Study Completed

Wet age-related macular degeneration

Bayer Identifier:

18574

ClinicalTrials.gov Identifier:

NCT03382587

EudraCT Number:

Not Available

EU CT Number:

Not Available

Observational study to assess intravitreal aflibercept injections used in a “treat and extend” regimen in treatment-naïve wet age-related macular degeneration patients

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.

Key Participants Requirements

Sex

All

Age

55 - N/A

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

163

Trial Dates

December 2017 - November 2018

Phase

N/A

Could I Receive a placebo

Products

Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Many Locations	Many Locations, Switzerland

Primary Outcome

Mean change from baseline in best-corrected visual acuity in Early Treatment Diabetic Retinopathy Study letters (ETDRS letters)
mean change in ETDRS letters
Time Frame:
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 letters
Time Frame:
Baseline and at 24 months
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
Time Frame:
Baseline and at 12 months; Baseline and at 24 months
Mean interval between injections
mean interval displayed in weeks or days
Time Frame:
At 12 and 24 months
Reasons for the interval length
morphology and / or BCVA /other
Time Frame:
At 12 and 24 months
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
Time Frame:
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 baseline
Proportion evaluated as percentage (%) of eyes
Time Frame:
Baseline and at 12 months; Baseline and at 24 months
Mean changes from baseline in central retinal thickness (CRT)
micro meter (µm)
Time Frame:
Baseline and at 3 months; Baseline and at 12 months; Baseline and 24 months
Changes from baseline in retinal fluid
intraretinal or subretinal fluid or pigment epithelial detachment (PED)
Time Frame:
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, other
Time Frame:
At 12 and 24 months
Severity of disease reactivation
Severity of disease reactivation assessed at the investigator’s discretion as: no new disease activity / mild / severe
Time Frame:
Baseline and at 12 months; Baseline and at 24 months

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

N/A

Additional Information

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