Trial · NCT02859441
A Phase I/II Trial for Intravitreous Treatment of Severe Ocular Von Hippel-Lindau Disease Using a Combination of the PDGF Antagonist E10030 and the VEGF Antagonist Ranibizumab
NCT02859441, Phase 1, Phase 2, Completed, National Eye Institute (NEI); results first posted 2020-07-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase I/II Trial for Intravitreous Treatment of Severe Ocular Von Hippel-Lindau Disease Using a Combination of the PDGF Antagonist E10030 and the VEGF Antagonist Ranibizumab. Trials, record NCT02859441. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02859441
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I/II Trial for Intravitreous Treatment of Severe Ocular Von Hippel-Lindau Disease Using a Combination of the PDGF Antagonist E10030 and the VEGF Antagonist Ranibizumab
- NCT number
- NCT02859441
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- National Eye Institute (NEI)
- Conditions
- Von Hippel-Lindau Syndrome
- Interventions
- Ranibizumab, E10030
- First posted
- 2016-08-09
- Last updated
- 2021-11-01
- Results first posted
- 2020-07-14
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tabulation of Adverse Events | From Baseline to Week 52 | The total number of adverse events through Week 52. |
| Secondary | Tabulation of Adverse Events | From Baseline to Week 104 | The total number of adverse events, excluding natural progression of disease events, through Week 104. |
| Secondary | The Proportion of Participants Experiencing Reduction in Size of at Least One Retinal Capillary Hemangioma (RCH), in the Absence of Other Ablative Treatment (Assessed by Fundus Photography and Fluorescein Angiography (FA)) | From Baseline to Week 52 | The proportion of participants experiencing a reduction in size of at least one RCH in the study eye, in the absence of other ablative treatment as assessed by fundus photography and fluorescein angiography (FA), between Baseline and Week 52. |
| Secondary | The Proportion of Participants Experiencing Reduction in Size of at Least One RCH, in the Absence of Other Ablative Treatment (Assessed by Fundus Photography and Fluorescein Angiography [FA]) | From Baseline to Week 104 | The proportion of participants experiencing a reduction in size of at least one RCH in the study eye, in the absence of other ablative treatment as assessed by fundus photography and fluorescein angiography (FA), between Baseline and Week 104. |
| Secondary | Proportion of Participants Undergoing Ablative Treatment of RCH or Ocular Surgery | From Baseline to Week 52 | The proportion of participants undergoing ablative treatment of RCH or ocular surgery in the study eye between Baseline and Week 52. |
| Secondary | Proportion of Participants Undergoing Ablative Treatment of RCH or Ocular Surgery | From Baseline to Week 104 | The proportion of participants undergoing ablative treatment of RCH or ocular surgery in the study eye between Baseline and Week 104. |
| Secondary | Proportion of Participants With Successful Ablative Treatment of RCH | From Baseline to Week 52 | The proportion of participants with successful ablative treatment of RCH in the study eye between Baseline and Week 52. |
| Secondary | Proportion of Participants With Successful Ablative Treatment of RCH | From Baseline to Week 104 | The proportion of participants with successful ablative treatment of RCH in the study eye between Baseline and Week 104. |
| Secondary | Mean Change in Visual Acuity | Baseline and Week 52 | Mean change in visual acuity in the study eye from Baseline as compared to Week 52 as measured using the Electronic Early Treatment of Diabetic Retinopathy Study (ETDRS) Visual Acuity (EVA) Testing protocol. Acuity is measured as letters read using an electronic ETDRS program. |
| Secondary | Mean Change in Visual Acuity | Baseline and Week 104 | Mean change in visual acuity in the study eye from Baseline as compared to Week 104 as measured using the Electronic Early Treatment of Diabetic Retinopathy Study (ETDRS) Visual Acuity (EVA) Testing protocol. Acuity is measured as letters read using an electronic ETDRS program. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tabulation of Adverse Events | From Baseline to Week 52 | adverse events | NUMBER | |
| SECONDARY | Tabulation of Adverse Events | From Baseline to Week 104 | adverse events | NUMBER | |
| SECONDARY | The Proportion of Participants Experiencing Reduction in Size of at Least One Retinal Capillary Hemangioma (RCH), in the Absence of Other Ablative Treatment (Assessed by Fundus Photography and Fluorescein Angiography (FA)) | From Baseline to Week 52 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Proportion of Participants Experiencing Reduction in Size of at Least One RCH, in the Absence of Other Ablative Treatment (Assessed by Fundus Photography and Fluorescein Angiography [FA]) | From Baseline to Week 104 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Participants Undergoing Ablative Treatment of RCH or Ocular Surgery | From Baseline to Week 52 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Participants Undergoing Ablative Treatment of RCH or Ocular Surgery | From Baseline to Week 104 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Proportion of Participants With Successful Ablative Treatment of RCH | From Baseline to Week 52 | No participants were analyzed for this outcome because none of the participants underwent ablative treatment of RCH. Therefore, no data was collected for this outcome. | ||
| SECONDARY | Proportion of Participants With Successful Ablative Treatment of RCH | From Baseline to Week 104 | No participants were analyzed for this outcome because none of the participants underwent ablative treatment of RCH. Therefore, no data was collected for this outcome. | ||
| SECONDARY | Mean Change in Visual Acuity | Baseline and Week 52 | Mean visual acuity values are presented for Baseline and Week 52 and the mean change at Week 52 from Baseline for the study eye. | Letters Read | MEAN |
| SECONDARY | Mean Change in Visual Acuity | Baseline and Week 104 | Mean visual acuity values are presented for Baseline and Week 104 and the mean change at Week 104 from Baseline for the study eye. | Letters Read | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tabulation of Adverse Events | E10030 and Ranibizumab | 13 | adverse events | ||
| Tabulation of Adverse Events | E10030 and Ranibizumab | 27 | adverse events | ||
The Proportion of Participants Experiencing Reduction in Size of at Least One Retinal Capillary Hemangioma (RCH), in the Absence of Other Ablative Treatment (Assessed by Fundus Photography and Fluorescein Angiography (FA)) | E10030 and Ranibizumab | 0 | Participants | ||
| The Proportion of Participants Experiencing Reduction in Size of at Least One RCH, in the Absence of Other Ablative Treatment (Assessed by Fundus Photography and Fluorescein Angiography [FA]) | E10030 and Ranibizumab | 0 | Participants | ||
| Proportion of Participants Undergoing Ablative Treatment of RCH or Ocular Surgery | E10030 and Ranibizumab | 0 | Participants | ||
| Proportion of Participants Undergoing Ablative Treatment of RCH or Ocular Surgery | E10030 and Ranibizumab | 0 | Participants | ||
| Mean Change in Visual Acuity | Visual Acuity at Baseline | 64.0 | Standard Deviation 26.3 | Letters Read | |
| Mean Change in Visual Acuity | Visual Acuity at Week 52 | 59.0 | Standard Deviation 21.3 | Letters Read | |
| Mean Change in Visual Acuity | Mean Change in Visual Acuity at Week 52 From Baseline | -5.0 | Standard Deviation 7.0 | Letters Read | |
| Mean Change in Visual Acuity | Visual Acuity at Baseline | 64.0 | Standard Deviation 26.3 | Letters Read |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | E10030 and Ranibizumab | 3 | |
| Overall Study | COMPLETED | E10030 and Ranibizumab | 3 | |
| Overall Study | NOT COMPLETED | E10030 and Ranibizumab | 0 |
Source ClinicalTrials.gov
Adverse events27
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 | Ocular Hypertension | Eye disorders | E10030 and Ranibizumab | 1 | 3 | 3 |
| other | Back Pain | Musculoskeletal and connective tissue disorders | E10030 and Ranibizumab | 1 | 3 | 1 |
| other | Hypoaesthesia | Nervous system disorders | E10030 and Ranibizumab | 1 | 3 | 1 |
| other | Infection | Infections and infestations | E10030 and Ranibizumab | 1 | 3 | 1 |
| other | Posterior Capsule Opacification | Eye disorders | E10030 and Ranibizumab | 1 | 3 | 1 |
| other | Visual Acuity Reduced | Eye disorders | E10030 and Ranibizumab | 2 | 3 | 3 |
| other | Vomiting | Gastrointestinal disorders | E10030 and Ranibizumab | 1 | 3 | 1 |
| other | Weight Decreased | Investigations | E10030 and Ranibizumab | 1 | 3 | 1 |
| other | Eye Pain | Eye disorders | E10030 and Ranibizumab | 1 | 3 | 1 |
| other | Limb Injury | Injury, poisoning and procedural complications | E10030 and Ranibizumab | 1 | 3 | 1 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | E10030 and Ranibizumab | 0 | 3 |
| Total, other adverse events | E10030 and Ranibizumab | 3 | 3 |
| Total, serious adverse events | E10030 and Ranibizumab | 2 | 3 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34549489 | RESULT |
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.
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/NCT02859441
GET https://conductscience.org/api/trials/v1/NCT02859441/results?page=2