Trial · NCT00826618
Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema
NCT00826618, Phase 1, Completed, University of Miami; results first posted 2014-08-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema. Trials, record NCT00826618. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00826618
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study of Ranibizumab (Lucentis) for Uveitic Cystoid Macular Edema
- NCT number
- NCT00826618
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 6 participants, actual
- Lead sponsor
- University of Miami
- Conditions
- Uveitic Cystoid Macular Edema
- Interventions
- ranibizumab
- First posted
- 2009-01-22
- Last updated
- 2014-08-26
- Results first posted
- 2014-08-26
- Limitations and caveats
The main limitation of this study is the small number of patients.There is no comparative arm to better define the relative efficacy of ranibizumab as compared with intraocular steroids or other treatments.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS at 4 Meters) at 12 Months. | 1 year | Mean change in best corrected visual acuity (assessed by the ETDRS chart at 4 m) from baseline at 12 months following first intravitreal injection of ranibizumab was 12.2 ETDRS letters (P = 0.015). |
| Secondary | The Mean Change in Best Corrected Visual Acuity (BCVA) (Assessed by the ETDRS Chart at 4 Meters) From Baseline at 12 Months Will be Computed With a T-test. | 1 year | |
| Secondary | The Percentage of Patients With 15 Letters (3 Lines) of Visual Acuity Improvement at 30, 60, 90, 120 Days, and 12 Months. | 1 year | |
| Secondary | The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at 30, 60, 90, 120 Days, and 12 Months Will be Computed Using a T-test. | 1 year | |
| Secondary | The Incidence of Ocular and Non-ocular Adverse Events Will be Evaluated Through Month 24. | 2 years |
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 | Change From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS at 4 Meters) at 12 Months. | 1 year | Change in ETDRS Letters | MEAN | |
| SECONDARY | The Mean Change in Best Corrected Visual Acuity (BCVA) (Assessed by the ETDRS Chart at 4 Meters) From Baseline at 12 Months Will be Computed With a T-test. | 1 year | |||
| SECONDARY | The Percentage of Patients With 15 Letters (3 Lines) of Visual Acuity Improvement at 30, 60, 90, 120 Days, and 12 Months. | 1 year | |||
| SECONDARY | The Mean Change in Foveal Retinal Thickness From Baseline at 7 Days, and at 30, 60, 90, 120 Days, and 12 Months Will be Computed Using a T-test. | 1 year | |||
| SECONDARY | The Incidence of Ocular and Non-ocular Adverse Events Will be Evaluated Through Month 24. | 2 years |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS at 4 Meters) at 12 Months. | Ranibizumab | 12.2 | Standard Deviation 6.7 | Change in ETDRS Letters |
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 | 6 | |
| Overall Study | COMPLETED | Ranibizumab | 5 | |
| Overall Study | NOT COMPLETED | Ranibizumab | 1 |
Source ClinicalTrials.gov
Adverse events10
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 | Floaters | Eye disorders | Ranibizumab | 3 | 5 | |
| other | Eye Pain | Eye disorders | Ranibizumab | 2 | 5 | |
| other | Blurry Vision | Eye disorders | Ranibizumab | 2 | 5 | |
| other | Uveitis in fellow eye | Eye disorders | Ranibizumab | 2 | 5 | |
| other | Anterior uveitis | Eye disorders | Ranibizumab | 1 | 5 | |
| other | Dry Eye | Eye disorders | Ranibizumab | 1 | 5 | |
| other | Cataract | Eye disorders | Ranibizumab | 1 | 5 | |
| other | Glaucoma | Eye disorders | Ranibizumab | 1 | 5 | |
| other | Ocular pruritis | Eye disorders | Ranibizumab | 1 | 5 | |
| other | Tachycardia | Cardiac disorders | Ranibizumab | 1 | 5 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranibizumab | ||
| Total, other adverse events | Ranibizumab | 5 | 5 |
| Total, serious adverse events | Ranibizumab | 0 | 5 |
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/NCT00826618
GET https://conductscience.org/api/trials/v1/NCT00826618/registered