NCT00168324 is a Phase 3 clinical trial of 700 µg Dexamethasone in Macular Edema, sponsored by Allergan.

Who is sponsoring NCT00168324?

NCT00168324 is sponsored by Allergan.

What drugs are being tested in NCT00168324?

Interventions in NCT00168324: 700 µg Dexamethasone, 350 µg Dexamethasone, Sham Injection.

What condition does NCT00168324 study?

NCT00168324 studies Macular Edema, Retinal Vein Occlusion.

Is NCT00168324 still recruiting?

NCT00168324 is currently completed. Last updated 23 April 2019.

Are results published for NCT00168324?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-04-23 · How we verify

NCT00168324

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion

Completed Phase 3 Results posted Last updated 23 April 2019

What this trial tests

Phase 3 trial testing 700 µg Dexamethasone in Macular Edema in 599 participants. Completed in 1 October 2008.

Timeline

1 October 2004

Primary endpoint
1 March 2008

1 October 2008

Quick facts

Lead sponsor	Allergan
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	599
Start date	1 October 2004
Primary completion	1 March 2008
Estimated completion	1 October 2008
Sites	13 locations across France, South Africa, Austria, Taiwan, Germany, Israel, Mexico, Philippines

Drugs / interventions tested

700 µg Dexamethasone — full drug profile →
350 µg Dexamethasone — full drug profile →
Sham Injection — full drug profile →

Conditions studied

Macular Edema — all drugs for Macular Edema →
Retinal Vein Occlusion — all drugs for Retinal Vein Occlusion →

Sponsor

Allergan — full company profile →

Who can join

18 and older, any sex, with Macular Edema or Retinal Vein Occlusion. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye Secondary · 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.

Day 90

Group	Value	95% CI
700 µg Dexamethasone	45
350 µg Dexamethasone	41
Sham Injection	25

Day 180

Group	Value	95% CI
700 µg Dexamethasone	39
350 µg Dexamethasone	32
Sham Injection	37

Change From Baseline in Retinal Thickness in the Study Eye Secondary · 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.

Baseline

Group	Value	95% CI
700 µg Dexamethasone	548.9	± 185.45
350 µg Dexamethasone	541.6	± 183.68
Sham Injection	534.4	± 187.38

Change from Baseline at Day 90

Group	Value	95% CI
700 µg Dexamethasone	-199.3	± 194.54
350 µg Dexamethasone	-144.1	± 166.59
Sham Injection	-78.2	± 150.05

Change from Baseline at Day 180

Group	Value	95% CI
700 µg Dexamethasone	-105.0	± 197.83
350 µg Dexamethasone	-91.4	± 198.16
Sham Injection	-110.3	± 175.59

Cumulative Response Rate of 15 or More Letter Improvement Primary · 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.

Day 30

Group	Value	95% CI
700 µg Dexamethasone	0.101
350 µg Dexamethasone	0.092
Sham Injection	0.045

Day 60

Group	Value	95% CI
700 µg Dexamethasone	0.258
350 µg Dexamethasone	0.204
Sham Injection	0.100

Day 90

Group	Value	95% CI
700 µg Dexamethasone	0.359
350 µg Dexamethasone	0.292
Sham Injection	0.165

Day 180

Group	Value	95% CI
700 µg Dexamethasone	0.397
350 µg Dexamethasone	0.349
Sham Injection	0.225

Percentage of Patients With a Change From Baseline in BCVA by Category Secondary · 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.

≥15 Letters Improvement

Group	Value	95% CI
700 µg Dexamethasone	22.4
350 µg Dexamethasone	20.9
Sham Injection	12.4

≥5 and <15 Letters Improvement

Group	Value	95% CI
700 µg Dexamethasone	39.8
350 µg Dexamethasone	42.3
Sham Injection	34.2

No Change (Between -5 to +5 Letters)

Group	Value	95% CI
700 µg Dexamethasone	27.4
350 µg Dexamethasone	23.5
Sham Injection	34.7

≥5 and <15 Letters Worsening

Group	Value	95% CI
700 µg Dexamethasone	7.0
350 µg Dexamethasone	9.2
Sham Injection	13.4

≥15 Letters Worsening

Group	Value	95% CI
700 µg Dexamethasone	3.5
350 µg Dexamethasone	4.1
Sham Injection	5.4

Percentage of Patients With a Change From Baseline in BCVA by Category Secondary · 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.

≥15 Letters Improvement

Group	Value	95% CI
700 µg Dexamethasone	19.4
350 µg Dexamethasone	16.3
Sham Injection	18.3

≥5 and <15 Letters Improvement

Group	Value	95% CI
700 µg Dexamethasone	34.8
350 µg Dexamethasone	37.8
Sham Injection	27.7

No Change (Between -5 to +5 Letters)

Group	Value	95% CI
700 µg Dexamethasone	29.4
350 µg Dexamethasone	25.5
Sham Injection	30.2

≥5 and <15 Letters Worsening

Group	Value	95% CI
700 µg Dexamethasone	10.9
350 µg Dexamethasone	10.7
Sham Injection	14.9

≥15 Letters Worsening

Group	Value	95% CI
700 µg Dexamethasone	5.5
350 µg Dexamethasone	9.7
Sham Injection	8.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events (AEs) and Serious Adverse Events (SAEs) are reported for the double-blind treatment period through Month 6.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

700 µg Dexamethasone

Serious: 12/196 (6%)

Deaths: —

350 µg Dexamethasone

Serious: 28/197 (14%)

Deaths: —

Sham Injection

Serious: 14/202 (7%)

Deaths: —

Serious adverse events (39 terms)

Reaction	System	700 µg Dexamethasone	350 µg Dexamethasone	Sham Injection
Myocardial infarction	Cardiac disorders	—	—	—
Intraocular pressure increased	Investigations	—	—	—
Angina pectoris	Cardiac disorders	—	—	—
Arrhythmia	Cardiac disorders	—	—	—
Syncope	Nervous system disorders	—	—	—
Transient ischaemic attack	Nervous system disorders	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—
Carotid artery stenosis	Nervous system disorders	—	—	—
Mental status changes	Psychiatric disorders	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Glaucoma	Eye disorders	—	—	—
Benign prostatic hyperplasia	Reproductive system and breast disorders	—	—	—
Blindness	Eye disorders	—	—	—
Cardiogenic shock	Cardiac disorders	—	—	—
Convulsion	Nervous system disorders	—	—	—
Drowning	General disorders	—	—	—
Gastroenteritis	Infections and infestations	—	—	—
Humerus fracture	Injury, poisoning and procedural complications	—	—	—
Hypotension	Vascular disorders	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—
Pneumonia	Infections and infestations	—	—	—
Pneumonia viral	Infections and infestations	—	—	—

Other adverse events (5 terms — click to expand)

Reaction	System	700 µg Dexamethasone	350 µg Dexamethasone	Sham Injection
Intraocular pressure increased	Investigations	—	—	—
Conjunctival haemorrhage	Eye disorders	—	—	—
Maculopathy	Eye disorders	—	—	—
Eye pain	Eye disorders	—	—	—
Conjunctival hyperaemia	Eye disorders	—	—	—

Most-reported serious reactions: Myocardial infarction, Intraocular pressure increased, Angina pectoris, Arrhythmia, Syncope, Transient ischaemic attack, Cerebrovascular accident, Carotid artery stenosis.

Data from ClinicalTrials.gov NCT00168324 adverse events section.

Sponsor's own description

This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of macular edema associated with retinal vein occlusion.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Intravitreal steroids versus observation for macular edema secondary to central retinal vein occlusion.
Gewaily D, Muthuswamy K, Greenberg PB. · · 2015 · cited 7× · PMID 26352007 · DOI 10.1002/14651858.cd007324.pub3

Verify or expand the search:

Other trials of 700 µg Dexamethasone

Trials testing the same drug.

NCT00168298 — A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion · Phase 3 · completed

Other recruiting trials for Macular Edema

Currently open trials in the same condition.

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Other Allergan trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00168324 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Allergan
Last refreshed: 23 April 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00168324.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT00168324

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (39 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of 700 µg Dexamethasone

Other recruiting trials for Macular Edema

Other Allergan trials

Verify against primary sources