Trial Outcomes & Findings for Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema (NCT NCT01571232)

Results Overview

The measure the change in ETDRS letters for each treatment group from baseline to 6 months.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

6 months

Results posted on

2021-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	Ozurdex Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)	Avastin Patients in this group receive Avastin Q1 month for 5 months. intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
Overall Study STARTED	10	10
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ozurdex Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)	Avastin Patients in this group receive Avastin Q1 month for 5 months. intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Ozurdex for Treatment of Recalcitrant Diabetic Macular Edema

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ozurdex n=10 Participants Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)	Avastin n=10 Participants Patients in this group receive Avastin Q1 month for 5 months. intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.	Total n=20 Participants Total of all reporting groups
Age, Continuous	63.9 years STANDARD_DEVIATION 1.8 • n=5 Participants	61.2 years STANDARD_DEVIATION 2.9 • n=7 Participants	62.6 years STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

The measure the change in ETDRS letters for each treatment group from baseline to 6 months.

Outcome measures

Outcome measures
Measure	Ozurdex n=9 Participants Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)	Avastin n=10 Participants Patients in this group receive Avastin Q1 month for 5 months. intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
The Change in Visual Acuity (Number of ETDRS Letters). Baseline	67.8 ETDRS letters Standard Error 3.8	71.9 ETDRS letters Standard Error 2.9
The Change in Visual Acuity (Number of ETDRS Letters). Final Visit	69.6 ETDRS letters Standard Error 4.8	72.9 ETDRS letters Standard Error 3.4

PRIMARY outcome

Timeframe: 6 months

The measure the change in central foveal thickness for each treatment group from baseline to 6 months.

Outcome measures

Outcome measures
Measure	Ozurdex n=9 Participants Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)	Avastin n=10 Participants Patients in this group receive Avastin Q1 month for 5 months. intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
The Change in Central Foveal Thickness (Microns on High Resolution OCT). Baseline	385.9 microns Standard Error 43.0	341.5 microns Standard Error 11.3
The Change in Central Foveal Thickness (Microns on High Resolution OCT). Final Visit	305.4 microns Standard Error 9.1	324.3 microns Standard Error 10.9

SECONDARY outcome

Timeframe: 6 months

Population: Fluorescein angiography data were not collected.

To qualitatively assess the change in macular leakage on fluorescein angiography from baseline to 6 months for each treatment arm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: One patient in the Ozurdex group withdrew consent, one patient in the Avastin group was lost to follow-up, and results were unattainable for two patients due to imaging difficulties.

To assess the change in macular sensitivity on microperimetry from baseline to 6 months for each treatment arm.

Outcome measures

Outcome measures
Measure	Ozurdex n=8 Participants Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)	Avastin n=8 Participants Patients in this group receive Avastin Q1 month for 5 months. intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
The Change in Mean Macular Sensitivity on Microperimetry From Baseline Baseline	5.6 dB Standard Error 2.0	10.7 dB Standard Error 2.2
The Change in Mean Macular Sensitivity on Microperimetry From Baseline Final Visit	7.4 dB Standard Error 1.2	10.7 dB Standard Error 1.5

SECONDARY outcome

Timeframe: 6 months

Population: One patient in the Ozurdex group withdrew consent, one patient in the Avastin group was lost to follow-up, and results were unattainable for three other patients due to testing difficulties.

To assess the change in mean central amplitude on multi-focal ERG from baseline to 6 months for each treatment arm.

Outcome measures

Outcome measures
Measure	Ozurdex n=8 Participants Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)	Avastin n=7 Participants Patients in this group receive Avastin Q1 month for 5 months. intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
The Change in Mean Central Amplitude on Multi-focal ERG From Baseline. Baseline	27.8 nV/deg2 Standard Error 4.3	34.4 nV/deg2 Standard Error 11.0
The Change in Mean Central Amplitude on Multi-focal ERG From Baseline. Final Visit	40.9 nV/deg2 Standard Error 3.8	30.3 nV/deg2 Standard Error 6.5

Adverse Events

Ozurdex

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Avastin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ozurdex n=10 participants at risk Patients in this group receive Ozurdex at initial visit and at month 4 dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)	Avastin n=10 participants at risk Patients in this group receive Avastin Q1 month for 5 months. intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
Eye disorders Elevated Intraocular Pressure	10.0% 1/10 • 6 months	0.00% 0/10 • 6 months

Additional Information

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

Retina Macula Institute

Phone: 310-944-9393

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place