Trial · NCT02540954

Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

NCT02540954, Phase 3, Completed, Bayer; results first posted 2021-04-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD). Trials, record NCT02540954. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02540954

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Two Different Aflibercept Regimens in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
NCT number: NCT02540954
Status: Completed
Phases: Phase 3
Enrollment: 336 participants, actual
Lead sponsor: Bayer
Conditions: Macular Degeneration
Interventions: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)
First posted: 2015-09-04
Last updated: 2021-06-11
Other registries' IDs: eudract:2013-000120-33
Results first posted: 2021-04-08

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye	From baseline to Week 52	Visual function was assessed with the procedure from the ETDRS adapted for the Age Related Eye Disease Study using charts with 70 letters at a starting distance of 4 meters. Charts are organized in 14 lines of decreasing size with 5 letters each. Participants reading up to 19 letters at 4 meters were tested at 1 meter to read the first 6 lines. The score equals the sum of letters read at 1 meter and 4 meters. If more than 19 letters are read at 4 meters the score equals the number of letters read plus 30. The score range is 0 to 100, and a higher score represents better visual function.
Secondary	Percentage of Participants Maintaining Vision in the Study Eye	At week 52	A participant was classified as maintaining vision if the participant had lost fewer than 15 letters in the ETDRS letter score compared to baseline.
Secondary	Percentage of Participants Who Gained From Baseline 5 or More Letters in the Study Eye	At week 52
Secondary	Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye	From baseline to week 52	Retinal characteristic was evaluated using Optical coherence tomography (OCT).
Secondary	Mean Change From Baseline in Choroidal Neovascularization (CNV) Area in the Study Eye	From baseline to week 52	Choroidal neovascularization measured by optical coherence tomography (OCT).
Secondary	Percentage of Participants Who Lost From Baseline 30 or More Letters in the Study Eye	At week 52
Secondary	Mean Change From Baseline in Total Score for National Eye Institute 25-Item Visual Function (NEI VFQ-25) Questionnaire	From baseline to week 52	National Eye Institute 25-Item Visual Function Questionnaire (NEI VFQ-25) total score ranges from 0 to 100, where 100 represents the best possible score and 0 represents the worst.
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAE)	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

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye	From baseline to Week 52	The outcome measure was analyzed based on full analysis set (FAS). The FAS included all randomized participants who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.	Letters read correctly	MEAN
SECONDARY	Percentage of Participants Maintaining Vision in the Study Eye	At week 52	The outcome measure was analyzed based on full analysis set (FAS). The FAS included all randomized participants who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.	Percentage of participants	NUMBER
SECONDARY	Percentage of Participants Who Gained From Baseline 5 or More Letters in the Study Eye	At week 52	The outcome measure was analyzed based on full analysis set (FAS). The FAS included all randomized participants who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.	Percentage of participants	NUMBER
SECONDARY	Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye	From baseline to week 52	The outcome measure was analyzed based on full analysis set (FAS) with number of participants evaluable for this specific end point.	μm	MEAN
SECONDARY	Mean Change From Baseline in Choroidal Neovascularization (CNV) Area in the Study Eye	From baseline to week 52	The outcome measure was analyzed based on full analysis set (FAS) with number of participants evaluable for this specific end point.	mm*2	MEAN
SECONDARY	Percentage of Participants Who Lost From Baseline 30 or More Letters in the Study Eye	At week 52	The outcome measure was analyzed based on full analysis set (FAS). The FAS included all randomized participants who received any study drug and had a baseline BCVA assessment and at least one post-baseline BCVA assessment.	Percentage of participants	NUMBER
SECONDARY	Mean Change From Baseline in Total Score for National Eye Institute 25-Item Visual Function (NEI VFQ-25) Questionnaire	From baseline to week 52	The outcome measure was analyzed based on full analysis set (FAS) with number of participants evaluable for this specific end point.	Score on a scale	MEAN
SECONDARY	Number of Participants With Treatment-emergent Adverse Events (TEAE)	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	Number of participants with TEAE was analyzed based on safety analysis set (SAF) with number of participants evaluable.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye	Aflibercept Extended Dosing	-0.3	Standard Deviation 7.5	Letters read correctly
Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye	Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)	-0.5	Standard Deviation 8.4	Letters read correctly
Percentage of Participants Maintaining Vision in the Study Eye	Aflibercept Extended Dosing	95.2		Percentage of participants
Percentage of Participants Maintaining Vision in the Study Eye	Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)	94.0		Percentage of participants
Percentage of Participants Who Gained From Baseline 5 or More Letters in the Study Eye	Aflibercept Extended Dosing	24.2		Percentage of participants
Percentage of Participants Who Gained From Baseline 5 or More Letters in the Study Eye	Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)	21.0		Percentage of participants
Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye	Aflibercept Extended Dosing	-24.4	Standard Deviation 55.2	μm
Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye	Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)	-33.4	Standard Deviation 47.1	μm
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area in the Study Eye	Aflibercept Extended Dosing	0.274	Standard Deviation 2.723	mm*2
Mean Change From Baseline in Choroidal Neovascularization (CNV) Area in the Study Eye	Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)	0.204	Standard Deviation 2.813	mm*2

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow10

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Aflibercept Extended Dosing	168
Overall Study	STARTED	Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)	168
Overall Study	Treated	Aflibercept Extended Dosing	167
Overall Study	Treated	Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)	168
Overall Study	Post-baseline BCVA Assessment	Aflibercept Extended Dosing	165
Overall Study	Post-baseline BCVA Assessment	Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)	167
Overall Study	COMPLETED	Aflibercept Extended Dosing	149
Overall Study	COMPLETED	Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)	154
Overall Study	NOT COMPLETED	Aflibercept Extended Dosing	19
Overall Study	NOT COMPLETED	Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)	14

Source ClinicalTrials.gov

Adverse events132

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Cataract	Eye disorders	Aflibercept Extended Dosing	17	167	22
other	Cataract	Eye disorders	Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)	19	168	27
other	Visual acuity reduced	Eye disorders	Aflibercept Extended Dosing	14	167	18
other	Visual acuity reduced	Eye disorders	Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)	4	168	6
other	Choroidal neovascularisation	Eye disorders	Aflibercept Extended Dosing	9	167	10
other	Choroidal neovascularisation	Eye disorders	Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)	9	168	9
other	Subretinal fluid	Eye disorders	Aflibercept Extended Dosing	14	167	17
other	Subretinal fluid	Eye disorders	Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)	14	168	16
other	Neovascular age-related macular degeneration	Eye disorders	Aflibercept Extended Dosing	8	167	9
other	Neovascular age-related macular degeneration	Eye disorders	Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)	10	168	12

1 to 10 of 132Source ClinicalTrials.gov

See all 132 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Aflibercept Extended Dosing	0	167
Total, all-cause mortality	Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)	3	168
Total, other adverse events	Aflibercept Extended Dosing	60	167
Total, other adverse events	Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)	70	168
Total, serious adverse events	Aflibercept Extended Dosing	26	167
Total, serious adverse events	Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks)	23	168

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38183525	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Aflibercept Extended Dosing vs Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks): deaths from any cause	Trial comparisons
Aflibercept Extended Dosing vs Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks): serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02540954

GET https://conductscience.org/api/trials/v1/NCT02540954/events?page=2

API reference For AI assistants