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Trial · NCT01940887

A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy

NCT01940887, Phase 3, Terminated, Ophthotech Corporation; results first posted 2020-09-30

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy. Trials, record NCT01940887. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01940887

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Trial

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

Title
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy
NCT number
NCT01940887
Status
Terminated
Phases
Phase 3
Enrollment
645 participants, actual
Lead sponsor
Ophthotech Corporation
Conditions
Age-Related Macular Degeneration
Interventions
E10030, bevacizumab or aflibercept, E10030 sham injection
First posted
2013-09-12
Last updated
2024-10-31
Results first posted
2020-09-30

Source ClinicalTrials.gov

Registered outcomes1

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

ListOutcomeTime frameDescription
PrimaryMean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit)12 months
The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) measured at baseline and at the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.

Outcomes1

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYMean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit)12 months
As pre-specified in the SAP and per the study design, 2 treatment groups (E10030 +Eylea/Avastin vs. Sham + Eylea/Avastin) will be compared. All 642 subjects who received at least one dose of the study drug, irrespective of the dose received, were included in the analysis.
lettersMEAN

Results by group2

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

OutcomeGroupCategoryValueSpreadUnits
Mean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit)E10030 + Bevacizumab or Aflibercept9.42Standard Error 0.85letters
Mean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit)Sham + Bevacizumab or Aflibercept9.04Standard Error 0.85letters

Participant flow12

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

PeriodMilestoneGroupParticipantsUnits counted
Year 1STARTEDE10030 + Bevacizumab or Aflibercept322
Year 1STARTEDSham + Bevacizumab or Aflibercept320
Year 1COMPLETEDE10030 + Bevacizumab or Aflibercept283
Year 1COMPLETEDSham + Bevacizumab or Aflibercept297
Year 1NOT COMPLETEDE10030 + Bevacizumab or Aflibercept39
Year 1NOT COMPLETEDSham + Bevacizumab or Aflibercept23
Year 2STARTEDE10030 + Bevacizumab or Aflibercept283
Year 2STARTEDSham + Bevacizumab or Aflibercept297
Year 2COMPLETEDE10030 + Bevacizumab or Aflibercept66
Year 2COMPLETEDSham + Bevacizumab or Aflibercept75

Adverse events202

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

TypeEventOrgan systemGroupAffectedAt riskEvents
otherIntraocular pressure increasedInvestigationsE10030 + Bevacizumab or Aflibercept2232246
otherIntraocular pressure increasedInvestigationsSham + Bevacizumab or Aflibercept2032035
otherConjunctival haemorrhageEye disordersE10030 + Bevacizumab or Aflibercept3932285
otherConjunctival haemorrhageEye disordersSham + Bevacizumab or Aflibercept3132048
otherPunctate keratitisEye disordersE10030 + Bevacizumab or Aflibercept2132234
otherPunctate keratitisEye disordersSham + Bevacizumab or Aflibercept1432039
otherEye painEye disordersE10030 + Bevacizumab or Aflibercept1832226
otherEye painEye disordersSham + Bevacizumab or Aflibercept2132035
otherVitreous detachmentEye disordersE10030 + Bevacizumab or Aflibercept2032221
otherVitreous detachmentEye disordersSham + Bevacizumab or Aflibercept1932023

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityE10030 + Bevacizumab or Aflibercept7322
Total, all-cause mortalitySham + Bevacizumab or Aflibercept6320
Total, other adverse eventsE10030 + Bevacizumab or Aflibercept105322
Total, other adverse eventsSham + Bevacizumab or Aflibercept107320
Total, serious adverse eventsE10030 + Bevacizumab or Aflibercept58322
Total, serious adverse eventsSham + Bevacizumab or Aflibercept32320

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
30957581DERIVED

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.

ComparisonSource
E10030 + Bevacizumab or Aflibercept vs Sham + Bevacizumab or Aflibercept: deaths from any causeTrial comparisons
E10030 + Bevacizumab or Aflibercept vs Sham + Bevacizumab or Aflibercept: serious adverse eventsTrial 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/NCT01940887

GET https://conductscience.org/api/trials/v1/NCT01940887/events?page=2