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Trial · NCT01940900

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

NCT01940900, Phase 3, Terminated, Ophthotech Corporation; results first posted 2018-08-15

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 Lucentis® Compared to Lucentis® Monotherapy. Trials, record NCT01940900. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01940900

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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 Lucentis® Compared to Lucentis® Monotherapy
NCT number
NCT01940900
Status
Terminated
Phases
Phase 3
Enrollment
627 participants, actual
Lead sponsor
Ophthotech Corporation
Conditions
Age-Related Macular Degeneration
Interventions
E10030, ranibizumab, E10030 sham intravitreal injection
First posted
2013-09-12
Last updated
2024-10-30
Results first posted
2018-08-15

Source ClinicalTrials.gov

Registered outcomes1

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

ListOutcomeTime frameDescription
PrimaryMean Change in Visual Acuity From Baseline to 12 Months12 Months
The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline to 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 From Baseline to 12 Months12 MonthsMean change in visual acuity (ETDRS letter) from Baseline to Month 12lettersMEAN

Results by group2

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

OutcomeGroupCategoryValueSpreadUnits
Mean Change in Visual Acuity From Baseline to 12 MonthsE10030 + Ranibizumab9.91Standard Error 0.88letters
Mean Change in Visual Acuity From Baseline to 12 MonthsSham + Ranibizumab10.36Standard Error 0.87letters

Participant flow6

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDE10030 + Ranibizumab311
Overall StudySTARTEDSham + Ranibizumab315
Overall StudyCOMPLETEDE10030 + Ranibizumab282
Overall StudyCOMPLETEDSham + Ranibizumab284
Overall StudyNOT COMPLETEDE10030 + Ranibizumab29
Overall StudyNOT COMPLETEDSham + Ranibizumab31

Adverse events224

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

TypeEventOrgan systemGroupAffectedAt riskEvents
otherConjunctival haemorrhageEye disordersE10030 + Ranibizumab74312166
otherConjunctival haemorrhageEye disordersSham + Ranibizumab50314136
otherPunctate keratitisEye disordersE10030 + Ranibizumab3531293
otherPunctate keratitisEye disordersSham + Ranibizumab4031497
otherConjuctival hyperaemiaEye disordersE10030 + Ranibizumab2431248
otherConjuctival hyperaemiaEye disordersSham + Ranibizumab2431453
otherEye painEye disordersE10030 + Ranibizumab2231251
otherEye painEye disordersSham + Ranibizumab2131435
otherVitreous floatersEye disordersE10030 + Ranibizumab2231228
otherVitreous floatersEye disordersSham + Ranibizumab1231413

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityE10030 + Ranibizumab4312
Total, all-cause mortalitySham + Ranibizumab4314
Total, other adverse eventsE10030 + Ranibizumab161312
Total, other adverse eventsSham + Ranibizumab136314
Total, serious adverse eventsE10030 + Ranibizumab56312
Total, serious adverse eventsSham + Ranibizumab49314

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 + Ranibizumab vs Sham + Ranibizumab: deaths from any causeTrial comparisons
E10030 + Ranibizumab vs Sham + Ranibizumab: 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/NCT01940900

GET https://conductscience.org/api/trials/v1/NCT01940900/events?page=2