Trial Outcomes & Findings for Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections. (NCT NCT01449682)

NCT ID: NCT01449682

Last Updated: 2017-05-31

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 10 participants
• Primary outcome timeframe: baseline to 48 weeks
• Results posted on: 2017-05-31

Participant Flow

Participant milestones

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

Reasons for withdrawal

Measure	Active Comparator: Ozurdex PRN Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and PRN every 16 weeks Other Name: Ozurdex PRN	Active Comparator: Ozurdex q16 Weeks Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and every 16 weeks Other Name: Ozurdex q16 weeks
Overall Study Death	0	1
Overall Study Adverse Event	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Ozurdex PRN n=5 Participants Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and PRN every 16 weeks Other Name: Ozurdex PRN	Ozurdex q16 Weeks n=5 Participants Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and every 16 weeks Other Name: Ozurdex PRN	Total n=10 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	69.1 years STANDARD_DEVIATION 5.7 • n=5 Participants	63.3 years STANDARD_DEVIATION 8.0 • n=7 Participants	66.2 years STANDARD_DEVIATION 4.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Ozurdex PRN n=5 Participants 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	Ozurdex Q16 Weeks n=5 Participants 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
Macular Function Using Microperimetry Baseline	2.7 dB Standard Error 0.8	12.7 dB Standard Error 2.6
Macular Function Using Microperimetry Final Visit	4.2 dB Standard Error 1.7	10.7 dB Standard Error 1.9

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Ozurdex PRN n=5 Participants 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	Ozurdex Q16 Weeks n=5 Participants 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
Macular Function Using Multi-focal ERG Baseline	3.61 nV/deg2 Standard Error 0.39	6.62 nV/deg2 Standard Error 0.83
Macular Function Using Multi-focal ERG Final Visit	18.20 nV/deg2 Standard Error 4.03	30.18 nV/deg2 Standard Error 9.60

SECONDARY outcome

Timeframe: baseline to 48 weeks

Outcome measures

Measure	Ozurdex PRN n=5 Participants 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	Ozurdex Q16 Weeks n=5 Participants 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
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	46.4 ETDRS letters Standard Error 7.1	55.6 ETDRS letters Standard Error 7.5
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 Final Visit	27.8 ETDRS letters Standard Error 8.4	53.2 ETDRS letters Standard Error 8.5

SECONDARY outcome

Timeframe: baseline to 48 weeks

Outcome measures

Measure	Ozurdex PRN n=5 Participants 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	Ozurdex Q16 Weeks n=5 Participants 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
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	501.7 microns Standard Error 59.7	353.5 microns Standard Error 27.0
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 Final Visit	361.4 microns Standard Error 47.3	326.7 microns Standard Error 21.2

Adverse Events

Ozurdex PRN

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Ozurdex Q16 Weeks

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Measure	Ozurdex PRN n=5 participants at risk 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	Ozurdex Q16 Weeks n=5 participants at risk 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
Eye disorders Cataract Requiring Emergent Surgery	20.0% 1/5 • Number of events 1	0.00% 0/5

Other adverse events

Measure	Ozurdex PRN n=5 participants at risk 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	Ozurdex Q16 Weeks n=5 participants at risk 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
Eye disorders Elevated Intraocular Pressure	0.00% 0/5	20.0% 1/5 • Number of events 1

Additional Information

Ron P. Gallemore, M.D., Ph. D.

Retina Macula Institute

Phone: 310) 944-9393

Email: rongallemoremd@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place