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

Macular Degeneration Clinical Trial

— ARIES  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02581891
• Other study ID #: 17508
• Secondary ID: 2014-003132-39
• Status: Completed
• Phase: Phase 4
• Start date: November 19, 2015
• Est. completion date: April 26, 2019

Study information

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

Clinical Trial Summary

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

Description:

The T&E dosing regimen for nAMD has emerged as a preferred regimen for many treating physicians aiming at maximizing outcomes by proactively treating the subject at each visit and by extending the treatment interval (if extension criteria are met), thus limiting visits, monitoring, and injections.

To this day, there is limited evidence available addressing the question of what are useful intervals for treating and monitoring, how do they differ among subjects, and how are retreatment criteria applied to achieve long-term desirable outcomes in real-life practice. This study is designed to evaluate the optimal use, efficacy, and safety of the T&E regimen with intravitreal aflibercept in subjects with nAMD.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: April 26, 2019
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)
3 monthly doses followed by individualized treatment intervals of between 8 to16 weeks based on protocol-defined anatomical criteria
• Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)
3 monthly doses followed by five 8-weekly doses (5 x 2Q8), then by individualized treatment intervals of between 8 to 16 weeks based on protocol-defined anatomical criteria

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Canada,  France,  Germany,  Hungary,  Italy,  Spain,  United Kingdom, 

References & Publications (3)

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-Relate — View Citation

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: — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 104 Compared With Baseline	Participants maintained 3 lines (15 letters) vision loss in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter.	at Week 104
Secondary	Change in BCVA From Baseline to Week 52, Baseline to Week 104, and Week 16 to Week 52	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 baseline to Week 52, baseline to Week 104, and Week 16 to Week 52
Secondary	Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 52 Compared With Baseline	Participants maintained 3 lines (15 letters) vision loss in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter.	At week 52
Secondary	Percentage of Participants Gained 3-line at Week 52 and Week 104 Compared With Baseline	Participants gained 3 lines (15 letters) in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter.	At Week 52 and Week 104
Secondary	Change in Central Retinal Thickness (CRT)	CRT were evaluated using spectral domain Optical coherence tomograph (OCT).	From baseline to Week 52, baseline to Week 104, Week 16 to Week 52, and Week 16 to Week 104
Secondary	Number of Study Drug Injections From Baseline to Week 52 and Baseline to Week 104		At Week 52 and Week 104
Secondary	Duration of Last Treatment Interval		Early-Start T&E: from week 16 up to Week 104 or early termination; Late-Start T&E: From end of Year 1 up to Week 104 or early termination
Secondary	Percentage of Participants Requiring Retreatment at 8 Weeks, 10 Weeks, 12 Weeks, 14 Weeks, and 16 Weeks as the Last Treatment Interval		at 8 weeks, 10 weeks, 12 weeks, 14 weeks, and 16 weeks

External Links

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