Trial · NCT00498355
Lucentis for Inflammatory Macular Edema Trial
NCT00498355, Phase 1, Phase 2, Completed, University of California, San Francisco; results first posted 2012-09-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lucentis for Inflammatory Macular Edema Trial. Trials, record NCT00498355. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00498355
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lucentis for Inflammatory Macular Edema Trial
- NCT number
- NCT00498355
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- University of California, San Francisco
- Conditions
- Uveitis, Cytoid Macular Edema
- Interventions
- Ranibizumab
- First posted
- 2007-07-10
- Last updated
- 2017-11-30
- Results first posted
- 2012-09-21
- Limitations and caveats
- Limitations of the study include a small sample size and lack of a control group.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Mean Change at 3 Months in BSCVA From Baseline | baseline and 3 months | The outcome measure was mean best spectacle-corrected visual acuity (BSCVA). In this study, BSCVA was measured after trial frame manifest refraction, using high-contrast modified Bailey-Lovie (ETDRS) charts at 4 meters. The charts were placed in a retro-illuminated light box equipped with two 20-watt fluorescent tubes. The highest attainable 4-meter visual acuity score is 100 letters. |
| Secondary | The Median Change in Best Corrected Visual Acuity From 6 to12 Months | 6 to 12 months | |
| Secondary | The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12 | 7 days, and at months 3, 6, 9, and 12 | |
| Secondary | The Incidence of Uveitis Flares (> 2+ Cells in the Anterior Chamber or Vitreous) | Study duration | |
| Secondary | The Incidence of Ocular and Non-ocular Adverse Events | Study duration |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Mean Change at 3 Months in BSCVA From Baseline | baseline and 3 months | 6 patients completed all assessment points. One patient decided not to continue for nonmedical reasons, but they did complete the baseline, 1-week and 1-month assessment. | letters | MEAN |
| SECONDARY | The Median Change in Best Corrected Visual Acuity From 6 to12 Months | 6 to 12 months | Letters | MEDIAN | |
| SECONDARY | The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12 | 7 days, and at months 3, 6, 9, and 12 | microns | MEAN | |
| SECONDARY | The Incidence of Uveitis Flares (> 2+ Cells in the Anterior Chamber or Vitreous) | Study duration | uveitis flares | NUMBER | |
| SECONDARY | The Incidence of Ocular and Non-ocular Adverse Events | Study duration | adverse events | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Mean Change at 3 Months in BSCVA From Baseline | Ranibizumab for Macular Edema | 13 | Full Range 3 to 24 | letters | |
| The Median Change in Best Corrected Visual Acuity From 6 to12 Months | Ranibizumab | -2 | Full Range -6 to 2 | Letters | |
| The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12 | Ranibizumab | Week 7 | -267 | Full Range -620 to -158 | microns |
| The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12 | Ranibizumab | Month 3 | -356 | Full Range -1034 to -95 | microns |
| The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12 | Ranibizumab | Month 6 | -354 | Full Range -1053 to -85 | microns |
| The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12 | Ranibizumab | Month 9 | -243 | Full Range -941 to 222 | microns |
| The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at Months 3, 6, 9, and 12 | Ranibizumab | Month 12 | -388 | Full Range -1026 to 12 | microns |
| The Incidence of Uveitis Flares (> 2+ Cells in the Anterior Chamber or Vitreous) | Ranibizumab | 0 | uveitis flares | ||
| The Incidence of Ocular and Non-ocular Adverse Events | Ranibizumab | 4 | adverse events |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ranibizumab for Macular Edema | 7 | |
| Overall Study | COMPLETED | Ranibizumab for Macular Edema | 6 | |
| Overall Study | NOT COMPLETED | Ranibizumab for Macular Edema | 1 |
Source ClinicalTrials.gov
Adverse events1
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 | Subconjunctival Hemorrhage | Eye disorders | Ranibizumab for Macular Edema | 4 | 7 | 4 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranibizumab for Macular Edema | ||
| Total, other adverse events | Ranibizumab for Macular Edema | 4 | 7 |
| Total, serious adverse events | Ranibizumab for Macular Edema | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00498355
GET https://conductscience.org/api/trials/v1/NCT00498355/registered