Trial · NCT01944839

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

NCT01944839, Phase 3, Terminated, Ophthotech Corporation; results first posted 2018-08-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy. Trials, record NCT01944839. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01944839

On this page

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: NCT01944839
Status: Terminated
Phases: Phase 3
Enrollment: 619 participants, actual
Lead sponsor: Ophthotech Corporation
Conditions: Age-Related Macular Degeneration
Interventions: E10030, ranibizumab, E10030 sham intravitreal injection
First posted: 2013-09-18
Last updated: 2024-10-30
Results first posted: 2018-08-10

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Mean Change in Visual Acuity From Baseline to 12 Months	12 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.

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean Change in Visual Acuity From Baseline to 12 Months	12 Months		letters	MEAN

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Mean Change in Visual Acuity From Baseline to 12 Months	E10030 + Ranibizumab		10.74	Standard Error 0.86	letters
Mean Change in Visual Acuity From Baseline to 12 Months	Sham + Ranibizumab		9.82	Standard Error 0.86	letters

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	E10030 + Ranibizumab	309
Overall Study	STARTED	Sham + Ranibizumab	310
Overall Study	COMPLETED	E10030 + Ranibizumab	287
Overall Study	COMPLETED	Sham + Ranibizumab	282
Overall Study	NOT COMPLETED	E10030 + Ranibizumab	22
Overall Study	NOT COMPLETED	Sham + Ranibizumab	28

Source ClinicalTrials.gov

Adverse events206

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	Intraocular pressure increased	Investigations	E10030 + Ranibizumab	43	310	157
other	Intraocular pressure increased	Investigations	Sham + Ranibizumab	30	309	78
other	Conjunctival haemorrhage	Eye disorders	E10030 + Ranibizumab	60	310	197
other	Conjunctival haemorrhage	Eye disorders	Sham + Ranibizumab	56	309	177
other	Eye pain	Eye disorders	E10030 + Ranibizumab	23	310	29
other	Eye pain	Eye disorders	Sham + Ranibizumab	26	309	47
other	Punctate keratitis	Eye disorders	E10030 + Ranibizumab	15	310	22
other	Punctate keratitis	Eye disorders	Sham + Ranibizumab	18	309	30
other	Nasopharyngitis	Infections and infestations	E10030 + Ranibizumab	19	310	20
other	Nasopharyngitis	Infections and infestations	Sham + Ranibizumab	6	309	6

1 to 10 of 206Source ClinicalTrials.gov

See all 206 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	E10030 + Ranibizumab	6	310
Total, all-cause mortality	Sham + Ranibizumab	2	309
Total, other adverse events	E10030 + Ranibizumab	123	310
Total, other adverse events	Sham + Ranibizumab	114	309
Total, serious adverse events	E10030 + Ranibizumab	48	310
Total, serious adverse events	Sham + Ranibizumab	36	309

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
30957581	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
E10030 + Ranibizumab vs Sham + Ranibizumab: deaths from any cause	Trial comparisons
E10030 + Ranibizumab vs Sham + Ranibizumab: 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/NCT01944839

GET https://conductscience.org/api/trials/v1/NCT01944839/events?page=2

API reference For AI assistants