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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01660802
• Collaborator: (none)
• Enrollment: 262
• Location: 1
• Arms: 2
• Actual Duration (Months): 20.5
• Patients Per Site Per Month: 12.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Edema	Drug: 700 μg Dexamethasone; Other: Sham	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 262 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Actual Study Start Date: Sep 4, 2012
• Actual Primary Completion Date: Mar 31, 2014
• Actual Study Completion Date: May 20, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 700 μg Dexamethasone 700 μg Dexamethasone intravitreal injection in the study eye on Day 1.	Drug: 700 μg Dexamethasone; 700 μg Dexamethasone intravitreal injection in the study eye on Day 1.; Other Names: Ozurdex®
Sham Comparator: Sham Sham administered in the study eye on Day 1.	Drug: 700 μg Dexamethasone; 700 μg Dexamethasone intravitreal injection in the study eye on Day 1.; Other Names: Ozurdex® ; Other: Sham; Sham administered in the study eye on Day 1.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. Average Change From Baseline in BCVA in the Study Eye [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.

2. Change From Baseline in BCVA in the Study Eye [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.

3. Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

-Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)

Exclusion Criteria:

• History of glaucoma, ocular hypertension or optic nerve head change

• Any active bacterial, viral, parasitic, or fungal infections in either eye

• Eye surgery, including cataract surgery, and/or laser of any type in the study eye within 3 months prior to study start

• History of use of intravitreal steroids or any intravitreal injectable drug in the study eye within 3 months prior to study start

• Use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal steroids within 1 month prior to study start

• Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to study start

• Use of topical ophthalmic corticosticosteroids within 2 weeks of study start

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Beijing		China

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

• Li X, Wang N, Liang X, Xu G, Li XY, Jiao J, Lou J, Hashad Y; China Ozurdex in RVO Study Group. 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. Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):59-69. doi: 10.1007/s00417-017-3831-6. Epub 2017 Nov 8.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01660802
• Other Study ID Numbers: 206207-020
• First Posted: Aug 9, 2012
• Last Update Posted: Apr 17, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Macular Edema; Edema; Dexamethasone

Study Results

Participant Flow

Arm/Group Title	700 μg Dexamethasone	Sham
Arm/Group Description	700 μg Dexamethasone intravitreal injection in the study eye on Day 1.	Sham administered in the study eye on Day 1.
Period Title: Overall Study
STARTED	130	132
COMPLETED	126	121
NOT COMPLETED	4	11

Baseline Characteristics

Arm/Group Title	700 μg Dexamethasone	Sham	Total
Arm/Group Description	700 μg Dexamethasone intravitreal injection in the study eye on Day 1.	Sham administered in the study eye on Day 1.	Total of all reporting groups
Overall Participants	130	132	262
Age, Customized (Number) [Number]
<45 years	18 13.8%	25 18.9%	43 16.4%
45 to 65 years	94 72.3%	86 65.2%	180 68.7%
> 65 years	18 13.8%	21 15.9%	39 14.9%
Sex: Female, Male (Count of Participants)
Female	60 46.2%	76 57.6%	136 51.9%
Male	70 53.8%	56 42.4%	126 48.1%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
Description	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.
Time Frame	Baseline, 6 Months

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat: all randomized and treated patients

Arm/Group Title	700 μg Dexamethasone	Sham
Arm/Group Description	700 μg Dexamethasone intravitreal injection in the study eye on Day 1.	Sham administered in the study eye on Day 1.
Measure Participants	129	130
Number [Patients]	60	31

2. Secondary Outcome

Title	Average Change From Baseline in BCVA in the Study Eye
Description	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.
Time Frame	Baseline, 6 Months

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat: all randomized and treated patients

Arm/Group Title	700 μg Dexamethasone	Sham
Arm/Group Description	700 μg Dexamethasone intravitreal injection in the study eye on Day 1.	Sham administered in the study eye on Day 1.
Measure Participants	129	130
Baseline	52.6 (10.79)	53.1 (10.47)
Average Change from Baseline Over 6 Months	6.6 (8.98)	2.5 (9.98)

3. Secondary Outcome

Title	Change From Baseline in BCVA in the Study Eye
Description	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.
Time Frame	Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat: all randomized and treated patients

Arm/Group Title	700 μg Dexamethasone	Sham
Arm/Group Description	700 μg Dexamethasone intravitreal injection in the study eye on Day 1.	Sham administered in the study eye on Day 1.
Measure Participants	129	130
Baseline	52.6 (10.79)	53.1 (10.47)
Change from Baseline at Month 1	9.1 (8.45)	2.0 (9.28)
Change from Baseline at Month 2	10.6 (10.36)	1.7 (12.29)
Change from Baseline at Month 3	7.7 (12.66)	1.8 (12.98)
Change from Baseline at Month 4	5.2 (12.79)	3.3 (12.32)
Change from Baseline at Month 5	4.4 (13.28)	3.3 (13.04)
Change from Baseline at Month 6	3.2 (15.34)	4.0 (13.73)

4. Secondary Outcome

Title	Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye
Description	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.
Time Frame	Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

Outcome Measure Data

Analysis Population Description

Modified Intent-to-Treat: all randomized and treated patients

Arm/Group Title	700 μg Dexamethasone	Sham
Arm/Group Description	700 μg Dexamethasone intravitreal injection in the study eye on Day 1.	Sham administered in the study eye on Day 1.
Measure Participants	129	130
Month 1	28.7	5.4
Month 2	34.9	11.5
Month 3	33.3	13.1
Month 4	23.3	14.6
Month 5	22.5	22.3
Month 6	23.3	20.8

Adverse Events

Adverse Event Reporting Description	The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs). Treatment emergent adverse events (TEAE) are reported and include all AEs and SAEs that began or worsened after study treatment.
Arm/Group Title	700 μg Dexamethasone		Sham
Arm/Group Description	700 μg Dexamethasone intravitreal injection in the study eye on Day 1.		Sham administered in the study eye on Day 1.
All Cause Mortality
	700 μg Dexamethasone		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	700 μg Dexamethasone		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/129 (0.8%)		2/130 (1.5%)
Cardiac disorders
Atrioventricular Block	1/129 (0.8%)		0/130 (0%)
Eye disorders
Vitreous Haemorrhage	0/129 (0%)		1/130 (0.8%)
Hepatobiliary disorders
Cholecystitis Chronic	0/129 (0%)		1/130 (0.8%)
Other (Not Including Serious) Adverse Events
	700 μg Dexamethasone		Sham
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	69/129 (53.5%)		15/130 (11.5%)
Eye disorders
Conjunctival Haemorrhage	24/129 (18.6%)		5/130 (3.8%)
Conjunctival Hyperaemia	17/129 (13.2%)		6/130 (4.6%)
Investigations
Intraocular Pressure Increased	38/129 (29.5%)		4/130 (3.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for at least 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.