Study Completed

Macular degeneration

Bayer Identifier:

17508

ClinicalTrials.gov Identifier:

NCT02581891

EudraCT Number:

2014-003132-39

EU CT Number:

Not Available

Managing neovascular (known as "wet") age-related macular degeneration over 2 years using different treatment schedules of 2 mg intravitreal aflibercept injected in the eye

Trial purpose

This study aims to evaluate the optimal use, efficacy, and safety of a Treat-and-Extend regimen with aflibercept in subjects with nAMD.

Key Participants Requirements

Sex

Both

Age

50 - N/A

Inclusion Criteria
- Men and women ≥ 50 years of age.
- Active primary subfoveal CNV lesions secondary to nAMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye. Patients with polypoidal choroidal vasculopathy or retinal angiomatous proliferation are eligible to participate in the study, and their condition should be captured in the eCRF.
- ETDRS BCVA of 73 to 25 letters (20/40 to 20/320 Snellen equivalent) in the study eye.
- The area of CNV must occupy at least 50% of the total lesion.
Exclusion Criteria
- Any prior ocular (in the study eye) or systemic treatment or surgery for nAMD, except dietary supplements or vitamins.
- Any prior or concomitant therapy with another investigational agent to treat nAMD in the study eye.
- Prior treatment with anti-VEGF agents as follows:
- Prior treatment with anti-VEGF therapy in the study eye is not allowed
- Prior treatment with anti-VEGF therapy in the fellow eye with an investigational agent (not approved, e.g. bevacizumab) within the last 3 months before the first dose in the study. Such treatment will also not be allowed during the study. Prior treatment with an approved anti-VEGF therapy in the fellow eye is allowed.
- Prior systemic anti-VEGF therapy, investigational or approved, within the last 3 months before the first dose in the study, and such treatment will not be allowed during the study.
- Total lesion size >12 disc areas (30.5 mm2, including blood, scars and neovascularization) as assessed by FA in the study eye.
- Subretinal hemorrhages that are either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye. (If the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
- Scar or fibrosis making up >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.

Trial summary

Enrollment Goal

287

Trial Dates

November 2015 - April 2019

Phase

Phase 4

Could I Receive a placebo

Products

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

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Ottawa, K2B7E9, Canada
Completed		Boisbriand, J7H1S6, Canada
Withdrawn		Toronto, M5C 2T2, Canada
Completed		Padova, 35128, Italy
Completed		Roma, 00198, Italy
Completed		Milano, 20132, Italy
Completed		Milano, 20157, Italy
Completed		Hannover, 30625, Germany
Completed		Köln, 50924, Germany
Completed		Tübingen, 72076, Germany
Completed		Freiburg, 79106, Germany
Completed		Sulzbach, 66280, Germany
Completed		Bonn, 53105, Germany
Completed		Oviedo, 33012, Spain
Completed		Zaragoza, 50009, Spain
Completed		Madrid, Spain
Completed		Westmead, 2145, Australia
Completed		Sydney, 2000, Australia
Completed		East Melbourne, 3002, Australia
Completed		Liverpool, L7 8XP, United Kingdom
Completed		Bristol, BS12LX, United Kingdom
Completed		London, EC1V2PD, United Kingdom
Completed		Oxford, OX3 9DU, United Kingdom
Withdrawn		Belfast, BT12 6BA, United Kingdom
Completed		Launceston, 7249, Australia
Completed		CRETEIL CEDEX, 94010, France
Completed		Nice cedex 1, 06006, France
Withdrawn		Drummondville, J2C 2C4, Canada
Withdrawn		NIJMEGEN, 6525 EX, Netherlands
Withdrawn		GRONINGEN, 9713 GZ, Netherlands
Withdrawn		Bolton, BL4 0JR, United Kingdom
Completed		Canterbury, CT1 3NG, United Kingdom
Completed		Chemnitz, 09116, Germany
Completed		Hamilton, L8G 5E4, Canada
Completed		Berlin, 10713, Germany
Completed		Strathfield, 2135, Australia
Completed		Pecs, 7621, Hungary
Completed		Budapest, 1085, Hungary
Completed		Debrecen, 4032, Hungary
Completed		Budapest, 1133, Hungary
Completed		Budapest, 1106, Hungary
Completed		Budapest, 1115, Hungary
Completed		Budapest, 1062, Hungary
Completed		Szombathely, 9700, Hungary
Completed		Budapest, 1125, Hungary

Primary Outcome

Change in best corrected visual acuity (BCVA) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Time Frame:
Week 104
Safety Issue:
No

Secondary Outcome

Proportion of subjects maintaining vision (<3 lines loss)
Time Frame:
Weeks 52 and 104
Safety Issue:
No
Change in BCVA as measured by the ETDRS letter score
Time Frame:
Weeks 52 and 104
Safety Issue:
No
Change in central retinal thickness (CRT)
Time Frame:
Weeks 52 and 104
Safety Issue:
No
Number of study drug injections
Time Frame:
Weeks 52 and 104
Safety Issue:
No
Duration of last re-treatment interval
Time Frame:
Week 104
Safety Issue:
No
Proportion of subjects requiring retreatment at 8, 10, 12, 14, and 16 weeks as the last treatment interval
Time Frame:
Week 104
Safety Issue:
No
Proportion of 3-line vision gainers
Time Frame:
Weeks 52 and 104
Safety Issue:
No

Trial design

Managing neovascular age-related macular degeneration (nAMD) over 2 years with a Treat and Extend (T&E) regimen of 2 mg intravitreal aflibercept - a randomized, open-label, active-controlled, parallel-group phase IV/IIIb study (ARIES)

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

Randomized

Blinding

Open Label

Assignment

Parallel Assignment

Trial Arms

Additional Information

Click here to find further information and, after study completion, the study results according to Bayer's transparency standards