Trial · NCT01449682

Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections.

NCT01449682, Phase 3, Completed, Retina Macula Institute; results first posted 2017-05-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections. Trials, record NCT01449682. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01449682

On this page

Trial

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

Title: Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections.
NCT number: NCT01449682
Status: Completed
Phases: Phase 3
Enrollment: 10 participants, actual
Lead sponsor: Retina Macula Institute
Conditions: Retinal Vein Occlusion, Macular Edema
Interventions: Ozurdex, Ozurdex
First posted: 2011-10-10
Last updated: 2017-05-31
Results first posted: 2017-05-31

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Macular Function Using Microperimetry	baseline to 48 weeks	To determine if there is change in mean macular sensitivity using microperimetry at 48 weeks compared to baseline for both the PRN and Q16weeks treatment groups
Primary	Macular Function Using Multi-focal ERG	baseline to 48 weeks	To determine if there is a change in central amplitude responses using multifocal ERG at 48 weeks compared to baseline values for both the PRN and Q16weeks treatment groups
Secondary	To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups	baseline to 48 weeks
Secondary	To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups	baseline to 48 weeks

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Macular Function Using Microperimetry	baseline to 48 weeks	dB	MEAN
PRIMARY	Macular Function Using Multi-focal ERG	baseline to 48 weeks	nV/deg2	MEAN
SECONDARY	To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups	baseline to 48 weeks	ETDRS letters	MEAN
SECONDARY	To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups	baseline to 48 weeks	microns	MEAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Macular Function Using Microperimetry	Ozurdex PRN	Baseline	2.7	Standard Error 0.8	dB
Macular Function Using Microperimetry	Ozurdex Q16 Weeks	Baseline	12.7	Standard Error 2.6	dB
Macular Function Using Microperimetry	Ozurdex PRN	Final Visit	4.2	Standard Error 1.7	dB
Macular Function Using Microperimetry	Ozurdex Q16 Weeks	Final Visit	10.7	Standard Error 1.9	dB
Macular Function Using Multi-focal ERG	Ozurdex PRN	Baseline	3.61	Standard Error 0.39	nV/deg2
Macular Function Using Multi-focal ERG	Ozurdex Q16 Weeks	Baseline	6.62	Standard Error 0.83	nV/deg2
Macular Function Using Multi-focal ERG	Ozurdex PRN	Final Visit	18.20	Standard Error 4.03	nV/deg2
Macular Function Using Multi-focal ERG	Ozurdex Q16 Weeks	Final Visit	30.18	Standard Error 9.60	nV/deg2
To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups	Ozurdex PRN	Baseline	46.4	Standard Error 7.1	ETDRS letters
To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups	Ozurdex Q16 Weeks	Baseline	55.6	Standard Error 7.5	ETDRS letters

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Active Comparator: Ozurdex PRN	5
Overall Study	STARTED	Active Comparator: Ozurdex q16 Weeks	5
Overall Study	COMPLETED	Active Comparator: Ozurdex PRN	4
Overall Study	COMPLETED	Active Comparator: Ozurdex q16 Weeks	4
Overall Study	NOT COMPLETED	Active Comparator: Ozurdex PRN	1
Overall Study	NOT COMPLETED	Active Comparator: Ozurdex q16 Weeks	1

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	Elevated Intraocular Pressure	Eye disorders	Ozurdex PRN	0	5	0
other	Elevated Intraocular Pressure	Eye disorders	Ozurdex Q16 Weeks	1	5	1
serious	Cataract Requiring Emergent Surgery	Eye disorders	Ozurdex PRN	1	5	1
serious	Cataract Requiring Emergent Surgery	Eye disorders	Ozurdex Q16 Weeks	0	5	0

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ozurdex PRN	0	5
Total, all-cause mortality	Ozurdex Q16 Weeks	1	5
Total, other adverse events	Ozurdex PRN	0	5
Total, other adverse events	Ozurdex Q16 Weeks	1	5
Total, serious adverse events	Ozurdex PRN	1	5
Total, serious adverse events	Ozurdex Q16 Weeks	0	5

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 comparisons2

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

Comparison	Source
Ozurdex PRN vs Ozurdex Q16 Weeks: deaths from any cause	Trial comparisons
Ozurdex PRN vs Ozurdex Q16 Weeks: 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.

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/NCT01449682

GET https://conductscience.org/api/trials/v1/NCT01449682/registered

API reference For AI assistants