Trial Outcomes & Findings for Safety and Effectiveness of Ozurdex Steroid Implants for DME After Vitrectomy Surgery (NCT NCT01788475)

NCT ID: NCT01788475

Last Updated: 2020-03-12

Results Overview

Measured visual acuity gain in number of letters improved as a result of treatment

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

13 months

Results posted on

2020-03-12

Participant Flow

Participant milestones

Participant milestones
Measure	Dexamethasone Implant up to Every 3 Mo. Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter. Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Re-implantation of Ozurdex (dexamethasone) may occur at any time \> 3 months following last injection in group 1 if any of the following conditions are met: 1. Increase of \> 50 microns from the best previous CRT measurement 2. Recurrence of intraretinal cystic edema 3. Persistent intraretinal cystic edema Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant	Dexamethasone Implant up to Every 6 Mo. Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter. Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Re-implantation of Ozurdex (dexamethasone) may occur at any time \>6 months following last injection in group 2 if any of the following conditions are met: 1. Increase of \> 50 microns from the best previous CRT measurement 2. Recurrence of intraretinal cystic edema 3. Persistent intraretinal cystic edema Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant	Sham Implant Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter. Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Also, at 13 months, patients in the sham group will be eligible for Ozurdex (dexamethasone) 0.7 mg implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2. Sham implantation may occur at any time \> 6 months following last sham injection in group 3 if any of the following conditions are met: 1. Increase of \> 50 microns from the best previous CRT measurement 2. Recurrence of intraretinal cystic edema 3. Persistent intraretinal cystic edema Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant
Overall Study STARTED	3	0	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	3	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexamethasone Implant up to Every 3 Mo. n=3 Participants Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter. Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Re-implantation of Ozurdex (dexamethasone) may occur at any time \> 3 months following last injection in group 1 if any of the following conditions are met: 1. Increase of \> 50 microns from the best previous CRT measurement 2. Recurrence of intraretinal cystic edema 3. Persistent intraretinal cystic edema Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant	Dexamethasone Implant up to Every 6 Mo. Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter. Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Re-implantation of Ozurdex (dexamethasone) may occur at any time \>6 months following last injection in group 2 if any of the following conditions are met: 1. Increase of \> 50 microns from the best previous CRT measurement 2. Recurrence of intraretinal cystic edema 3. Persistent intraretinal cystic edema Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant	Sham Implant Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter. Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Also, at 13 months, patients in the sham group will be eligible for Ozurdex (dexamethasone) 0.7 mg implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2. Sham implantation may occur at any time \> 6 months following last sham injection in group 3 if any of the following conditions are met: 1. Increase of \> 50 microns from the best previous CRT measurement 2. Recurrence of intraretinal cystic edema 3. Persistent intraretinal cystic edema Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=3 Participants	—	—	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=3 Participants	—	—	1 Participants n=3 Participants
Age, Categorical >=65 years	2 Participants n=3 Participants	—	—	2 Participants n=3 Participants
Age, Continuous	69 years STANDARD_DEVIATION 0 • n=3 Participants	—	—	69 years STANDARD_DEVIATION 0 • n=3 Participants
Sex: Female, Male Female	2 Participants n=3 Participants	—	—	2 Participants n=3 Participants
Sex: Female, Male Male	1 Participants n=3 Participants	—	—	1 Participants n=3 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	3 Participants n=3 Participants	—	—	3 Participants n=3 Participants

PRIMARY outcome

Timeframe: 13 months

Population: I have entered, "0" into the results section due to the fact that this study was terminated early by the study Principal Investigator and no formal medical record extrapolation, database formation, or analysis was conducted.

Measured visual acuity gain in number of letters improved as a result of treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 year

Population: I have entered, "0" into the results section due to the fact that this study was terminated early by the study Principal Investigator and no formal medical record extrapolation, database formation, or analysis was conducted.

Central Retinal Thickness Reduction as measured by Heidelberg OCT

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Population: I have entered, "0" into the results section due to the fact that this study was terminated early by the study Principal Investigator and no formal medical record extrapolation, database formation, or analysis was conducted.

Comparison of efficacy between group 1 and group 2

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Population: I have entered, "0" into the results section due to the fact that this study was terminated early by the study Principal Investigator and no formal medical record extrapolation, database formation, or analysis was conducted.

VA gain in ETDRS letters at years 2 and years 3

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 years

Population: I have entered, "0" into the results section due to the fact that this study was terminated early by the study Principal Investigator and no formal medical record extrapolation, database formation, or analysis was conducted.

Time in months until new implant is needed

Outcome measures

Outcome data not reported

Adverse Events

Dexamethasone Implant up to Every 3 Mo.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexamethasone Implant up to Every 6 Mo.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Implant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christine Gould PAC, MS

Lahey Medical Center

Phone: 9785384412

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60