitreal aflibercept injections used in a routine treat and extend regimen, under which the intervals between the injections are extended if disease stability is maintained and no signs of worsening disease are observed on the injection day
Sponsors
Regeneron Pharmaceuticals
Bayer
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of wet age-related macular degeneration. * No prior therapy for wet age-related macular degeneration. * Patients for whom the decision to initiate treatment with IVT-AFL in a T&E regimen was made as per routine clinical practice. * Patient age \>55 years of age
Exclusion criteria
* Participation in an investigational program with therapeutical interventions outside of clinical routine practice. * Patients with eye diseases e.g. advanced glaucoma or visually significant cataracts, likely to require surgery during the observation period in the study eye. * Concomitant ocular or systemic administration of drugs up to 3 months before commencement of IVT-AFL treatment that could interfere with or potentiate the mechanism of action of aflibercept, including anti-VEGF agents. This includes patients receiving a different anti-VEGF agent for the fellow eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in best-corrected visual acuity in Early Treatment Diabetic Retinopathy Study letters (ETDRS letters) | Baseline and at 12 months | mean change in ETDRS letters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in best-corrected visual acuity (in Early Treatment Diabetic Retinopathy Study (ETDRS) letters) | Baseline and at 24 months | mean change in ETDRS letters |
| Mean change in best-corrected visual acuity in relation to the number of injections administered | Baseline and at 12 months; Baseline and at 24 months | Numbers of injections will be predefined as categories and analyzed in relation to the BCVA changes |
| Reasons for the interval length | At 12 and 24 months | morphology and / or BCVA /other |
| Frequency of disease reactivation | Baseline and at 12 months; Baseline and at 24 months | Disease activity such as hemorrhage, PED, subretinal fluid, cystoid intraretinal fluid, RPE rip assessed at the investigator's discretion as: none / new or increasing / decreasing / stable |
| Mean interval between injections | At 12 and 24 months | mean interval displayed in weeks or days |
| Mean changes from baseline in central retinal thickness (CRT) | Baseline and at 3 months; Baseline and at 12 months; Baseline and 24 months | micro meter (µm) |
| Changes from baseline in retinal fluid | Baseline and at 12 months; Baseline and at 24 months | intraretinal or subretinal fluid or pigment epithelial detachment (PED) |
| Reasons for termination of therapy (including subsequent therapy at time of discontinuation) | At 12 and 24 months | Categorized into typical reasons for discontinuation such as e.g. death, lost to Follow-up, withdrawal of informed consent, change of treatment regimen, discontinuation of IVT-AFL treatment, interfering surgery or treatment, adverse event, other |
| Severity of disease reactivation | Baseline and at 12 months; Baseline and at 24 months | Severity of disease reactivation assessed at the investigator's discretion as: no new disease activity / mild / severe |
| Proportion of eyes gaining or losing ≥ 15 Early Treatment Diabetic Retinopathy Study letters compared to baseline | Baseline and at 12 months; Baseline and at 24 months | Proportion evaluated as percentage (%) of eyes |
Countries
Switzerland
Outcome results
None listed