Trial Outcomes & Findings for Ranibizumab and Peripheral Scatter Laser in Patients With Diabetic Macular Edema and Peripheral Nonperfusion (NCT NCT00815360)
NCT ID: NCT00815360
Last Updated: 2015-03-05
Results Overview
COMPLETED
PHASE2
22 participants
6 months
2015-03-05
Participant Flow
We included 30 treatment-naïve eyes of 22 patients (8 bilateral patients) aged ≥ 18 years of age, with Type 1 or 2 diabetes mellitus and visual impairment secondary to diabetic macular edema associated with peripheral nonperfusion on Ultra Widefield Fluorescein Angiography (UWFA).
Treatment naive patients
Participant milestones
| Measure |
Treatment Group 1
ranibizumab and scatter laser
|
Comparative Group 1
Intravitreal triamcinolone with macular laser
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ranibizumab and Peripheral Scatter Laser in Patients With Diabetic Macular Edema and Peripheral Nonperfusion
Baseline characteristics by cohort
| Measure |
Treatment Group 1
n=11 Participants
ranibizumab and scatter laser
|
Comparative Group 1
n=11 Participants
Intravitreal triamcinolone with macular laser
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 7.5 • n=99 Participants
|
58.3 years
STANDARD_DEVIATION 6.5 • n=107 Participants
|
58.0 years
STANDARD_DEVIATION 7.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
11 participants
n=107 Participants
|
22 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: We included 30 treatment-naïve eyes of 22 patients (8 bilateral patients) aged ≥ 18 years of age, with Type 1 or 2 diabetes mellitus and visual impairment secondary to diabetic macular edema associated with peripheral nonperfusion on UWFA.
Outcome measures
| Measure |
Treatment Group 1
n=15 Eyes
ranibizumab and scatter laser
|
Comparative Group 1
n=15 Eyes
Intravitreal triamcinolone with macular laser
|
|---|---|---|
|
Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters From Baseline to Month 6.
|
13 Letters of visual acuity on ETDRS chart
Interval 9.0 to 15.0
|
10 Letters of visual acuity on ETDRS chart
Interval 7.0 to 13.0
|
SECONDARY outcome
Timeframe: 6 monthsOutcome measures
| Measure |
Treatment Group 1
n=15 Eyes
ranibizumab and scatter laser
|
Comparative Group 1
n=15 Eyes
Intravitreal triamcinolone with macular laser
|
|---|---|---|
|
Mean Central Foveal Thickness (CFT) on Optical Coherence Tomography (OCT) in Microns at 6 Months
|
270 units on a scale (microns)
Interval 240.0 to 310.0
|
350 units on a scale (microns)
Interval 280.0 to 400.0
|
Adverse Events
Treatment Group 1
Comparative Group 1
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place