Trial · NCT01660802

Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)

NCT01660802, Phase 3, Completed, Allergan; results first posted 2015-06-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO). Trials, record NCT01660802. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01660802

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)
NCT number: NCT01660802
Status: Completed
Phases: Phase 3
Enrollment: 262 participants, actual
Lead sponsor: Allergan
Conditions: Macular Edema
Interventions: 700 μg Dexamethasone, Sham
First posted: 2012-08-09
Last updated: 2019-04-17
Results first posted: 2015-06-08

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye	Baseline, 6 Months	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 are presented.
Secondary	Average Change From Baseline in BCVA in the Study Eye	Baseline, 6 Months	BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.
Secondary	Change From Baseline in BCVA in the Study Eye	Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6	BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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. A decrease in the number of letters read correctly (negative number) means that vision has worsened.
Secondary	Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye	Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6	BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. 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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening.

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	Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye	Baseline, 6 Months	Modified Intent-to-Treat: all randomized and treated patients	Patients	NUMBER
SECONDARY	Average Change From Baseline in BCVA in the Study Eye	Baseline, 6 Months	Modified Intent-to-Treat: all randomized and treated patients	Letters Read Correctly	MEAN
SECONDARY	Change From Baseline in BCVA in the Study Eye	Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6	Modified Intent-to-Treat: all randomized and treated patients	Letters Read Correctly	MEAN
SECONDARY	Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye	Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6	Modified Intent-to-Treat: all randomized and treated patients	Percentage of Patients	NUMBER

Source ClinicalTrials.gov

Results by group32

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		60		Patients
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye	Sham		31		Patients
Average Change From Baseline in BCVA in the Study Eye	700 μg Dexamethasone	Baseline	52.6	Standard Deviation 10.79	Letters Read Correctly
Average Change From Baseline in BCVA in the Study Eye	Sham	Baseline	53.1	Standard Deviation 10.47	Letters Read Correctly
Average Change From Baseline in BCVA in the Study Eye	700 μg Dexamethasone	Average Change from Baseline Over 6 Months	6.6	Standard Deviation 8.98	Letters Read Correctly
Average Change From Baseline in BCVA in the Study Eye	Sham	Average Change from Baseline Over 6 Months	2.5	Standard Deviation 9.98	Letters Read Correctly
Change From Baseline in BCVA in the Study Eye	700 μg Dexamethasone	Baseline	52.6	Standard Deviation 10.79	Letters Read Correctly
Change From Baseline in BCVA in the Study Eye	Sham	Baseline	53.1	Standard Deviation 10.47	Letters Read Correctly
Change From Baseline in BCVA in the Study Eye	700 μg Dexamethasone	Change from Baseline at Month 1	9.1	Standard Deviation 8.45	Letters Read Correctly
Change From Baseline in BCVA in the Study Eye	Sham	Change from Baseline at Month 1	2.0	Standard Deviation 9.28	Letters Read Correctly

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	700 μg Dexamethasone	130
Overall Study	STARTED	Sham	132
Overall Study	COMPLETED	700 μg Dexamethasone	126
Overall Study	COMPLETED	Sham	121
Overall Study	NOT COMPLETED	700 μg Dexamethasone	4
Overall Study	NOT COMPLETED	Sham	11

Source ClinicalTrials.gov

Adverse events12

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
other	Conjunctival Haemorrhage	Eye disorders	700 μg Dexamethasone	24	129
other	Conjunctival Haemorrhage	Eye disorders	Sham	5	130
other	Conjunctival Hyperaemia	Eye disorders	700 μg Dexamethasone	17	129
other	Conjunctival Hyperaemia	Eye disorders	Sham	6	130
other	Intraocular Pressure Increased	Investigations	700 μg Dexamethasone	38	129
other	Intraocular Pressure Increased	Investigations	Sham	4	130
serious	Atrioventricular Block	Cardiac disorders	700 μg Dexamethasone	1	129
serious	Atrioventricular Block	Cardiac disorders	Sham	0	130
serious	Cholecystitis Chronic	Hepatobiliary disorders	700 μg Dexamethasone	0	129
serious	Cholecystitis Chronic	Hepatobiliary disorders	Sham	1	130

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	700 μg Dexamethasone
Total, all-cause mortality	Sham
Total, other adverse events	700 μg Dexamethasone	69	129
Total, other adverse events	Sham	15	130
Total, serious adverse events	700 μg Dexamethasone	1	129
Total, serious adverse events	Sham	2	130

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29119239	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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
700 μg Dexamethasone vs 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01660802

GET https://conductscience.org/api/trials/v1/NCT01660802/results?page=2

API reference For AI assistants