Trial Outcomes & Findings for Evaluation of Vitrectomy for Diabetic Macular Edema (NCT NCT00709319)
NCT ID: NCT00709319
Last Updated: 2019-10-07
Results Overview
Change in best correct visual acuity letter score from baseline to six months as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
Recruitment status
COMPLETED
Target enrollment
87 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2019-10-07
Participant Flow
Participant milestones
| Measure |
Diabetic Macular Edema and Vitreomacular Traction
The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
|
|---|---|
|
Overall Study
STARTED
|
87
|
|
Overall Study
COMPLETED
|
81
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Diabetic Macular Edema and Vitreomacular Traction
The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
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|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Evaluation of Vitrectomy for Diabetic Macular Edema
Baseline characteristics by cohort
| Measure |
Diabetic Macular Edema and Vitreomacular Traction
n=87 Participants
The primary cohort included 87 eyes with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year. Only one eye per participant could be enrolled.
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|---|---|
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Age, Customized
|
66 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
69 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=5 Participants
|
|
Surgery characteristic: Focal/grid laser to diabetic macular edema used
Yes
|
4 Participants
n=5 Participants
|
|
Surgery characteristic: Focal/grid laser to diabetic macular edema used
No
|
83 Participants
n=5 Participants
|
|
Surgery characteristic: Panretinal photocoagulation, history of prior use
Yes
|
16 Participants
n=5 Participants
|
|
Surgery characteristic: Panretinal photocoagulation, history of prior use
No
|
71 Participants
n=5 Participants
|
|
Indocyanine green used to improve visualization
Yes
|
24 Participants
n=5 Participants
|
|
Indocyanine green used to improve visualization
No
|
63 Participants
n=5 Participants
|
|
Diabetes Type
Type 1
|
14 Participants
n=5 Participants
|
|
Diabetes Type
Type 2
|
73 Participants
n=5 Participants
|
|
Epiretinal Membranes Present
No
|
21 Participants
n=5 Participants
|
|
Epiretinal Membranes Present
Probable
|
19 Participants
n=5 Participants
|
|
Epiretinal Membranes Present
Definite
|
43 Participants
n=5 Participants
|
|
Epiretinal Membranes Present
Can not deterimine
|
4 Participants
n=5 Participants
|
|
Lens Status
Phakic
|
37 Participants
n=5 Participants
|
|
Lens Status
Pseudophakic/aphakic
|
50 Participants
n=5 Participants
|
|
Prior Scatter Photocoagulation
Yes
|
39 Participants
n=5 Participants
|
|
Prior Scatter Photocoagulation
No
|
48 Participants
n=5 Participants
|
|
Prior Treatment for Diabetic Macular Edema
Yes
|
51 Participants
n=5 Participants
|
|
Prior Treatment for Diabetic Macular Edema
No
|
36 Participants
n=5 Participants
|
|
Reasons for Vitrectomy: Vitreomacular interface abnormality
|
87 Participants
n=5 Participants
|
|
Retinopathy Severity
Microaneurysms only
|
1 Participants
n=5 Participants
|
|
Retinopathy Severity
Mild/moderate nonproliferative diabetic retinopath
|
6 Participants
n=5 Participants
|
|
Retinopathy Severity
Moderate/severe nonproliferative diabetic retinopa
|
14 Participants
n=5 Participants
|
|
Retinopathy Severity
Severe nonproliferative diabetic retinopathy
|
4 Participants
n=5 Participants
|
|
Retinopathy Severity
Proliferative diabetic retinopathy
|
51 Participants
n=5 Participants
|
|
Retinopathy Severity
Retinal volume not obtained
|
11 Participants
n=5 Participants
|
|
Status of the Vitreous
Attached
|
49 Participants
n=5 Participants
|
|
Status of the Vitreous
Partially Attached
|
28 Participants
n=5 Participants
|
|
Status of the Vitreous
Detached
|
5 Participants
n=5 Participants
|
|
Status of the Vitreous
Uncertain
|
5 Participants
n=5 Participants
|
|
Triamcinolone acetonide used to improve visualization
Yes
|
30 Participants
n=5 Participants
|
|
Triamcinolone acetonide used to improve visualization
No
|
57 Participants
n=5 Participants
|
|
Surgical Characteristic: Internal Limiting Membrane Removed
Yes
|
47 Participants
n=5 Participants
|
|
Surgical Characteristic: Internal Limiting Membrane Removed
No
|
40 Participants
n=5 Participants
|
|
Surgical Characteristic: Focal to grid breaks Laser Used
Yes
|
14 Participants
n=5 Participants
|
|
Surgical Characteristic: Focal to grid breaks Laser Used
No
|
73 Participants
n=5 Participants
|
|
Surgical Characteristic: Vitrectomy System
19/20 gauge
|
35 Participants
n=5 Participants
|
|
Surgical Characteristic: Vitrectomy System
25 gauge
|
43 Participants
n=5 Participants
|
|
Surgical Characteristic: Vitrectomy System
23 gauge
|
9 Participants
n=5 Participants
|
|
Surgical Charachteristic:Epiretinal membrane peeled
Yes
|
53 Participants
n=5 Participants
|
|
Surgical Charachteristic:Epiretinal membrane peeled
No
|
34 Participants
n=5 Participants
|
|
Central Subfield Thickness
|
491 Microns
n=5 Participants
|
|
Duration of Diabetes
|
20 Years
n=5 Participants
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|
Electronic-Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score
|
52 Number on a Scale
n=5 Participants
|
|
Hemoglobin A1c
|
7.1 Percent
n=5 Participants
|
|
Retinal Volume
|
9.2 mm3
n=5 Participants
|
|
Reasons for Vitrectomy: Unresponsive to other therapies
Yes
|
27 Participants
n=5 Participants
|
|
Reasons for Vitrectomy: Unresponsive to other therapies
No
|
60 Participants
n=5 Participants
|
|
Trypan blue used to improve visualization
Yes
|
2 Participants
n=5 Participants
|
|
Trypan blue used to improve visualization
No
|
85 Participants
n=5 Participants
|
|
Surgery characteristic: Panretinal photocoagulation, with none used prior
Yes
|
19 Participants
n=5 Participants
|
|
Surgery characteristic: Panretinal photocoagulation, with none used prior
No
|
68 Participants
n=5 Participants
|
|
Surgery characteristic: Laser used with endoprobe
Yes
|
21 Participants
n=5 Participants
|
|
Surgery characteristic: Laser used with endoprobe
No
|
66 Participants
n=5 Participants
|
|
Surgery characteristic: Laser used with indirect ophthalmoscope
Yes
|
7 Participants
n=5 Participants
|
|
Surgery characteristic: Laser used with indirect ophthalmoscope
No
|
80 Participants
n=5 Participants
|
|
Surgery characteristic: Scatter laser over peripheral schisis or barrier laser used
Yes
|
4 Participants
n=5 Participants
|
|
Surgery characteristic: Scatter laser over peripheral schisis or barrier laser used
No
|
83 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsChange in best correct visual acuity letter score from baseline to six months as measured by a certified tester using an electronic visual acuity testing machine based on the Early Treatment Diabetic Retinopathy Study (ETDRS) method. A positive change denotes an improvement. Best value on the scale 97, worst 0.
Outcome measures
| Measure |
Diabetic Macular Edema and Vitreomacular Traction
n=87 Participants
The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
|
|---|---|
|
Visual Acuity
|
52 Units on a scale
Interval 42.0 to 64.0
|
PRIMARY outcome
Timeframe: Baseline to 6 MonthsChange in central subfield thickness is followup central subfield retinal thickness minus baseline thickness.
Outcome measures
| Measure |
Diabetic Macular Edema and Vitreomacular Traction
n=87 Participants
The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
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|---|---|
|
Change in Optical Coherence Tomography Measured Central Subfield Thickness From Baseline
|
-160 microns
Interval -258.0 to -87.0
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsOutcome measures
| Measure |
Diabetic Macular Edema and Vitreomacular Traction
n=87 Participants
The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
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|---|---|
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Percent of Participants With Change in Visual Acuity From Baseline to Six Months
Percent with 10 or more letter imporvement
|
38 Percentage of Participants
Interval 28.0 to 49.0
|
|
Percent of Participants With Change in Visual Acuity From Baseline to Six Months
Percent with 10 or more letters worsening
|
22 Percentage of Participants
Interval 13.0 to 31.0
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsChange in thickness is followup thickness minus baseline thickness.
Outcome measures
| Measure |
Diabetic Macular Edema and Vitreomacular Traction
n=87 Participants
The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
|
|---|---|
|
Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 6 Months
Central subfield decrease of 100 microns or more
|
49 participants
|
|
Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 6 Months
Central subfield decrease of 50 microns or more
|
61 participants
|
|
Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 6 Months
Central subfield increase of 50 microns or more
|
3 participants
|
|
Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 6 Months
Central subfield thickening decrease of >=50%
|
50 participants
|
|
Change in Optical Coherence Tomography Central Subfield Thickness From Baseline to 6 Months
Central subfield less than 250 microns at 6 months
|
33 participants
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsIncluding intraoperative and perioperative medical complications. Same subject could have more than one complication
Outcome measures
| Measure |
Diabetic Macular Edema and Vitreomacular Traction
n=87 Participants
The primary cohort included 87 eyes (one eye per participant) with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year.
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|---|---|
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Surgical Complications From Baseline to Six Months
Choroidal effusion
|
1 Participants
|
|
Surgical Complications From Baseline to Six Months
Total
|
16 Participants
|
|
Surgical Complications From Baseline to Six Months
Vitreous hemorrhage
|
5 Participants
|
|
Surgical Complications From Baseline to Six Months
Additional vitreomacular interface abnormalities
|
2 Participants
|
|
Surgical Complications From Baseline to Six Months
Elevated intraocular pressure requiring treatment
|
7 Participants
|
|
Surgical Complications From Baseline to Six Months
Retinal Detachment
|
3 Participants
|
|
Surgical Complications From Baseline to Six Months
Endophthalmitis
|
1 Participants
|
|
Surgical Complications From Baseline to Six Months
Double vision
|
2 Participants
|
|
Surgical Complications From Baseline to Six Months
Lamella hole
|
1 Participants
|
|
Surgical Complications From Baseline to Six Months
Other
|
2 Participants
|
Adverse Events
Diabetic Macular Edema and Vitreomacular Traction
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Diabetic Macular Edema and Vitreomacular Traction
n=87 participants at risk
The primary cohort included 87 eyes with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year. Only one eye per participant could be enrolled.
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|---|---|
|
Eye disorders
retinal detachment
|
3.4%
3/87
|
|
Eye disorders
Endophthalmitis
|
1.1%
1/87
|
Other adverse events
| Measure |
Diabetic Macular Edema and Vitreomacular Traction
n=87 participants at risk
The primary cohort included 87 eyes with DME and vitreomacular traction based on investigator's evaluation, visual acuity 20/63-20/400, optical coherence tomography (OCT) central subfield greater than 300 microns and no concomitant cataract extraction at the time of vitrectomy.Surgery was performed according to the investigator's usual routine. Follow-up visits were performed after 3 months, 6 months (primary end point), and 1 year. Only one eye per participant could be enrolled.
|
|---|---|
|
Eye disorders
Vitreous haemorrhage
|
5.7%
5/87
|
|
Eye disorders
Additional vitreomacular interface abnormalities
|
2.3%
2/87
|
|
Eye disorders
Elevated intraocular pressure requirering treatment
|
8.0%
7/87
|
|
Eye disorders
Double Vision
|
2.3%
2/87
|
|
Eye disorders
Lamella hole
|
1.1%
1/87
|
|
Eye disorders
Choroidal effusion
|
1.1%
1/87
|
Additional Information
Adam R. Glassman, Director DRCR.net Coordinating Center
Jaeb Center for Health Research
Phone: 813-975-8690
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place