Clinical trial NCT02540954: Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
Official title: An Open-label, Randomized, Active-controlled, Parallel-group, Phase-3b Study of the Efficacy, Safety, and Tolerability of 2 mg Aflibercept Administered by Intravitreal Injections Using Two Different Treatment Regimens to Subjects With Neovascular Age-related Macular Degeneration (nAMD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Degeneration
Keywords: Age-related macular degeneration (AMD)
Eylea treatment
Treat and Extend
Intravitreal
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-09-04
Enrollment: 336
Sex: ALL
Minimum age (years): 51
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of 2 mg aflibercept administered by two different intravitreal (IVT) treatment regimens to subjects with neovascular age-related macular degeneration (nAMD)

Detailed description: 330 Patients who have completed at least one year of treatment with aflibercept will be randomized to two different aflibercept regimens and followed for 76 weeks.

Eligibility criteria: Inclusion Criteria:

* The following criteria must have been met at the initial start of aflibercept treatment (i.e. start of aflibercept treatment at least 1 year before this study):

  * Subject had primary subfoveal choroidal neovascularization (CNV) lesions secondary to nAMD, including juxtafoveal lesions that affect the fovea, as evidenced by fluorescein angiography/photography (FA/FP) of the study eye within 3 weeks before the initiation of aflibercept treatment.
  * The area of CNV occupied at least 50% of the total lesion within 3 weeks before the initiation of aflibercept treatment.
  * Documented best-corrected visual acuity (BCVA) was 20/40 to 20/320 (letter score of 73 to 25) in the study eye at the initiation of treatment.
* Men and women \>= 51 years of age
* The subject's history of aflibercept treatment meets ALL of the following:

  * Treatment in the study eye was initiated with three monthly (-1 week/+2 weeks) doses of 2 mg aflibercept and improvements of visual and anatomic outcomes were observed
  * Following the above initiation phase, the intervals between treatments were between 6 weeks and 12 weeks

Exclusion Criteria:

- Any prior or concomitant therapy with an investigational or approved agent to treat neovascular AMD in the study eye other than aflibercept.

* Total lesion size \> 12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by fluorescein angiography (FA) in the study eye
* Subretinal hemorrhage that was:

  1. 50% or more of the total lesion area, or
  2. if the blood was under the fovea, and
  3. the blood under the fovea was 1 or more disc areas in size in the study eye.
* Scar or fibrosis making up more than 50% of the total lesion in the study eye.
* Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
* Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
* Causes of CNV other than AMD in the study eye.

Primary outcomes:
measure: Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye
timeFrame: From baseline to Week 52
Secondary outcomes:
measure: Percentage of Participants Maintaining Vision in the Study Eye
timeFrame: At week 52
measure: Percentage of Participants Who Gained From Baseline 5 or More Letters in the Study Eye
timeFrame: At week 52
measure: Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
timeFrame: From baseline to week 52
measure: Mean Change From Baseline in Choroidal Neovascularization (CNV) Area in the Study Eye
timeFrame: From baseline to week 52
measure: Percentage of Participants Who Lost From Baseline 30 or More Letters in the Study Eye
timeFrame: At week 52
measure: Mean Change From Baseline in Total Score for National Eye Institute 25-Item Visual Function (NEI VFQ-25) Questionnaire
timeFrame: From baseline to week 52
measure: Number of Participants With Treatment-emergent Adverse Events (TEAE)
timeFrame: Started after the first application of aflibercept in the study and less than or equal to 30 days after the last dose of study drug over approximately 1.5 years
Other outcomes:
Locations:
city: Wien
country: Austria
city: Wien
country: Austria
city: Toronto
country: Canada
state: Ontario
city: Sherbrooke
country: Canada
facility: Clinique medicale de l'oeil de l'Estrie
state: Quebec
city: Hradec Kralove
country: Czechia
city: Plzen
country: Czechia
city: Praha 10
country: Czechia
city: Praha 2
country: Czechia
city: Praha 5
country: Czechia
city: Paris
country: France
state: Cedex 12
city: Bordeaux
country: France
city: Dijon Cedex
country: France
city: Lyon Cedex 04
country: France
city: Nice Cedex
country: France
city: Paris
country: France
city: Würzburg
country: Germany
state: Bayern
city: Darmstadt
country: Germany
state: Hessen
city: Frankfurt
country: Germany
state: Hessen
city: Marburg
country: Germany
state: Hessen
city: Göttingen
country: Germany
state: Niedersachsen
city: Düsseldorf
country: Germany
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
state: Sachsen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Pecs
country: Hungary
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Genova
country: Italy
state: Liguria
city: Brescia
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Torino
country: Italy
state: Piemonte
city: Catania
country: Italy
state: Sicilia
city: Pisa
country: Italy
state: Toscana
city: Verona
country: Italy
state: Veneto
city: Parma
country: Italy
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: Gdansk
country: Poland
city: Olsztyn
country: Poland
city: Coimbra
country: Portugal
city: Leiria
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Nitra
country: Slovakia
city: L'Hospitalet de Llobregat
country: Spain
state: Barcelona
city: Barcelona
country: Spain
city: Valencia
country: Spain
city: Bern
country: Switzerland
city: Genève
country: Switzerland
city: Southampton
country: United Kingdom
state: Hampshire
city: Liverpool
country: United Kingdom
state: Merseyside
city: Great Yarmouth
country: United Kingdom
state: Norfolk
city: Middlesborough
country: United Kingdom
state: North Yorkshire
city: Pontyclun
country: United Kingdom
state: Rhondda, Cynon, Taff
city: Guildford
country: United Kingdom
state: Surrey
city: Newcastle Upon Tyne
country: United Kingdom
state: Tyne And Wear
city: Sunderland
country: United Kingdom
state: Tyne And Wear
city: Rugby
country: United Kingdom
state: Warwickshire
city: Wakefield
country: United Kingdom
state: West Yorkshire
city: Hull
country: United Kingdom
state: York
city: Colchester
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: