Trial · NCT00168324
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
NCT00168324, Phase 3, Completed, Allergan; results first posted 2009-08-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion. Trials, record NCT00168324. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00168324
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
- NCT number
- NCT00168324
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 599 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Interventions
- 700 µg Dexamethasone, 350 µg Dexamethasone, Sham Injection
- First posted
- 2005-09-15
- Last updated
- 2019-04-23
- Results first posted
- 2009-08-26
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cumulative Response Rate of 15 or More Letter Improvement | Up to 180 Days | The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response. |
| Secondary | Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye | Day 90, Day 180 | 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. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye at each visit are presented. |
| Secondary | Change From Baseline in Retinal Thickness in the Study Eye | Baseline, Day 90, Day 180 | Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement. |
| Secondary | Percentage of Patients With a Change From Baseline in BCVA by Category | Baseline, Day 90 | 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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and \<15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and \<15 Letters Worsening, and ≥15 Letters Worsening. |
| Secondary | Percentage of Patients With a Change From Baseline in BCVA by Category | Baseline, Day 180 | 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. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and \<15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and \<15 Letters Worsening, and ≥15 Letters Worsening. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye | Day 90, Day 180 | Intent-to-Treat: all randomized patients | Number of Participants | NUMBER |
| SECONDARY | Change From Baseline in Retinal Thickness in the Study Eye | Baseline, Day 90, Day 180 | Intent-to-Treat: all randomized patients | Microns (µm) | MEAN |
| PRIMARY | Cumulative Response Rate of 15 or More Letter Improvement | Up to 180 Days | Intent-to-Treat: all randomized patients | Kaplan-Meier Estimate | NUMBER |
| SECONDARY | Percentage of Patients With a Change From Baseline in BCVA by Category | Baseline, Day 90 | Intent-to-Treat: all randomized patients | Percentage of Patients | NUMBER |
| SECONDARY | Percentage of Patients With a Change From Baseline in BCVA by Category | Baseline, Day 180 | Intent-to-Treat: all randomized patients | Percentage of Patients | NUMBER |
Source ClinicalTrials.gov
Results by group57
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye | 700 µg Dexamethasone | Day 90 | 45 | Number of Participants | |
| Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye | 350 µg Dexamethasone | Day 90 | 41 | Number of Participants | |
| Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye | Sham Injection | Day 90 | 25 | Number of Participants | |
| Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye | 700 µg Dexamethasone | Day 180 | 39 | Number of Participants | |
| Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye | 350 µg Dexamethasone | Day 180 | 32 | Number of Participants | |
| Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye | Sham Injection | Day 180 | 37 | Number of Participants | |
| Change From Baseline in Retinal Thickness in the Study Eye | 700 µg Dexamethasone | Baseline | 548.9 | Standard Deviation 185.45 | Microns (µm) |
| Change From Baseline in Retinal Thickness in the Study Eye | 350 µg Dexamethasone | Baseline | 541.6 | Standard Deviation 183.68 | Microns (µm) |
| Change From Baseline in Retinal Thickness in the Study Eye | Sham Injection | Baseline | 534.4 | Standard Deviation 187.38 | Microns (µm) |
| Change From Baseline in Retinal Thickness in the Study Eye | 700 µg Dexamethasone | Change from Baseline at Day 90 | -199.3 | Standard Deviation 194.54 | Microns (µm) |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Period | STARTED | 700 µg Dexamethasone | 201 | |
| Double-Blind Period | STARTED | 350 µg Dexamethasone Followed by 700 µg Dexamethasone | 196 | |
| Double-Blind Period | STARTED | Sham Injection Followed by 700 µg Dexamethasone | 202 | |
| Double-Blind Period | COMPLETED | 700 µg Dexamethasone | 189 | |
| Double-Blind Period | COMPLETED | 350 µg Dexamethasone Followed by 700 µg Dexamethasone | 189 | |
| Double-Blind Period | COMPLETED | Sham Injection Followed by 700 µg Dexamethasone | 189 | |
| Double-Blind Period | NOT COMPLETED | 700 µg Dexamethasone | 12 | |
| Double-Blind Period | NOT COMPLETED | 350 µg Dexamethasone Followed by 700 µg Dexamethasone | 7 | |
| Double-Blind Period | NOT COMPLETED | Sham Injection Followed by 700 µg Dexamethasone | 13 | |
| Open-Label Period | STARTED | 700 µg Dexamethasone | 164 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events132
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 | Conjunctival haemorrhage | Eye disorders | 700 µg Dexamethasone | 39 | 196 | |
| other | Conjunctival haemorrhage | Eye disorders | 350 µg Dexamethasone | 35 | 197 | |
| other | Conjunctival haemorrhage | Eye disorders | Sham Injection | 26 | 202 | |
| other | Eye pain | Eye disorders | 700 µg Dexamethasone | 13 | 196 | |
| other | Eye pain | Eye disorders | 350 µg Dexamethasone | 8 | 197 | |
| other | Eye pain | Eye disorders | Sham Injection | 7 | 202 | |
| other | Maculopathy | Eye disorders | 700 µg Dexamethasone | 11 | 196 | |
| other | Maculopathy | Eye disorders | 350 µg Dexamethasone | 7 | 197 | |
| other | Maculopathy | Eye disorders | Sham Injection | 17 | 202 | |
| other | Conjunctival hyperaemia | Eye disorders | 700 µg Dexamethasone | 10 | 196 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 700 µg Dexamethasone | ||
| Total, all-cause mortality | 350 µg Dexamethasone | ||
| Total, all-cause mortality | Sham Injection | ||
| Total, other adverse events | 700 µg Dexamethasone | 119 | 196 |
| Total, other adverse events | 350 µg Dexamethasone | 107 | 197 |
| Total, other adverse events | Sham Injection | 63 | 202 |
| Total, serious adverse events | 700 µg Dexamethasone | 12 | 196 |
| Total, serious adverse events | 350 µg Dexamethasone | 28 | 197 |
| Total, serious adverse events | Sham Injection | 14 | 202 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20417567 | 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/NCT00168324
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