Trial · NCT01122511
Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration
NCT01122511, Phase 2, Terminated, Allergan; results first posted 2012-09-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration. Trials, record NCT01122511. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01122511
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration
- NCT number
- NCT01122511
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Subfoveal Choroidal Neovascularization, Age-Related Maculopathy
- Interventions
- 700 ug dexamethasone, ranibizumab, sham
- First posted
- 2010-05-13
- Last updated
- 2012-09-05
- Results first posted
- 2012-09-05
- Limitations and caveats
- The study was terminated early due to difficulties with patient recruitment. No participants reached the 12 month time-point. Efficacy analyses were not performed.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12 | Baseline, Month 12 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. |
| Secondary | The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12 | Baseline, Month 12 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. |
| Secondary | Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography | Baseline, Month 12 | Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Month 12. |
| Secondary | Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography | Baseline, Month 12 | Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the study eye after dilation at baseline and Week 12. |
Source ClinicalTrials.gov
Outcomes4
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 Best Corrected Visual Acuity (BCVA) at Month 12 | Baseline, Month 12 | No participants reached the 12 month time-point. Efficacy analyses were not performed. | ||
| SECONDARY | The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12 | Baseline, Month 12 | No participants reached the 12 month time-point. Efficacy analyses were not performed. | ||
| SECONDARY | Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography | Baseline, Month 12 | No participants reached the 12 month time-point. Efficacy analyses were not performed. | ||
| SECONDARY | Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography | Baseline, Month 12 | No participants reached the 12 month time-point. Efficacy analyses were not performed. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dexamethasone and Ranibizumab | 2 | |
| Overall Study | STARTED | Ranibizumab and Sham | 2 | |
| Overall Study | COMPLETED | Dexamethasone and Ranibizumab | 0 | |
| Overall Study | COMPLETED | Ranibizumab and Sham | 0 | |
| Overall Study | NOT COMPLETED | Dexamethasone and Ranibizumab | 2 | |
| Overall Study | NOT COMPLETED | Ranibizumab and Sham | 2 |
Source ClinicalTrials.gov
Adverse events4
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 | Tooth Disorder | Gastrointestinal disorders | Dexamethasone and Ranibizumab | 1 | 2 | |
| other | Tooth Disorder | Gastrointestinal disorders | Ranibizumab and Sham | 0 | 2 | |
| other | Retinal oedema | Eye disorders | Dexamethasone and Ranibizumab | 0 | 2 | |
| other | Retinal oedema | Eye disorders | Ranibizumab and Sham | 1 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dexamethasone and Ranibizumab | ||
| Total, all-cause mortality | Ranibizumab and Sham | ||
| Total, other adverse events | Dexamethasone and Ranibizumab | 1 | 2 |
| Total, other adverse events | Ranibizumab and Sham | 1 | 2 |
| Total, serious adverse events | Dexamethasone and Ranibizumab | 0 | 2 |
| Total, serious adverse events | Ranibizumab and Sham | 0 | 2 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dexamethasone and Ranibizumab vs Ranibizumab and Sham: serious adverse events |
Source 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/NCT01122511
GET https://conductscience.org/api/trials/v1/NCT01122511/registered