NCT01660802

Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)

Completed Phase 3 Results posted Last updated 17 April 2019

What this trial tests

Phase 3 trial testing 700 μg Dexamethasone in Macular Edema in 262 participants. Completed in 20 May 2014.

Timeline

4 September 2012

Primary endpoint
31 March 2014

20 May 2014

Quick facts

Lead sponsor	Allergan
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	262
Start date	4 September 2012
Primary completion	31 March 2014
Estimated completion	20 May 2014
Sites	1 location across China

Drugs / interventions tested

• 700 μg Dexamethasone
• Sham

Conditions studied

• Macular Edema — all drugs for Macular Edema →

Sponsor

Allergan — full company profile →

Who can join

Adults 18 to 99, any sex, with Macular Edema. 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 · Baseline, 6 Months

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	60
Sham	31

Average Change From Baseline in BCVA in the Study Eye Secondary · Baseline, 6 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.

Baseline

Group	Value	95% CI
700 μg Dexamethasone	52.6	± 10.79
Sham	53.1	± 10.47

Average Change from Baseline Over 6 Months

Group	Value	95% CI
700 μg Dexamethasone	6.6	± 8.98
Sham	2.5	± 9.98

Change From Baseline in BCVA in the Study Eye Secondary · Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

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. A decrease in the number of letters read correctly (negative number) means that vision has worsened.

Baseline

Group	Value	95% CI
700 μg Dexamethasone	52.6	± 10.79
Sham	53.1	± 10.47

Change from Baseline at Month 1

Group	Value	95% CI
700 μg Dexamethasone	9.1	± 8.45
Sham	2.0	± 9.28

Change from Baseline at Month 2

Group	Value	95% CI
700 μg Dexamethasone	10.6	± 10.36
Sham	1.7	± 12.29

Change from Baseline at Month 3

Group	Value	95% CI
700 μg Dexamethasone	7.7	± 12.66
Sham	1.8	± 12.98

Change from Baseline at Month 4

Group	Value	95% CI
700 μg Dexamethasone	5.2	± 12.79
Sham	3.3	± 12.32

Change from Baseline at Month 5

Group	Value	95% CI
700 μg Dexamethasone	4.4	± 13.28
Sham	3.3	± 13.04

Change from Baseline at Month 6

Group	Value	95% CI
700 μg Dexamethasone	3.2	± 15.34
Sham	4.0	± 13.73

Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye Secondary · Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

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 indicates improvement and a decrease in the number of letters read correctly indicates a worsening.

Month 1

Group	Value	95% CI
700 μg Dexamethasone	28.7
Sham	5.4

Month 2

Group	Value	95% CI
700 μg Dexamethasone	34.9
Sham	11.5

Month 3

Group	Value	95% CI
700 μg Dexamethasone	33.3
Sham	13.1

Month 4

Group	Value	95% CI
700 μg Dexamethasone	23.3
Sham	14.6

Month 5

Group	Value	95% CI
700 μg Dexamethasone	22.5
Sham	22.3

Month 6

Group	Value	95% CI
700 μg Dexamethasone	23.3
Sham	20.8

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

700 μg Dexamethasone

Serious: 1/129 (1%)

Deaths: —

Sham

Serious: 2/130 (2%)

Deaths: —

Serious adverse events (3 terms)

Reaction	System	700 μg Dexamethasone	Sham
Atrioventricular Block	Cardiac disorders	—	—
Cholecystitis Chronic	Hepatobiliary disorders	—	—
Vitreous Haemorrhage	Eye disorders	—	—

Other adverse events (3 terms — click to expand)

Reaction	System	700 μg Dexamethasone	Sham
Intraocular Pressure Increased	Investigations	—	—
Conjunctival Haemorrhage	Eye disorders	—	—
Conjunctival Hyperaemia	Eye disorders	—	—

Most-reported serious reactions: Atrioventricular Block, Cholecystitis Chronic, Vitreous Haemorrhage.

Data from ClinicalTrials.gov NCT01660802 adverse events section.

Sponsor's own description

This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety and efficacy of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in Chinese patients: randomized, sham-controlled, multicenter study.
   Li X, Wang N, Liang X, Xu G, et al · · 2018 · cited 40× · PMID 29119239 · DOI 10.1007/s00417-017-3831-6
2. Treatment patterns of ranibizumab intravitreal injection and dexamethasone intravitreal implant for retinal vein occlusion in the USA.
   Nghiem-Buffet S, Baillif S, Regnier S, Skelly A, et al · · 2017 · cited 9× · PMID 27911446 · DOI 10.1038/eye.2016.269
3. 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