Trial Condition(s):
Wet age-related macular degeneration
Observational study to assess intravitreal aflibercept injections used in a “treat and extend” regimen in treatment-naïve wet age-related macular degeneration patients (ASTERIA)
Bayer Identifier:
18574
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many Locations Many Locations, Switzerland | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
An observational study to assess the use of intravitreal aflibercept injections in a routine “treat and extend” regimen in treatment-naïve patients diagnosed with wet age-related macular degeneration
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Mean change from baseline in best-corrected visual acuity in Early Treatment Diabetic Retinopathy Study letters (ETDRS letters)mean change in ETDRS lettersTimeframe: Baseline and at 12 months
Secondary Outcome
- Mean change from baseline in best-corrected visual acuity (in Early Treatment Diabetic Retinopathy Study (ETDRS) letters)mean change in ETDRS lettersTimeframe: Baseline and at 24 months
- Mean change in best-corrected visual acuity in relation to the number of injections administeredNumbers of injections will be predefined as categories and analyzed in relation to the BCVA changesTimeframe: Baseline and at 12 months; Baseline and at 24 months
- Mean interval between injectionsmean interval displayed in weeks or daysTimeframe: At 12 and 24 months
- Reasons for the interval lengthmorphology and / or BCVA /otherTimeframe: At 12 and 24 months
- Frequency of disease reactivationDisease activity such as hemorrhage, PED, subretinal fluid, cystoid intraretinal fluid, RPE rip assessed at the investigator’s discretion as: none / new or increasing / decreasing / stableTimeframe: Baseline and at 12 months; Baseline and at 24 months
- Proportion of eyes gaining or losing ≥ 15 Early Treatment Diabetic Retinopathy Study letters compared to baselineProportion evaluated as percentage (%) of eyesTimeframe: Baseline and at 12 months; Baseline and at 24 months
- Mean changes from baseline in central retinal thickness (CRT)micro meter (µm)Timeframe: Baseline and at 3 months; Baseline and at 12 months; Baseline and 24 months
- Changes from baseline in retinal fluidintraretinal or subretinal fluid or pigment epithelial detachment (PED)Timeframe: Baseline and at 12 months; Baseline and at 24 months
- Reasons for termination of therapy (including subsequent therapy at time of discontinuation)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, otherTimeframe: At 12 and 24 months
- Severity of disease reactivationSeverity of disease reactivation assessed at the investigator’s discretion as: no new disease activity / mild / severeTimeframe: Baseline and at 12 months; Baseline and at 24 months
Additional Information
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