Trial · NCT00363168
Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial
NCT00363168, Phase 1, Completed, Johns Hopkins University; results first posted 2012-10-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial. Trials, record NCT00363168. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00363168
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ranibizumab in Hemorrhagic Choroidal Neovascularization Trial
- NCT number
- NCT00363168
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 7 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Choroidal Neovascularization
- Interventions
- Ranibizumab, Ranibizumab
- First posted
- 2006-08-15
- Last updated
- 2012-10-19
- Results first posted
- 2012-10-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters. | 12 months | Visual acuity measured prior to first treatment with ranibizumab and at 12 months following the first treatment were compared for each subject enrolled in the study. The 12 month follow-up visual acuity was subtracted from the baseline visual acuity. Avoiding a 15 or more letter loss in visual acuity was considered a successful outcome. |
| Secondary | Retinal Changes on Funduscopy | 12 months | |
| Secondary | Retinal Thickness Measured by Optical Coherence Tomography (OCT) | 12 months | |
| Secondary | Fluorescein Leakage on Fluorescein Angiography | 12 months | |
| Secondary | Number of Subjects Experiencing Complications Related to Drug or Its Administration | 12 months after last injection | Potential complications included: * Deterioration of best-corrected visual acuity by 3 or more lines * Development of intraocular inflammation * Development of elevated intraocular pressure * Development of other ocular or systemic adverse effects. Subjects were monitored for potential drug-related ocular adverse effects: intraocular inflammation (uveitis), endophthalmitis, central retinal vein occlusion, transient elevation of IOP, acute reduction in the visual acuity, vitreous hemorrhage, injection-site pain, retinal hemorrhage, posterior vitreous detachment, and subconjunctival hemorrhage. Subjects were monitored for potential adverse effects of intravitreal injections: crystalline lens penetration, retinal break and/or detachment, vitreous hemorrhage, inflammation, and infection. Potential systemic adverse effects were captured by monitoring vital functions such as cardiovascular function, nervous system function, renal function, and gastrointestinal function. |
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 | Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters. | 12 months | participants | NUMBER | |
| SECONDARY | Retinal Changes on Funduscopy | 12 months | |||
| SECONDARY | Retinal Thickness Measured by Optical Coherence Tomography (OCT) | 12 months | |||
| SECONDARY | Fluorescein Leakage on Fluorescein Angiography | 12 months | |||
| SECONDARY | Number of Subjects Experiencing Complications Related to Drug or Its Administration | 12 months after last injection | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters. | Ranibizumab Dose A | 5 | participants | ||
Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters. | Ranibizumab Dose B | 2 | participants | ||
| Number of Subjects Experiencing Complications Related to Drug or Its Administration | Ranibizumab Dose A | 0 | participants | ||
| Number of Subjects Experiencing Complications Related to Drug or Its Administration | Ranibizumab Dose B | 0 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ranibizumab Dose A | 5 | |
| Overall Study | STARTED | Ranibizumab Dose B | 2 | |
| Overall Study | COMPLETED | Ranibizumab Dose A | 5 | |
| Overall Study | COMPLETED | Ranibizumab Dose B | 2 | |
| Overall Study | NOT COMPLETED | Ranibizumab Dose A | 0 | |
| Overall Study | NOT COMPLETED | Ranibizumab Dose B | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranibizumab Dose A | ||
| Total, all-cause mortality | Ranibizumab Dose B | ||
| Total, other adverse events | Ranibizumab Dose A | 0 | 5 |
| Total, other adverse events | Ranibizumab Dose B | 0 | 2 |
| Total, serious adverse events | Ranibizumab Dose A | 0 | 5 |
| Total, serious adverse events | Ranibizumab Dose B | 0 | 2 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20827138 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Ranibizumab Dose A vs Ranibizumab Dose B: Number of Subjects Avoiding 15 or More Letter Loss of Best Corrected Visual Acuity From Baseline to 12 Months on an Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart Measured at 4 Meters. | Trial comparisons |
| Ranibizumab Dose A vs Ranibizumab Dose B: Number of Subjects Experiencing Complications Related to Drug or Its Administration | Trial comparisons |
| Ranibizumab Dose A vs Ranibizumab Dose B: 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/NCT00363168
GET https://conductscience.org/api/trials/v1/NCT00363168/registered