Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections.

• Sponsor: Retina Macula Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01449682
• Collaborator: Allergan (Industry)
• Enrollment: 10
• Location: 1
• Arms: 2
• Duration (Months): 16.1
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

To test the efficacy of a 0.7 mg intravitreal dexamethasone implant (Ozurdex®) on macular function and recalcitrant macular edema associated with retinal vein occlusion following treatment with 2 or more prior intravitreal anti-VEGF drug injections.

Condition or Disease	Intervention/Treatment	Phase
Retinal Vein Occlusion; Macular Edema	Drug: Ozurdex; Drug: Ozurdex	Phase 3

Detailed Description

The efficacy of the DEX implant on macular edema for RVO is well established in multiple clinical trials. However, the duration and frequency of re-treatment have not been extensively explored. In addition, no prior studies have tested the efficacy of the DEX implant on retinal and macular function using diagnostic testing measurements such as multi-focal ERG, microperimetry and RAM testing. Since VA and OCT outcomes do not always correlate, these other assessments (mf-ERG, microperimetry, RAM testing) may be useful as early predictors of when or if patients should be retreated. This study will assess 2 groups (0.7mg PRN and 0.7mg Q16 weeks) and assess high resolution OCT, RAM testing, microperimetry, and Multi-focal ERG outcomes. For the PRN group retreated based on any fluid on OCT, we will investigate if microperimetry or multifocal ERG changes would have been an earlier predictor of fluid returning.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy of an Intravitreal Dexamethasone Implant on Macular Function in Retinal Vein Occlusion Following Treatment With Intravitreal Anti-VEGF Injections.
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ozurdex PRN 0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT	Drug: Ozurdex; 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies; Other Names: Dexamethasone implant, DEX implant
Active Comparator: Ozurdex Q16 weeks 0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks	Drug: Ozurdex; 0.7 mg intravitreal DEX implant on first visit then every 16 weeks; Other Names: dexamethasone implant, DEX implant

Outcome Measures

Primary Outcome Measures

1. Macular Function Using Microperimetry [baseline to 48 weeks]

   To determine if there is change in mean macular sensitivity using microperimetry at 48 weeks compared to baseline for both the PRN and Q16weeks treatment groups

2. Macular Function Using Multi-focal ERG [baseline to 48 weeks]

   To determine if there is a change in central amplitude responses using multifocal ERG at 48 weeks compared to baseline values for both the PRN and Q16weeks treatment groups

Secondary Outcome Measures

1. To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups [baseline to 48 weeks]

2. To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups [baseline to 48 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Presence of central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO)

• Prior treatment with >= 2 intravitreal anti-VEGF injections but no treatment in last 45 days.

• Age 18 years or older

• ETDRS Visual acuity between 3 and 72 letters and approximate Snellen equivalent of 20/25 to 20/800

• Central foveal thickness >275 microns or presence of cystic edema on OCT studies.

• For sexually active women of childbearing potential, agreement to the use of an appropriate form of contraception (or abstinence) for the duration of the study.

• Ability to provide written informed consent • Capable of complying with study protocol

Exclusion Criteria:

• History of steroid-related glaucoma (steroid response) requiring more than one topical glaucoma medication.

• Intraocular injection of steroid medication within prior 4 months

• Evidence of significant retinal ischemia on fluorescein angiography in the opinion of the treating physician.

• Previous laser photocoagulation within 4 months of study

• Concurrent ocular disease (e.g proliferative diabetic retinopathy, geographic atrophy) that would limit visual acuity in the opinion of the treating physician

• Patients who are pregnant.

• Unwilling or unable to follow or comply with all study related procedures.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina Macula Institute	Torrance	California	United States	90503

Sponsors and Collaborators

• Retina Macula Institute
• Allergan

Investigators

• Principal Investigator: Ron P Gallemore, M.D. Ph.D, Retina Macula Institute
• Study Director: Behnam Sharareh, B.S, Retina Macula Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Retina Macula Institute
• ClinicalTrials.gov Identifier: NCT01449682
• Other Study ID Numbers: IIT-287
• First Posted: Oct 10, 2011
• Last Update Posted: May 31, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Retina Macula Institute: BRVO; CRVO; Macular Edema; Anti-VEGF; Ozurdex
• Additional relevant MeSH terms: Macular Edema; Retinal Vein Occlusion; Dexamethasone; Dexamethasone acetate; BB 1101

Study Results

Participant Flow

Arm/Group Title	Active Comparator: Ozurdex PRN	Active Comparator: Ozurdex q16 Weeks
Arm/Group Description	Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and PRN every 16 weeks Other Name: Ozurdex PRN	Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and every 16 weeks Other Name: Ozurdex q16 weeks
Period Title: Overall Study
STARTED	5	5
COMPLETED	4	4
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Ozurdex PRN	Ozurdex q16 Weeks	Total
Arm/Group Description	Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and PRN every 16 weeks Other Name: Ozurdex PRN	Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and every 16 weeks Other Name: Ozurdex PRN	Total of all reporting groups
Overall Participants	5	5	10
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	3 60%	2 40%	5 50%
>=65 years	2 40%	3 60%	5 50%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	69.1 (5.7)	63.3 (8.0)	66.2 (4.7)
Sex: Female, Male (Count of Participants)
Female	2 40%	1 20%	3 30%
Male	3 60%	4 80%	7 70%
Region of Enrollment (participants) [Number]
United States	5 100%	5 100%	10 100%

Outcome Measures

1. Primary Outcome

Title	Macular Function Using Microperimetry
Description	To determine if there is change in mean macular sensitivity using microperimetry at 48 weeks compared to baseline for both the PRN and Q16weeks treatment groups
Time Frame	baseline to 48 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ozurdex PRN	Ozurdex Q16 Weeks
Arm/Group Description	0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies	0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks
Measure Participants	5	5
Baseline	2.7 (0.8)	12.7 (2.6)
Final Visit	4.2 (1.7)	10.7 (1.9)

2. Primary Outcome

Title	Macular Function Using Multi-focal ERG
Description	To determine if there is a change in central amplitude responses using multifocal ERG at 48 weeks compared to baseline values for both the PRN and Q16weeks treatment groups
Time Frame	baseline to 48 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ozurdex PRN	Ozurdex Q16 Weeks
Arm/Group Description	0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies	0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks
Measure Participants	5	5
Baseline	3.61 (0.39)	6.62 (0.83)
Final Visit	18.20 (4.03)	30.18 (9.60)

3. Secondary Outcome

Title	To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups
Time Frame	baseline to 48 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ozurdex PRN	Ozurdex Q16 Weeks
Arm/Group Description	0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies	0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks
Measure Participants	5	5
Baseline	46.4 (7.1)	55.6 (7.5)
Final Visit	27.8 (8.4)	53.2 (8.5)

4. Secondary Outcome

Title	To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups
Time Frame	baseline to 48 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ozurdex PRN	Ozurdex Q16 Weeks
Arm/Group Description	0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies	0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks
Measure Participants	5	5
Baseline	501.7 (59.7)	353.5 (27.0)
Final Visit	361.4 (47.3)	326.7 (21.2)

Adverse Events

Arm/Group Title	Ozurdex PRN		Ozurdex Q16 Weeks
Arm/Group Description	0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies		0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks
All Cause Mortality
	Ozurdex PRN		Ozurdex Q16 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		1/5 (20%)
Serious Adverse Events
	Ozurdex PRN		Ozurdex Q16 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/5 (20%)		0/5 (0%)
Eye disorders
Cataract Requiring Emergent Surgery	1/5 (20%)	1	0/5 (0%)	0
Other (Not Including Serious) Adverse Events
	Ozurdex PRN		Ozurdex Q16 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		1/5 (20%)
Eye disorders
Elevated Intraocular Pressure	0/5 (0%)	0	1/5 (20%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.