Trial · NCT01492400

Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema

NCT01492400, Phase 2, Completed, Allergan; results first posted 2015-01-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema. Trials, record NCT01492400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01492400

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Trial

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

Title: Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema
NCT number: NCT01492400
Status: Completed
Phases: Phase 2
Enrollment: 363 participants, actual
Lead sponsor: Allergan
Conditions: Macular Edema
Interventions: dexamethasone Intravitreal Implant, ranibizumab
First posted: 2011-12-15
Last updated: 2019-04-17
Results first posted: 2015-01-29

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	Baseline, 12 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 Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye	Baseline, Month 12	OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the fovea (part of the retina) in the study eye after pupil dilation. A negative change from baseline indicates an improvement (less foveal thickness) and a positive change from baseline indicates a worsening (more foveal thickness).
Secondary	Change From Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA)	Baseline, Month 12	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. A negative change from baseline indicates a decrease in leakage (improvement) and a positive change from baseline indicates an increase in leakage (worsening).

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	Baseline, 12 Months	Intent-to-Treat: all randomized patients	Letters	MEAN
SECONDARY	Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye	Baseline, Month 12	Intent-to-Treat: all randomized patients	Microns	MEAN
SECONDARY	Change From Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA)	Baseline, Month 12	Intent-to-Treat: all randomized patients	Square Millimeters (mm^2)	MEAN

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Category	Value	Spread	Units
Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	Dexamethasone Intravitreal Implant	Baseline	60.2	Standard Deviation 9.74	Letters
Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	Ranibizumab	Baseline	60.4	Standard Deviation 9.34	Letters
Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	Dexamethasone Intravitreal Implant	Change from Baseline at 12 Months	4.34	Standard Deviation 7.342	Letters
Average Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	Ranibizumab	Change from Baseline at 12 Months	7.60	Standard Deviation 6.735	Letters
Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye	Dexamethasone Intravitreal Implant	Baseline	465.1	Standard Deviation 136.09	Microns
Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye	Ranibizumab	Baseline	471.2	Standard Deviation 139.51	Microns
Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye	Dexamethasone Intravitreal Implant	Change from Baseline at Month 12 (N=163, 166)	-173.9	Standard Deviation 129.64	Microns
Change From Baseline in Foveal Thickness Measured by Optical Coherence Tomography (OCT) in the Study Eye	Ranibizumab	Change from Baseline at Month 12 (N=163, 166)	-163.5	Standard Deviation 161.34	Microns
Change From Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA)	Dexamethasone Intravitreal Implant	Baseline	19.2	Standard Deviation 13.01	Square Millimeters (mm^2)
Change From Baseline in Total Area of Macular Leakage in the Study Eye Measured on Fluorescein Angiography (FA)	Ranibizumab	Baseline	18.9	Standard Deviation 12.55	Square Millimeters (mm^2)

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Dexamethasone Intravitreal Implant	181
Overall Study	STARTED	Ranibizumab	182
Overall Study	COMPLETED	Dexamethasone Intravitreal Implant	165
Overall Study	COMPLETED	Ranibizumab	166
Overall Study	NOT COMPLETED	Dexamethasone Intravitreal Implant	16
Overall Study	NOT COMPLETED	Ranibizumab	16

Source ClinicalTrials.gov

Adverse events236

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	Anaemia	Blood and lymphatic system disorders	Dexamethasone Intravitreal Implant	6	181
other	Anaemia	Blood and lymphatic system disorders	Ranibizumab	10	182
other	Conjunctival Haemorrhage	Eye disorders	Dexamethasone Intravitreal Implant	36	181
other	Conjunctival Haemorrhage	Eye disorders	Ranibizumab	24	182
other	Cataract	Eye disorders	Dexamethasone Intravitreal Implant	28	181
other	Cataract	Eye disorders	Ranibizumab	8	182
other	Vitreous Haemorrhage	Eye disorders	Dexamethasone Intravitreal Implant	22	181
other	Vitreous Haemorrhage	Eye disorders	Ranibizumab	7	182
other	Visual Acuity Reduced	Eye disorders	Dexamethasone Intravitreal Implant	14	181
other	Visual Acuity Reduced	Eye disorders	Ranibizumab	5	182

1 to 10 of 236Source ClinicalTrials.gov

See all 236 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dexamethasone Intravitreal Implant
Total, all-cause mortality	Ranibizumab
Total, other adverse events	Dexamethasone Intravitreal Implant	160	181
Total, other adverse events	Ranibizumab	104	182
Total, serious adverse events	Dexamethasone Intravitreal Implant	40	181
Total, serious adverse events	Ranibizumab	41	182

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27632215	BACKGROUND	PubMed
30293228	DERIVED	PubMed
33206392	DERIVED	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
Dexamethasone Intravitreal Implant vs Ranibizumab: 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/NCT01492400

GET https://conductscience.org/api/trials/v1/NCT01492400/events?page=2

API reference For AI assistants