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

NCT02581891 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 175082014-003132-39
• Study Type: interventional
• Target: 287
• Locations: 8 countries
• Sites: 39

Brief Summary

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

Conditions

Macular Degeneration

Keywords

Neovascular age-related macular degeneration; nAMD)

Outcome Measures

Primary Outcomes (1)

• Change in BCVA as Measured by the ETDRS Letter Score

  BCVA (best corrected visual acuity) was measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 25 (= Acuity of 20/40 to 20/320) in the study eye at 4 meters; a higher score represents better functioning.

  From Week 16 to Week 104

Secondary Outcomes (8)

• Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 104 Compared With Baseline

  at Week 104

• Change in BCVA From Baseline to Week 52, Baseline to Week 104, and Week 16 to Week 52

  from baseline to Week 52, baseline to Week 104, and Week 16 to Week 52

• Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 52 Compared With Baseline

  At week 52

• Percentage of Participants Gained 3-line at Week 52 and Week 104 Compared With Baseline

  At Week 52 and Week 104

• Change in Central Retinal Thickness (CRT)

  From baseline to Week 52, baseline to Week 104, Week 16 to Week 52, and Week 16 to Week 104

Study Arms (2)

Early-start T&E / Arm 1

EXPERIMENTAL

Early-start T\&E arm: test group, early treatment individualization

Drug: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)

Late-start T&E / Arm 2

ACTIVE COMPARATOR

Late-start T\&E arm; per label, control group, treatment individualization after Year 1

Drug: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)

Interventions

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

3 monthly doses followed by individualized treatment intervals of between 8 to16 weeks based on protocol-defined anatomical criteria

Early-start T&E / Arm 1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (39)

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Strathfield, New South Wales, 2135, Australia

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Sydney, New South Wales, 2000, Australia

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Westmead, New South Wales, 2145, Australia

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East Melbourne, Victoria, 3002, Australia

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Launceston, 7249, Australia

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Hamilton, Ontario, L8G 5E4, Canada

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Ottawa, Ontario, K2B7E9, Canada

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Boisbriand, Quebec, J7H1S6, Canada

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Créteil, 94010, France

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Nice, 06006, France

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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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Tübingen, Baden-Wurttemberg, 72076, Germany

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Hanover, Lower Saxony, 30625, Germany

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Bonn, North Rhine-Westphalia, 53105, Germany

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Cologne, North Rhine-Westphalia, 50924, Germany

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Sulzbach, Saarland, 66280, Germany

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Chemnitz, Saxony, 09116, Germany

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Berlin, 10713, Germany

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Budapest, 1062, Hungary

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Budapest, 1085, Hungary

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Budapest, 1106, Hungary

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Budapest, 1115, Hungary

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Budapest, 1125, Hungary

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Budapest, 1133, Hungary

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Debrecen, 4032, Hungary

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Pécs, 7621, Hungary

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Szombathely, 9700, Hungary

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Rome, Lazio, 00198, Italy

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Milan, Lombardy, 20132, Italy

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Milan, Lombardy, 20157, Italy

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Padua, Veneto, 35128, Italy

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Oviedo, Principality of Asturias, 33012, Spain

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Madrid, Spain

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Zaragoza, 50009, Spain

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Canterbury, Kent, CT1 3NG, United Kingdom

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Bristol, BS12LX, United Kingdom

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Liverpool, L7 8XP, United Kingdom

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London, EC1V2PD, United Kingdom

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Oxford, OX3 9DU, United Kingdom

Location

Related Publications (5)

• Wolf S, Holz FG, Midena E, Souied EH, Lambrou G, Machewitz T, Allmeier H, Mitchell P; ARIES Study Investigators. Patients with Neovascular Age-Related Macular Degeneration Requiring Intensive Intravitreal Aflibercept Treatment: An ARIES Post Hoc Analysis. Ophthalmol Ther. 2022 Oct;11(5):1793-1803. doi: 10.1007/s40123-022-00541-8. Epub 2022 Jul 12.

  PMID: 35821380 RESULT

• Chaudhary V, Holz FG, Wolf S, Midena E, Souied EH, Allmeier H, Lambrou G, Machewitz T, Mitchell P; ARIES study investigators. Association Between Visual Acuity and Fluid Compartments with Treat-and-Extend Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration: An ARIES Post Hoc Analysis. Ophthalmol Ther. 2022 Jun;11(3):1119-1130. doi: 10.1007/s40123-022-00491-1. Epub 2022 Mar 18.

  PMID: 35303285 RESULT

• Tuerksever C, Somfai GM, Oesch S, Machewitz T, Hasler PW, Zweifel S. Hypothetical Switch of Anti-Vascular Endothelial Growth Factor in Neovascular Age-Related Macular Degeneration: An ARIES Post Hoc Analysis. Ophthalmol Ther. 2022 Apr;11(2):613-627. doi: 10.1007/s40123-021-00448-w. Epub 2022 Jan 23.

  PMID: 35066801 RESULT

• Krieger N, Chen JT, Testa C, Diez Roux A, Tilling K, Watkins S, Simpkin AJ, Suderman M, Davey Smith G, De Vivo I, Waterman PD, Relton C. Use of Correct and Incorrect Methods of Accounting for Age in Studies of Epigenetic Accelerated Aging: Implications and Recommendations for Best Practices. Am J Epidemiol. 2023 May 5;192(5):800-811. doi: 10.1093/aje/kwad025.

  PMID: 36721372 DERIVED

• Mitchell P, Holz FG, Hykin P, Midena E, Souied E, Allmeier H, Lambrou G, Schmelter T, Wolf S; ARIES study investigators. EFFICACY AND SAFETY OF INTRAVITREAL AFLIBERCEPT USING A TREAT-AND-EXTEND REGIMEN FOR NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: The ARIES Study: A Randomized Clinical Trial. Retina. 2021 Sep 1;41(9):1911-1920. doi: 10.1097/IAE.0000000000003128.

  PMID: 33782365 DERIVED

Related Links

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

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

(+) 1-888-8422937

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 21, 2015
• Study Start: November 19, 2015
• Primary Completion: April 26, 2019
• Study Completion: April 26, 2019
• Last Updated: November 8, 2023
• Results First Posted: May 21, 2020

Record last verified: 2023-11

Locations

GB (5); ES (3); DE (8); HU (9); CA (3); FR (2); IT (4); AU (5)