Trial · NCT00511706

Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With Age-Related Macular Degeneration (AMD)

NCT00511706, Phase 2, Completed, Allergan; results first posted 2012-09-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With Age-Related Macular Degeneration (AMD). Trials, record NCT00511706. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00511706

On this page

Trial

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

Title: Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With Age-Related Macular Degeneration (AMD)
NCT number: NCT00511706
Status: Completed
Phases: Phase 2
Enrollment: 243 participants, actual
Lead sponsor: Allergan
Conditions: Choroidal Neovascularization, Age-Related Maculopathy
Interventions: dexamethasone, ranibizumab, sham
First posted: 2007-08-06
Last updated: 2019-04-25
Results first posted: 2012-09-03

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Injection Free Interval	Week 1 to Week 25	The injection free interval was defined as the number of days between receiving the second ranibizumab injection (day 7 to 14) to the investigator's determination of eligibility to receive a third ranibizumab injection in the study eye.
Secondary	Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25	Baseline, Week 25	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.
Secondary	Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye	Baseline, Week 25	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 after pupil dilation at baseline and Month 25.
Secondary	Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye	Screening (-Week 28), Week 25	Fluorescein angiography (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. FA was performed on the study eye after dilation at Screening and Week 25.

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	Injection Free Interval	Week 1 to Week 25	Intent-to-treat population consisted of all randomized patients.	Days	MEDIAN
SECONDARY	Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25	Baseline, Week 25	Participants from the Intent-to-treat population (all randomized patients) with data available at Baseline and Week 25 for analyses.	Letters	MEAN
SECONDARY	Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye	Baseline, Week 25	Participants from the Intent-to-treat population (all randomized patients) with data available at Baseline and Week 25 for analyses.	Microns	MEAN
SECONDARY	Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye	Screening (-Week 28), Week 25	Participants from the intent-to-treat population (all randomized participants) with data available at Screening and Week 25 for analyses.	Millimeters square (MM^2)	MEAN

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Category	Value	Spread	Units
Injection Free Interval	Dexamethasone and Ranibizumab		34	Inter-Quartile Range 28 to 85	Days
Injection Free Interval	Sham and Ranibizumab		29	Inter-Quartile Range 28 to 56	Days
Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25	Dexamethasone and Ranibizumab	Baseline	55.5	Standard Deviation 15.27	Letters
Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25	Sham and Ranibizumab	Baseline	58.1	Standard Deviation 12.64	Letters
Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25	Dexamethasone and Ranibizumab	Change from baseline at week 25	2.0	Standard Deviation 8.61	Letters
Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25	Sham and Ranibizumab	Change from baseline at week 25	2.4	Standard Deviation 9.14	Letters
Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye	Dexamethasone and Ranibizumab	Baseline	260.28	Standard Deviation 123.625	Microns
Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye	Sham and Ranibizumab	Baseline	272.45	Standard Deviation 130.829	Microns
Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye	Dexamethasone and Ranibizumab	Change from baseline at week 25 (n=105, 111)	-7.12	Standard Deviation 77.898	Microns
Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye	Sham and Ranibizumab	Change from baseline at week 25 (n=105, 111)	-13.00	Standard Deviation 97.651	Microns

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Dexamethasone and Ranibizumab	123
Overall Study	STARTED	Sham and Ranibizumab	120
Overall Study	COMPLETED	Dexamethasone and Ranibizumab	115
Overall Study	COMPLETED	Sham and Ranibizumab	115
Overall Study	NOT COMPLETED	Dexamethasone and Ranibizumab	8
Overall Study	NOT COMPLETED	Sham and Ranibizumab	5

Source ClinicalTrials.gov

Adverse events82

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	Dexamethasone and Ranibizumab	23	121
other	Conjunctival haemorrhage	Eye disorders	Sham and Ranibizumab	12	118
other	Intraocular pressure increased	Eye disorders	Dexamethasone and Ranibizumab	16	121
other	Intraocular pressure increased	Eye disorders	Sham and Ranibizumab	5	118
other	Retinal haemorrhage	Eye disorders	Dexamethasone and Ranibizumab	9	121
other	Retinal haemorrhage	Eye disorders	Sham and Ranibizumab	7	118
other	Visual acuity reduced	Eye disorders	Dexamethasone and Ranibizumab	9	121
other	Visual acuity reduced	Eye disorders	Sham and Ranibizumab	5	118
other	Macular degeneration	Eye disorders	Dexamethasone and Ranibizumab	6	121
other	Macular degeneration	Eye disorders	Sham and Ranibizumab	5	118

1 to 10 of 82Source ClinicalTrials.gov

See all 82 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dexamethasone and Ranibizumab
Total, all-cause mortality	Sham and Ranibizumab
Total, other adverse events	Dexamethasone and Ranibizumab	86	121
Total, other adverse events	Sham and Ranibizumab	59	118
Total, serious adverse events	Dexamethasone and Ranibizumab	9	121
Total, serious adverse events	Sham and Ranibizumab	14	118

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26088793	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
Dexamethasone and Ranibizumab vs Sham and 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/NCT00511706

GET https://conductscience.org/api/trials/v1/NCT00511706/events?page=2

API reference For AI assistants