Trial · NCT02800642

Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO

NCT02800642, Phase 4, Completed, Bayer; results first posted 2020-07-08

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO. Trials, record NCT02800642. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02800642

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Trial

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

Title: Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO
NCT number: NCT02800642
Status: Completed
Phases: Phase 4
Enrollment: 162 participants, actual
Lead sponsor: Bayer
Conditions: Central Retinal Vein Occlusion
Interventions: Aflibercept (Eylea, BAY86-5321)
First posted: 2016-06-15
Last updated: 2020-07-08
Other registries' IDs: eudract:2014-003193-17
Results first posted: 2020-07-08

Source ClinicalTrials.gov

Registered outcomes10

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

List	Outcome	Time frame	Description
Primary	The Proportion of Participants Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline	Baseline, Week 24 and Week 76	Participants who completed the study with a gain of ≥ 15 letters or dropped the study after Week 24 and having a permanent resolution of macular edema and a gain of ≥ 15 letters from baseline with regard to the latest BCVA assessment. The ETDRS chart includes 70 letters in total, more letters read correctly represents a better visual acuity.
Primary	The Proportion of Participants With a Mean Treatment Interval Between Injections of ≥ 8 Weeks	From the last actual visit of the initiation phase to Week 76	Participants who completed the study with a mean treatment interval between injections of ≥ 8 weeks or dropped out of the study after Week 24 and having a permanent resolution of macular edema
Secondary	The Mean Treatment Interval Between Injections	From baseline to Week 76
Secondary	The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline	Baseline and Week 24, 52, and 76	The ETDRS chart includes 70 letters in total and the letter score ranges from 0 to 100. More letters read correctly results in a higher letter score, which represents better visual acuity
Secondary	The Change in Central Retinal Thickness (CRT) From Baseline	Baseline and Week 24, 52 and 76	CRT was measured in the study eye by spectral domain optical coherence tomography (SD-OCT).
Secondary	The Number of Injections Per Participant	From baseline to Week 76
Secondary	The Proportion of Participants Who Gain ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline	Baseline and Week 24, Week 52	The ETDRS chart includes 70 letters in total. More letters read correctly represents a better visual acuity
Secondary	The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline	Baseline and Week 24, 52 and 76	The change in retinal non-perfusion status by fundus angiography (FA)/fundus photography (FP)-confirmed ischemic disc area. The status was categorized into: no non-perfusion, \<10 ischemic disc area, \>=10 ischemic disc area and missing status
Secondary	The Proportion of Participants With Absence of Subretinal Fluid	Baseline, week 24, week 52 and week 76
Secondary	Incidence and Severity of Ocular Treatment-emergent Adverse Events	Up to 30 days after week 76

Source ClinicalTrials.gov

Outcomes10

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

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	The Mean Treatment Interval Between Injections	From baseline to Week 76	Participants in full analysis set (received any study drug, had a baseline BCVA assessment and at least one post-baseline BCVA assessment) that completed study	weeks	MEAN
PRIMARY	The Proportion of Participants Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline	Baseline, Week 24 and Week 76	Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment. Last observation carried forward (LOCF) imputation method.	percent	NUMBER
PRIMARY	The Proportion of Participants With a Mean Treatment Interval Between Injections of ≥ 8 Weeks	From the last actual visit of the initiation phase to Week 76	Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment	percent	NUMBER
SECONDARY	The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline	Baseline and Week 24, 52, and 76	Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment	scores	MEAN
SECONDARY	The Change in Central Retinal Thickness (CRT) From Baseline	Baseline and Week 24, 52 and 76	Included all participants who received any study drug, had a baseline CRT assessment, and had post-baseline CRT assessment at Week 24, 52 and 76	micrometer	MEAN
SECONDARY	The Number of Injections Per Participant	From baseline to Week 76	Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment	injections	MEAN
SECONDARY	The Proportion of Participants Who Gain ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline	Baseline and Week 24, Week 52	Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment	percent	NUMBER
SECONDARY	The Proportion of Participants With Change in Retinal Non-perfusion (FA/FP) Status From Baseline	Baseline and Week 24, 52 and 76	Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment	percent	NUMBER
SECONDARY	The Proportion of Participants With Absence of Subretinal Fluid	Baseline, week 24, week 52 and week 76	Full analysis set: included all participants who received any study drug, had a baseline BCVA assessment, and had at least one post-baseline BCVA assessment.	percent	NUMBER
SECONDARY	Incidence and Severity of Ocular Treatment-emergent Adverse Events	Up to 30 days after week 76	Safety analysis set: included all participants who received any study drug	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group66

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

Outcome	Group	Category	Value	Spread	Units
The Mean Treatment Interval Between Injections	Intravitreal (IVT) Aflibercept		6.37	Standard Deviation 1.150	weeks
The Proportion of Participants Who Gained ≥ 15 Letters in Best Corrected Visual Acuity (BCVA) on the Early Treatment Diabetic Retinopathy Score (ETDRS) Chart Compared to Baseline	Intravitreal (IVT) Aflibercept		65.6	95% Confidence Interval 57.7	percent
The Proportion of Participants With a Mean Treatment Interval Between Injections of ≥ 8 Weeks	Intravitreal (IVT) Aflibercept		45.0	95% Confidence Interval 37.1	percent
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline	Intravitreal (IVT) Aflibercept	Absolute BCVA letter score at baseline	51.9	Standard Deviation 16.8	scores
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline	Intravitreal (IVT) Aflibercept	Absolute BCVA letter score at Week 24	72.4	Standard Deviation 16.6	scores
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline	Intravitreal (IVT) Aflibercept	Absolute BCVA letter score at Week 52	71.8	Standard Deviation 18.1	scores
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline	Intravitreal (IVT) Aflibercept	Absolute BCVA letter score at Week 76	72.3	Standard Deviation 18.5	scores
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline	Intravitreal (IVT) Aflibercept	Change from baseline at Week 24	20.4	Standard Deviation 17.0	scores
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline	Intravitreal (IVT) Aflibercept	Change from baseline at Week 52	19.9	Standard Deviation 19.1	scores
The Change in Best Corrected Visual Acuity (BCVA) as Measured by the Early Treatment Diabetic Retinopathy Letter Score (ETDRS) From Baseline	Intravitreal (IVT) Aflibercept	Change from baseline at Week 76	20.3	Standard Deviation 19.5	scores

1 to 10 of 66Source ClinicalTrials.gov

See all 66 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Intravitreal (IVT) Aflibercept	162
Overall Study	COMPLETED	Intravitreal (IVT) Aflibercept	137
Overall Study	NOT COMPLETED	Intravitreal (IVT) Aflibercept	25

Source ClinicalTrials.gov

Adverse events51

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	Macular oedema	Eye disorders	Intravitreal (IVT) Aflibercept	12	162	13
other	Conjunctival haemorrhage	Eye disorders	Intravitreal (IVT) Aflibercept	18	162	23
other	Retinal ischaemia	Eye disorders	Intravitreal (IVT) Aflibercept	13	162	16
other	Retinal haemorrhage	Eye disorders	Intravitreal (IVT) Aflibercept	14	162	14
other	Visual acuity reduced	Eye disorders	Intravitreal (IVT) Aflibercept	26	162	37
other	Vitreous detachment	Eye disorders	Intravitreal (IVT) Aflibercept	9	162	11
other	Foreign body sensation in eyes	Eye disorders	Intravitreal (IVT) Aflibercept	9	162	13
other	Nasopharyngitis	Infections and infestations	Intravitreal (IVT) Aflibercept	26	162	40
other	Intraocular pressure increased	Investigations	Intravitreal (IVT) Aflibercept	20	162	40
other	Hypertension	Vascular disorders	Intravitreal (IVT) Aflibercept	19	162	25

1 to 10 of 51Source ClinicalTrials.gov

See all 51 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Intravitreal (IVT) Aflibercept	4	162
Total, other adverse events	Intravitreal (IVT) Aflibercept	81	162
Total, serious adverse events	Intravitreal (IVT) Aflibercept	32	162

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33556381	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 comparisons0

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

None in this release.

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.

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Read this trial from software.

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

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