Trial · NCT01805323
A Retrospective Chart Review of OZURDEX® in Patients With Macular Edema
NCT01805323, Completed, Allergan; results first posted 2014-05-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Retrospective Chart Review of OZURDEX® in Patients With Macular Edema. Trials, record NCT01805323. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01805323
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Retrospective Chart Review of OZURDEX® in Patients With Macular Edema
- NCT number
- NCT01805323
- Status
- Completed
- Enrollment
- 101 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Macular Edema
- Interventions
- Dexamethasone Intravitreal Implant
- First posted
- 2013-03-06
- Last updated
- 2019-04-17
- Results first posted
- 2014-05-30
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) | Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months) | BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The peak mean change in BCVA was calculated using the most improved number of lines read correctly between 2 and 26 weeks following the last available injection of OZURDEX® - the number of lines read correctly at Baseline. A positive change from Baseline indicated improvement. |
| Secondary | Peak Mean Change From Baseline in Central Retinal Thickness (CRT) | Baseline, 2 to 26 weeks following last injection (up to 6.5 months) | Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye. The peak mean change was the maximum change from Baseline in CRT at 2 to 26 weeks following the last available injection of OZURDEX®. A negative change from Baseline indicated improvement. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) | Baseline, 2 to 26 weeks (wks) following last injection (up to 6.5 months) | All participants with BCVA observations available following the last OZURDEX® injection from 2 to 26 weeks. | Lines | MEAN |
| SECONDARY | Peak Mean Change From Baseline in Central Retinal Thickness (CRT) | Baseline, 2 to 26 weeks following last injection (up to 6.5 months) | All participants with CRT observations available following the last OZURDEX® injection from 2 to 26 weeks. | microns (μm) | MEAN |
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 |
|---|---|---|---|---|---|
| Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) | All Participants | Baseline | 6.3 | Standard Error 0.3 | Lines |
| Peak Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) | All Participants | Change from Baseline 2-26 wks after last injection | 1.4 | Standard Error 0.3 | Lines |
| Peak Mean Change From Baseline in Central Retinal Thickness (CRT) | All Participants | Baseline | 474.4 | Standard Error 18.2 | microns (μm) |
| Peak Mean Change From Baseline in Central Retinal Thickness (CRT) | All Participants | Change from Baseline 2-26 wks after last injection | -183.4 | Standard Error 17.9 | microns (μm) |
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 | All Participants | 101 | |
| Overall Study | COMPLETED | All Participants | 101 | |
| Overall Study | NOT COMPLETED | All Participants | 0 |
Source ClinicalTrials.gov
Adverse events6
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 | Intraocular pressure increased | Investigations | All Participants | 19 | 101 | |
| other | Cystoid macular oedema | Eye disorders | All Participants | 6 | 101 | |
| serious | Endophthalmitis | Eye disorders | All Participants | 1 | 101 | |
| serious | Uveitis | Eye disorders | All Participants | 1 | 101 | |
| serious | Retinal detachment | Injury, poisoning and procedural complications | All Participants | 1 | 101 | |
| serious | Retinal implant | Surgical and medical procedures | All Participants | 1 | 101 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | ||
| Total, other adverse events | All Participants | 25 | 101 |
| Total, serious adverse events | All Participants | 4 | 101 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26203215 | BACKGROUND |
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 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/NCT01805323
GET https://conductscience.org/api/trials/v1/NCT01805323/registered