Who is sponsoring NCT02581891?

NCT02581891 is sponsored by Bayer.

What drugs are being tested in NCT02581891?

Interventions in NCT02581891: Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321), Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321).

What condition does NCT02581891 study?

NCT02581891 studies Macular Degeneration.

Is NCT02581891 still recruiting?

NCT02581891 is currently completed. Last updated 8 November 2023.

Are results published for NCT02581891?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-11-08 · How we verify

NCT02581891: ARIES

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Results posted Last updated 8 November 2023

What this trial tests

Phase 4 trial testing Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321) in Macular Degeneration in 287 participants. Completed in 26 April 2019.

Timeline

19 November 2015

Primary endpoint
26 April 2019

26 April 2019

Quick facts

Lead sponsor	Bayer
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	287
Start date	19 November 2015
Primary completion	26 April 2019
Estimated completion	26 April 2019
Sites	39 locations across France, Italy, United Kingdom, Germany, Hungary, Canada, Australia, Spain

Drugs / interventions tested

Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321) — full drug profile →
Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321) — full drug profile →

Conditions studied

Macular Degeneration — all drugs for Macular Degeneration →

Sponsor

Bayer — full company profile →

Who can join

50 and older, any sex, with Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in BCVA as Measured by the ETDRS Letter Score Primary · From Week 16 to Week 104

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.

Group	Value	95% CI
Early-start T&E Arm	-2.1	± 11.4
Late-start T&E Arm	-0.4	± 8.4

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

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.

Group	Value	95% CI
Early-start T&E Arm	93.4
Late-start T&E Arm	96.2

Change in BCVA From Baseline to Week 52, Baseline to Week 104, and Week 16 to Week 52 Secondary · from baseline to Week 52, baseline to Week 104, and Week 16 to Week 52

From baseline to Week 52

Group	Value	95% CI
Early-start T&E Arm	7.8	± 9.4
Late-start T&E Arm	10.2	± 9.3

From baseline to Week 104

Group	Value	95% CI
Early-start T&E Arm	4.3	± 13.4
Late-start T&E Arm	7.9	± 11.9

Week 16

Group	Value	95% CI
Early-start T&E Arm	66.7	± 13.0
Late-start T&E Arm	69.6	± 11.6

From Week 16 to Week 52

Group	Value	95% CI
Early-start T&E Arm	1.3	± 6.4
Late-start T&E Arm	2.0	± 5.3

Percentage of Participants Maintaining Vision (<3 Lines Loss) at Week 52 Compared With Baseline Secondary · At week 52

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.

Group	Value	95% CI
Early-start T&E Arm	100.0
Late-start T&E Arm	100.0

Percentage of Participants Gained 3-line at Week 52 and Week 104 Compared With Baseline Secondary · At Week 52 and Week 104

Participants gained 3 lines (15 letters) in BCVA (Best-corrected visual acuity) as measured by the ETDRS (Early Treatment Diabetic Retinopathy Study) letter.

Week 52

Group	Value	95% CI
Early-start T&E Arm	19.8
Late-start T&E Arm	27.9

Week 104

Group	Value	95% CI
Early-start T&E Arm	18.9
Late-start T&E Arm	22.1

Change in Central Retinal Thickness (CRT) Secondary · From baseline to Week 52, baseline to Week 104, Week 16 to Week 52, and Week 16 to Week 104

CRT were evaluated using spectral domain Optical coherence tomograph (OCT).

From baseline to Week 52

Group	Value	95% CI
Early-start T&E Arm	-164.9	± 117.3
Late-start T&E Arm	-167.1	± 117.1

From baseline to Week 104

Group	Value	95% CI
Early-start T&E Arm	-161.6	± 135.6
Late-start T&E Arm	-158.6	± 125.1

Week 16

Group	Value	95% CI
Early-start T&E Arm	321.4	± 93.4
Late-start T&E Arm	322.5	± 104.0

From Week 16 to Week 52

Group	Value	95% CI
Early-start T&E Arm	-28.5	± 56.3
Late-start T&E Arm	-28.7	± 54.0

From Week 16 to Week 104

Group	Value	95% CI
Early-start T&E Arm	-25.1	± 68.9
Late-start T&E Arm	-20.2	± 70.0

Number of Study Drug Injections From Baseline to Week 52 and Baseline to Week 104 Secondary · At Week 52 and Week 104

Week 52

Group	Value	95% CI
Early-start T&E Arm	7.1	± 0.8
Late-start T&E Arm	8.0	± 0.2

Week 104

Group	Value	95% CI
Early-start T&E Arm	12.0	± 2.3
Late-start T&E Arm	13.0	± 1.8

Duration of Last Treatment Interval Secondary · 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

Group	Value	95% CI
Early-start T&E Arm	11.5	± 3.7
Late-start T&E Arm	11.4	± 3.7

Percentage of Participants Requiring Retreatment at 8 Weeks, 10 Weeks, 12 Weeks, 14 Weeks, and 16 Weeks as the Last Treatment Interval Secondary · at 8 weeks, 10 weeks, 12 weeks, 14 weeks, and 16 weeks

<8 weeks

Group	Value	95% CI
Early-start T&E Arm	5.7
Late-start T&E Arm	7.7

8 weeks

Group	Value	95% CI
Early-start T&E Arm	27.4
Late-start T&E Arm	29.8

10 weeks

Group	Value	95% CI
Early-start T&E Arm	19.8
Late-start T&E Arm	10.6

12 weeks

Group	Value	95% CI
Early-start T&E Arm	8.5
Late-start T&E Arm	13.5

14 weeks

Group	Value	95% CI
Early-start T&E Arm	8.5
Late-start T&E Arm	11.5

16 weeks

Group	Value	95% CI
Early-start T&E Arm	25.5
Late-start T&E Arm	25.0

>16 weeks

Group	Value	95% CI
Early-start T&E Arm	4.7
Late-start T&E Arm	1.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment-emergent adverse events (TEAEs) were AEs that started after the first application of aflibercept up to 30 days after last study drug Injection in the study. TEAEs were collected from Week 0 till End of study/Week 104 or early termination.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Early-start T&E Arm

Serious: 29/135 (21%)

Deaths: 3/135

Late-start T&E Arm

Serious: 35/136 (26%)

Deaths: 4/136

Treated, But Not Randomized

Serious: 3/16 (19%)

Deaths: 0/16

Serious adverse events (96 terms)

Reaction	System	Early-start T&E Arm	Late-start T&E Arm	Treated, But Not Randomized
Pneumonia	Infections and infestations	—	—	—
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—
Visual acuity reduced	Eye disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Inguinal hernia	Gastrointestinal disorders	—	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—	—
Influenza	Infections and infestations	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Acute myocardial infarction	Cardiac disorders	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—
Atrial flutter	Cardiac disorders	—	—	—
Atrioventricular block	Cardiac disorders	—	—	—
Atrioventricular block second degree	Cardiac disorders	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—
Cor pulmonale acute	Cardiac disorders	—	—	—
Coronary artery stenosis	Cardiac disorders	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—
Pericardial haemorrhage	Cardiac disorders	—	—	—
Ventricular tachycardia	Cardiac disorders	—	—	—
Congestive cardiomyopathy	Cardiac disorders	—	—	—
Cardiac valve disease	Cardiac disorders	—	—	—
Eye inflammation	Eye disorders	—	—	—
Retinal artery embolism	Eye disorders	—	—	—

Other adverse events (28 terms — click to expand)

Reaction	System	Early-start T&E Arm	Late-start T&E Arm	Treated, But Not Randomized
Visual acuity reduced	Eye disorders	—	—	—
Conjunctival haemorrhage	Eye disorders	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—
Neovascular age-related macular degeneration	Eye disorders	—	—	—
Hypertension	Vascular disorders	—	—	—
Influenza	Infections and infestations	—	—	—
Blepharitis	Eye disorders	—	—	—
Dry eye	Eye disorders	—	—	—
Punctate keratitis	Eye disorders	—	—	—
Cataract	Eye disorders	—	—	—
Visual impairment	Eye disorders	—	—	—
Vitreous floaters	Eye disorders	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Cataract nuclear	Eye disorders	—	—	—
Choroidal neovascularisation	Eye disorders	—	—	—
Macular degeneration	Eye disorders	—	—	—
Retinal haemorrhage	Eye disorders	—	—	—
Macular fibrosis	Eye disorders	—	—	—
Corneal erosion	Eye disorders	—	—	—
Retinal pigment epithelial tear	Eye disorders	—	—	—
Gastroenteritis	Infections and infestations	—	—	—
Vitreous adhesions	Eye disorders	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—
Erythema of eyelid	Eye disorders	—	—	—
Swelling of eyelid	Eye disorders	—	—	—
Foreign body in eye	Injury, poisoning and procedural complications	—	—	—
Post procedural swelling	Injury, poisoning and procedural complications	—	—	—
Dyslipidaemia	Metabolism and nutrition disorders	—	—	—

Most-reported serious reactions: Pneumonia, Infective exacerbation of chronic obstructive airways disease, Cardiac failure congestive, Visual acuity reduced, Abdominal pain, Inguinal hernia, Cholecystitis acute, Influenza.

Data from ClinicalTrials.gov NCT02581891 adverse events section.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

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.
Mitchell P, Holz FG, Hykin P, Midena E, et al · · 2021 · cited 77× · PMID 33782365 · DOI 10.1097/iae.0000000000003128
Use of Correct and Incorrect Methods of Accounting for Age in Studies of Epigenetic Accelerated Aging: Implications and Recommendations for Best Practices.
Krieger N, Chen JT, Testa C, Diez Roux A, et al · · 2023 · cited 45× · PMID 36721372 · DOI 10.1093/aje/kwad025
Treat-and-Extend Regimens for the Management of Neovascular Age-related Macular Degeneration and Polypoidal Choroidal Vasculopathy: Consensus and Recommendations From the Asia-Pacific Vitreo-retina Society.
Chaikitmongkol V, Sagong M, Lai TYY, Tan GSW, et al · · 2021 · cited 42× · PMID 34839342 · DOI 10.1097/apo.0000000000000445
Association Between Visual Acuity and Fluid Compartments with Treat-and-Extend Intravitreal Aflibercept in Neovascular Age-Related Macular Degeneration: An ARIES Post Hoc Analysis.
Chaudhary V, Holz FG, Wolf S, Midena E, et al · · 2022 · cited 11× · PMID 35303285 · DOI 10.1007/s40123-022-00491-1
Patients with Neovascular Age-Related Macular Degeneration Requiring Intensive Intravitreal Aflibercept Treatment: An ARIES Post Hoc Analysis.
Wolf S, Holz FG, Midena E, Souied EH, et al · · 2022 · cited 2× · PMID 35821380 · DOI 10.1007/s40123-022-00541-8
Aflibercept 8 mg treat-and-extend pathway for the treatment of neovascular age-related macular degeneration: guidance from a UK expert panel.
Gale R, Awad MH, Bailey C, Cackett P, et al · · 2026 · cited 1× · PMID 41545709 · DOI 10.1038/s41433-025-04180-8
A post-hoc analysis of intravitreal aflibercept-treated nAMD patients from ARIES & ALTAIR: predicting treatment intervals and frequency for aflibercept treat-and-extend therapy regimen using machine learning.
Gutfleisch M, Heimes-Bussmann B, Aydin S, Petrovic R, et al · · 2025 · PMID 40210713 · DOI 10.1007/s00417-025-06812-x
Hypothetical Switch of Anti-Vascular Endothelial Growth Factor in Neovascular Age-Related Macular Degeneration: An ARIES Post Hoc Analysis.
Tuerksever C, Somfai GM, Oesch S, Machewitz T, et al · · 2022 · PMID 35066801 · DOI 10.1007/s40123-021-00448-w

Verify or expand the search:

Other recruiting trials for Macular Degeneration

Currently open trials in the same condition.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02581891 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 8 November 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02581891.

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