Not provided
Not provided
Not provided
Not provided
Not provided
Study withdrawn by Investigator
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Currently medications injected intravitreally in previously vitrectomized eyes have a very short half-life due to enhanced clearance of the drug. The use of the Ozurdex (dexamethasone) implant may allow sustained levels of steroid delivery to patients with diabetic macular edema that have undergone prior vitrectomy. The sustained steroid levels may lead to improved central retinal thickness measurements and improved visual acuity.
A total of 15 patients will be enrolled into the study. This is a 3 year randomized controlled study with the primary endpoint at 1 year. Secondary safety and efficacy endpoints will be evaluated in year 2 and year 3.
Patients will be randomly enrolled into 1 of 3 groups:
Group 1: Dexamethasone administered up to every 3 months Group 2: Dexamethasone administered up to every 6 months Group 3: Sham
Patients will be evaluated on a monthly basis with ETDRS visual acuity, intraocular pressure, fundus examination and OCT.
Ozurdex (dexamethasone) or Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter. One month following initial injection/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.
Re-implantation of Ozurdex may occur at any time > 3 months following last injection in group 1 and > 6 months following last injection in group 2 if any of the following conditions are met:
At 13 months, patients in the sham group will be eligible for Ozurdex implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2 (up to every 6 months).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone implant up to every 3 Mo. | Active Comparator | 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:
|
|
| Dexamethasone implant up to every 6 Mo. | Active Comparator | 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:
|
|
| Sham Implant | Sham Comparator | 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:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Ozurdex (dexamethasone) 0.7mg steroid implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity Gain | Measured visual acuity gain in number of letters improved as a result of treatment | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Central Retinal Thickness Reduction | Central Retinal Thickness Reduction as measured by Heidelberg OCT | 1 year |
| Comparison of Efficacy Between Group 1 and 2 | Comparison of efficacy between group 1 and group 2 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fina C Barouch, MD | Lahey Clinic | Principal Investigator |
| Jeffrey L Marx, MD | Lahey Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lahey Medical Center, One Essex Center Drive | Peabody | Massachusetts | 01960 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19273785 | Background | Diabetic Retinopathy Clinical Research Network (DRCR.net); Beck RW, Edwards AR, Aiello LP, Bressler NM, Ferris F, Glassman AR, Hartnett E, Ip MS, Kim JE, Kollman C. Three-year follow-up of a randomized trial comparing focal/grid photocoagulation and intravitreal triamcinolone for diabetic macular edema. Arch Ophthalmol. 2009 Mar;127(3):245-51. doi: 10.1001/archophthalmol.2008.610. | |
| 21813090 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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:
Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant |
| FG001 | 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:
Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant |
| FG002 | 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:
Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The 3 subjects were withdrawn from the study and returned to standard of care treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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:
Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Acuity Gain | Measured visual acuity gain in number of letters improved as a result of treatment | 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. | Posted | 13 months |
|
Baseline through study termination.
This study was terminated early by the study Principal Investigator. All 3 subjects were enrolled in the study, but were converted to standard of care less than 6 months from enrollment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant |
Not provided
Not provided
The study was terminated early leading to small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Gould PAC, MS | Lahey Medical Center | 9785384412 | christine.gould@lahey.org |
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 3 years |
| Visual Acuity Gain at Year 2 and 3 | VA gain in ETDRS letters at years 2 and years 3 | 3 years |
| Time to Reimplantation of Ozurdex Implant | Time in months until new implant is needed | 3 years |
| Background |
| Pearson PA, Comstock TL, Ip M, Callanan D, Morse LS, Ashton P, Levy B, Mann ES, Eliott D. Fluocinolone acetonide intravitreal implant for diabetic macular edema: a 3-year multicenter, randomized, controlled clinical trial. Ophthalmology. 2011 Aug;118(8):1580-7. doi: 10.1016/j.ophtha.2011.02.048. |
| BG001 | 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:
Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant |
| BG002 | 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:
Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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:
Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant |
| OG002 | 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:
Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant |
|
| Secondary | Central Retinal Thickness Reduction | Central Retinal Thickness Reduction as measured by Heidelberg OCT | 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. | Posted | 1 year |
|
|
| Secondary | Comparison of Efficacy Between Group 1 and 2 | Comparison of efficacy between group 1 and group 2 | 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. | Posted | 3 years |
|
|
| Secondary | Visual Acuity Gain at Year 2 and 3 | VA gain in ETDRS letters at years 2 and years 3 | 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. | Posted | 3 years |
|
|
| Secondary | Time to Reimplantation of Ozurdex Implant | Time in months until new implant is needed | 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. | Posted | 3 years |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | 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:
Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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:
Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| >=65 years |
|