Observational Study to Assess Intravitreal Aflibercept Injections Used in a "Treat and Extend" Regimen in Treatment-naïve Wet Age-related Macular Degeneration Patients

Wet Age-related Macular Degeneration Clinical Trial

— ASTERIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382587
• Other study ID #: 18574
• Status: Completed
• Start date: December 5, 2017
• Est. completion date: November 27, 2018

Study information

• Verified date: June 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: November 27, 2018
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Age-related Macular Degeneration

Intervention

Drug:
• Aflibercept (Eylea, BAY86-5321)
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

Locations

Country	Name	City	State
Switzerland	Many Locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in best-corrected visual acuity in Early Treatment Diabetic Retinopathy Study letters (ETDRS letters)	mean change in ETDRS letters	Baseline and at 12 months
Secondary	Mean change from baseline in best-corrected visual acuity (in Early Treatment Diabetic Retinopathy Study (ETDRS) letters)	mean change in ETDRS letters	Baseline and at 24 months
Secondary	Mean change in best-corrected visual acuity in relation to the number of injections administered	Numbers of injections will be predefined as categories and analyzed in relation to the BCVA changes	Baseline and at 12 months; Baseline and at 24 months
Secondary	Mean interval between injections	mean interval displayed in weeks or days	At 12 and 24 months
Secondary	Reasons for the interval length	morphology and / or BCVA /other	At 12 and 24 months
Secondary	Frequency of disease reactivation	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	Baseline and at 12 months; Baseline and at 24 months
Secondary	Proportion of eyes gaining or losing = 15 Early Treatment Diabetic Retinopathy Study letters compared to baseline	Proportion evaluated as percentage (%) of eyes	Baseline and at 12 months; Baseline and at 24 months
Secondary	Mean changes from baseline in central retinal thickness (CRT)	micro meter (µm)	Baseline and at 3 months; Baseline and at 12 months; Baseline and 24 months
Secondary	Changes from baseline in retinal fluid	intraretinal or subretinal fluid or pigment epithelial detachment (PED)	Baseline and at 12 months; Baseline and at 24 months
Secondary	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, other	At 12 and 24 months
Secondary	Severity of disease reactivation	Severity of disease reactivation assessed at the investigator's discretion as: no new disease activity / mild / severe	Baseline and at 12 months; Baseline and at 24 months

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