Trial · NCT00673816
Sunitinib Malate to Treat Advanced Eye Disease in Patients With Von Hippel-Lindau Syndrome
NCT00673816, Phase 1, Phase 2, Terminated, National Eye Institute (NEI); results first posted 2011-12-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sunitinib Malate to Treat Advanced Eye Disease in Patients With Von Hippel-Lindau Syndrome. Trials, record NCT00673816. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00673816
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sunitinib Malate to Treat Advanced Eye Disease in Patients With Von Hippel-Lindau Syndrome
- NCT number
- NCT00673816
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- National Eye Institute (NEI)
- Conditions
- Von Hippel-Lindau Syndrome
- Interventions
- Sunitinib Malate
- First posted
- 2008-05-07
- Last updated
- 2024-01-05
- Results first posted
- 2011-12-19
- Limitations and caveats
- Early termination of the trial resulted in a small number of participants being analyzed, and Microperimetry (MP-1) results were not accurate for either participant due to fixation issues.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36 | Baseline and 36 Weeks | Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol. Acuity is measured as letters read on an ETDRS eye chart and the letters read equate to Snellen measurements. For example, if a participant reads between 84 and 88 letters, the equivalent Snellen measurement is 20/20. |
| Secondary | Change in Retinal Thickness From Baseline to Week 36 | Baseline and 36 Weeks | Retinal thickness was assessed by spectral-domain optical coherence tomography (Cirrus HD-OCT; Carl Zeiss Meditec, Dublin, CA), a non-invasive imaging technique that uses long-wavelength light to capture micrometer-resolution cross-sectional images from biological tissue. |
| Secondary | Reduction in Leakage Intensity as Measured by Fluorescein Angiography From Baseline to Week 36 | Baseline and 36 Weeks | Number of participants with improvement in leakage intensity. |
| Secondary | Visual Field Changes as Documented by Microperimetry From Baseline to Week 36 | Baseline and 36 Weeks | |
| Secondary | Changes in Non-ocular VHL Lesion Status | Duration of study | Count of participants with new non-ocular lesions present since baseline at any follow-up visit. |
| Secondary | Reduction in Leakage Area as Measured by Fluorescein Angiography at the Week 36 Visit | Baseline and 36 Weeks | Number of participants with improvement in leakage area. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36 | Baseline and 36 Weeks | ETDRS Letters | NUMBER | |
| SECONDARY | Change in Retinal Thickness From Baseline to Week 36 | Baseline and 36 Weeks | µm | NUMBER | |
| SECONDARY | Reduction in Leakage Intensity as Measured by Fluorescein Angiography From Baseline to Week 36 | Baseline and 36 Weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Visual Field Changes as Documented by Microperimetry From Baseline to Week 36 | Baseline and 36 Weeks | Microperimetry was not accurate for any participants due to fixation issues so no data was collected. As such, zero participants were analyzed for this outcome. | ||
| SECONDARY | Changes in Non-ocular VHL Lesion Status | Duration of study | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Reduction in Leakage Area as Measured by Fluorescein Angiography at the Week 36 Visit | Baseline and 36 Weeks | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36 | Left Eye | 1 | ETDRS Letters | ||
| Change in Best Corrected Visual Acuity (BCVA) From Baseline to Week 36 | Right Eye | -5 | ETDRS Letters | ||
| Change in Retinal Thickness From Baseline to Week 36 | Left Eye | 116 | µm | ||
| Change in Retinal Thickness From Baseline to Week 36 | Right Eye | 1 | µm | ||
| Reduction in Leakage Intensity as Measured by Fluorescein Angiography From Baseline to Week 36 | Sunitinib Malate | 1 | Participants | ||
| Changes in Non-ocular VHL Lesion Status | Sunitinib Malate | Renal / New Lesions Since Baseline | 0 | Participants | |
| Changes in Non-ocular VHL Lesion Status | Sunitinib Malate | Renal / No New Lesions Since Baseline | 1 | Participants | |
| Changes in Non-ocular VHL Lesion Status | Sunitinib Malate | Renal / N/A - Lesions Present at Baseline | 1 | Participants | |
| Changes in Non-ocular VHL Lesion Status | Sunitinib Malate | Pancreatic / New Lesions Since Baseline | 0 | Participants | |
| Changes in Non-ocular VHL Lesion Status | Sunitinib Malate | Pancreatic / No New Lesions Since Baseline | 1 | Participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sunitinib Malate | 2 | |
| Overall Study | COMPLETED | Sunitinib Malate | 0 | |
| Overall Study | NOT COMPLETED | Sunitinib Malate | 2 |
Source ClinicalTrials.gov
Adverse events53
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 | Vaginal haemorrhage | Reproductive system and breast disorders | Sunitinib Malate | 1 | 2 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | Sunitinib Malate | 1 | 2 | 3 |
| other | Dizziness | Nervous system disorders | Sunitinib Malate | 1 | 2 | 1 |
| other | Fatigue | General disorders | Sunitinib Malate | 2 | 2 | 3 |
| other | Sensitivity of teeth | Gastrointestinal disorders | Sunitinib Malate | 1 | 2 | 2 |
| other | Chills | General disorders | Sunitinib Malate | 2 | 2 | 5 |
| other | Stomatitis | Gastrointestinal disorders | Sunitinib Malate | 1 | 2 | 2 |
| other | Temperature intolerance | General disorders | Sunitinib Malate | 1 | 2 | 1 |
| other | Nail disclouration | Skin and subcutaneous tissue disorders | Sunitinib Malate | 1 | 2 | 1 |
| other | Urine analysis abnormal | Investigations | Sunitinib Malate | 1 | 2 | 1 |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sunitinib Malate | ||
| Total, other adverse events | Sunitinib Malate | 2 | 2 |
| Total, serious adverse events | Sunitinib Malate | 0 | 2 |
Source ClinicalTrials.gov
Papers40
The papers the trial lists on ClinicalTrials.gov.
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/NCT00673816
GET https://conductscience.org/api/trials/v1/NCT00673816/results?page=2