NCT00168298 is a Phase 3 clinical trial of 700 µg Dexamethasone in Macular Edema, sponsored by Allergan.

Who is sponsoring NCT00168298?

NCT00168298 is sponsored by Allergan.

What drugs are being tested in NCT00168298?

Interventions in NCT00168298: 700 µg Dexamethasone, 350 µg Dexamethasone, Sham Injection.

What condition does NCT00168298 study?

NCT00168298 studies Macular Edema, Retinal Vein Occlusion.

Is NCT00168298 still recruiting?

NCT00168298 is currently completed. Last updated 23 April 2019.

Are results published for NCT00168298?

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

NCT00168298

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 668 participants. Completed in 5 September 2008.

Timeline

1 November 2004

Primary endpoint
1 March 2008

5 September 2008

Quick facts

Lead sponsor	Allergan
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	668
Start date	1 November 2004
Primary completion	1 March 2008
Estimated completion	5 September 2008
Sites	13 locations across Hong Kong, Colombia, Italy, New Zealand, United Kingdom, Poland, South Korea, Canada

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 Primary · 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 are presented.

Group	Value	95% CI
700 µg Dexamethasone	53
350 µg Dexamethasone	48
Sham Injection	38

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	573.6	± 189.08
350 µg Dexamethasone	566.6	± 219.63
Sham Injection	542.5	± 185.64

Change from Baseline at Day 90

Group	Value	95% CI
700 µg Dexamethasone	-215.6	± 207.62
350 µg Dexamethasone	-205.5	± 216.25
Sham Injection	-91.1	± 191.85

Change from Baseline at Day 180

Group	Value	95% CI
700 µg Dexamethasone	-132.1	± 207.20
350 µg Dexamethasone	-150.5	± 220.78
Sham Injection	-127.4	± 197.77

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	21.2
350 µg Dexamethasone	25.7
Sham Injection	13.8

≥5 and <15 Letters Improvement

Group	Value	95% CI
700 µg Dexamethasone	45.1
350 µg Dexamethasone	39.0
Sham Injection	37.1

No Change (Between -5 to +5 Letters)

Group	Value	95% CI
700 µg Dexamethasone	25.7
350 µg Dexamethasone	26.6
Sham Injection	29.9

≥5 and <15 Letters Worsening

Group	Value	95% CI
700 µg Dexamethasone	4.4
350 µg Dexamethasone	6.4
Sham Injection	11.2

≥15 Letters Worsening

Group	Value	95% CI
700 µg Dexamethasone	3.5
350 µg Dexamethasone	2.3
Sham Injection	8.0

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	23.5
350 µg Dexamethasone	21.6
Sham Injection	17.0

≥5 and <15 Letters Improvement

Group	Value	95% CI
700 µg Dexamethasone	35.0
350 µg Dexamethasone	33.9
Sham Injection	28.6

No Change (Between -5 to +5 Letters)

Group	Value	95% CI
700 µg Dexamethasone	27.0
350 µg Dexamethasone	28.9
Sham Injection	28.6

≥5 and <15 Letters Worsening

Group	Value	95% CI
700 µg Dexamethasone	8.0
350 µg Dexamethasone	10.6
Sham Injection	13.8

≥15 Letters Worsening

Group	Value	95% CI
700 µg Dexamethasone	6.6
350 µg Dexamethasone	5.0
Sham Injection	12.1

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: 16/225 (7%)

Deaths: —

350 µg Dexamethasone

Serious: 7/215 (3%)

Deaths: —

Sham Injection

Serious: 17/221 (8%)

Deaths: —

Serious adverse events (35 terms)

Reaction	System	700 µg Dexamethasone	350 µg Dexamethasone	Sham Injection
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—
Cardiac failure congestive	Cardiac disorders	—	—	—
Renal failure acute	Renal and urinary disorders	—	—	—
Aneurysmal bone cyst	Musculoskeletal and connective tissue disorders	—	—	—
Aortic aneurysm	Vascular disorders	—	—	—
Cardiac arrest	Cardiac disorders	—	—	—
Carotid artery occlusion	Nervous system disorders	—	—	—
Cerebellar infarction	Nervous system disorders	—	—	—
Cholecystitis	Hepatobiliary disorders	—	—	—
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	—	—	—
Intraocular pressure increased	Investigations	—	—	—
Non-cardiac chest pain	General disorders	—	—	—
Ocular hypertension	Eye disorders	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—
Cerebrovascular accident	Nervous system disorders	—	—	—
Angina pectoris	Cardiac disorders	—	—	—
Atrial septal defect	Congenital, familial and genetic disorders	—	—	—
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Parkinson's disease	Nervous system disorders	—	—	—
Angina unstable	Cardiac disorders	—	—	—
Appendicitis	Infections and infestations	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Cellulitis	Infections and infestations	—	—	—

Other adverse events (7 terms — click to expand)

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

Most-reported serious reactions: Breast cancer, Myocardial infarction, Cardiac failure congestive, Renal failure acute, Aneurysmal bone cyst, Aortic aneurysm, Cardiac arrest, Carotid artery occlusion.

Data from ClinicalTrials.gov NCT00168298 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.

NCT00168324 — 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.

NCT06962839 — A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema · Phase 2 · recruiting
NCT06686641 — Incidence of Macular Edema in a Uveitis Population · active not recruiting
NCT05976139 — Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies · NA · recruiting
NCT05698329 — Effect of AIV007 by Periocular Administration in Subjects with Macular Edema Secondary to Neovascular Age-related Macula · Phase 1 · active not recruiting
NCT06595355 — Efficacy and Safety of Intravitreal Injection of Bevacizumab with and Without Oral Curcumin · Phase 2, PHASE3 · recruiting

Other Allergan trials

Trials by the same sponsor.

NCT04609020 — Study to Evaluate Subject Satisfaction With Facial Appearance and Impact of Combined Facial Treatment · Phase 4 · completed
NCT05452070 — A Study to Assess Adverse Events and Change in Disease Activity of HArmonyCa Lidocaine Injectable Gel for Mid Face Soft · Phase 3 · completed
NCT05393089 — Study of AGN-190584 Eye Drops to Assess Safety and Efficacy in Participants Aged 40-80 Years With Pseudophakic Presbyopi · Phase 2 · withdrawn
NCT05152576 — A Study To Assess the Adverse Effects and Change in Condition of OnabotulinumtoxinA X Injection in Adult Participants Wi · Phase 2 · completed
NCT05088980 — Study to Assess Effectiveness and Adverse Events of JUVEDERM VOLBELLA With Lidocaine Injection in Correcting Infraorbita · Phase 3 · completed

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 NCT00168298 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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/NCT00168298.

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

NCT00168298

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 (35 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