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
Cite this record
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
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 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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean 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. |
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 (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. | 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 (Measured at Baseline and at the Month 12 Visit) | E10030 + Bevacizumab or Aflibercept | 9.42 | Standard Error 0.85 | letters | |
| Mean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit) | Sham + Bevacizumab or Aflibercept | 9.04 | Standard Error 0.85 | letters |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Year 1 | STARTED | E10030 + Bevacizumab or Aflibercept | 322 | |
| Year 1 | STARTED | Sham + Bevacizumab or Aflibercept | 320 | |
| Year 1 | COMPLETED | E10030 + Bevacizumab or Aflibercept | 283 | |
| Year 1 | COMPLETED | Sham + Bevacizumab or Aflibercept | 297 | |
| Year 1 | NOT COMPLETED | E10030 + Bevacizumab or Aflibercept | 39 | |
| Year 1 | NOT COMPLETED | Sham + Bevacizumab or Aflibercept | 23 | |
| Year 2 | STARTED | E10030 + Bevacizumab or Aflibercept | 283 | |
| Year 2 | STARTED | Sham + Bevacizumab or Aflibercept | 297 | |
| Year 2 | COMPLETED | E10030 + Bevacizumab or Aflibercept | 66 | |
| Year 2 | COMPLETED | Sham + Bevacizumab or Aflibercept | 75 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events202
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 + Bevacizumab or Aflibercept | 22 | 322 | 46 |
| other | Intraocular pressure increased | Investigations | Sham + Bevacizumab or Aflibercept | 20 | 320 | 35 |
| other | Conjunctival haemorrhage | Eye disorders | E10030 + Bevacizumab or Aflibercept | 39 | 322 | 85 |
| other | Conjunctival haemorrhage | Eye disorders | Sham + Bevacizumab or Aflibercept | 31 | 320 | 48 |
| other | Punctate keratitis | Eye disorders | E10030 + Bevacizumab or Aflibercept | 21 | 322 | 34 |
| other | Punctate keratitis | Eye disorders | Sham + Bevacizumab or Aflibercept | 14 | 320 | 39 |
| other | Eye pain | Eye disorders | E10030 + Bevacizumab or Aflibercept | 18 | 322 | 26 |
| other | Eye pain | Eye disorders | Sham + Bevacizumab or Aflibercept | 21 | 320 | 35 |
| other | Vitreous detachment | Eye disorders | E10030 + Bevacizumab or Aflibercept | 20 | 322 | 21 |
| other | Vitreous detachment | Eye disorders | Sham + Bevacizumab or Aflibercept | 19 | 320 | 23 |
1 to 10 of 202Source ClinicalTrials.gov
See all 202 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | E10030 + Bevacizumab or Aflibercept | 7 | 322 |
| Total, all-cause mortality | Sham + Bevacizumab or Aflibercept | 6 | 320 |
| Total, other adverse events | E10030 + Bevacizumab or Aflibercept | 105 | 322 |
| Total, other adverse events | Sham + Bevacizumab or Aflibercept | 107 | 320 |
| Total, serious adverse events | E10030 + Bevacizumab or Aflibercept | 58 | 322 |
| Total, serious adverse events | Sham + Bevacizumab or Aflibercept | 32 | 320 |
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 + Bevacizumab or Aflibercept vs Sham + Bevacizumab or Aflibercept: deaths from any cause | Trial comparisons |
| E10030 + Bevacizumab or Aflibercept vs Sham + Bevacizumab or Aflibercept: 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.
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