Trial Outcomes & Findings for Ranibizumab for Treatment of Persistent Diabetic Neovascularization Assessed by Wide-Field Imaging (NCT NCT00606138)
NCT ID: NCT00606138
Last Updated: 2023-04-10
Results Overview
This is a measurement of how much change in neovascularization has occurred, using the Optomap FA readings to calculate the increase or decrease in surface area of the retina that is affected by neovascularization.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Baseline to Week 4; Baseline to Month 4-6
Results posted on
2023-04-10
Participant Flow
Subjects will be recruited starting in 2007 and until sufficient subject population is reached. They will be seen in an eye clinic at Rush University Medical Center.
There is no wash-out period. Recruited subjects must be in need of treatment for their PDR, and will be randomized and treated at the baseline visit. There were a total of 8 participants treated.
Participant milestones
| Measure |
1 - Ranibizumab
Intravitreal injection of 0.5-mg dose of ranibizumab
|
2 - Additional PRP Treatment
Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
|
Overall Study
COMPLETED
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ranibizumab for Treatment of Persistent Diabetic Neovascularization Assessed by Wide-Field Imaging
Baseline characteristics by cohort
| Measure |
1 - Ranibizumab
n=6 Participants
Intravitreal injection of 0.5-mg dose of ranibizumab
|
2 - Additional PRP Treatment
n=2 Participants
Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
57 years
n=5 Participants
|
67 years
n=7 Participants
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4; Baseline to Month 4-6This is a measurement of how much change in neovascularization has occurred, using the Optomap FA readings to calculate the increase or decrease in surface area of the retina that is affected by neovascularization.
Outcome measures
| Measure |
1 - Ranibizumab
n=6 Participants
Intravitreal injection of 0.5-mg dose of ranibizumab
|
2 - Additional PRP Treatment
n=2 Participants
Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
|
|---|---|---|
|
The Mean Percentage Change of the Area of the Patient's Neovascularization as Measured in Pixels by Optomap FA (Fluorescein Angiography)
Change at Week 4 from baseline
|
-83.8 percentage of change in area (mean)
Standard Deviation NA
Data can't be calculated due to lack of original case reports
|
52.6 percentage of change in area (mean)
Standard Deviation NA
Data can't be calculated due to lack of original case reports
|
|
The Mean Percentage Change of the Area of the Patient's Neovascularization as Measured in Pixels by Optomap FA (Fluorescein Angiography)
Change at Month 4-6 from baseline
|
11.3 percentage of change in area (mean)
Standard Deviation NA
Data can't be calculated due to lack of original case reports
|
55.4 percentage of change in area (mean)
Standard Deviation NA
Data can't be calculated due to lack of original case reports
|
PRIMARY outcome
Timeframe: Baseline to Week 4; Baseline to Month 6Outcome measures
| Measure |
1 - Ranibizumab
n=6 Participants
Intravitreal injection of 0.5-mg dose of ranibizumab
|
2 - Additional PRP Treatment
n=2 Participants
Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
|
|---|---|---|
|
The Mean Percentage Change of Macular Edema Measured by Retinal Thickness by OCT (Optical Coherence Tomography)
Change from Baseline to Week 4
|
-2.4 percentage of change (mean)
Standard Deviation NA
Data can't be calculated due to lack of original case reports
|
-8.4 percentage of change (mean)
Standard Deviation NA
Data can't be calculated due to lack of original case reports
|
|
The Mean Percentage Change of Macular Edema Measured by Retinal Thickness by OCT (Optical Coherence Tomography)
Change from baseline to Month 6
|
54.1 percentage of change (mean)
Standard Deviation NA
Data can't be calculated due to lack of original case reports
|
-2.1 percentage of change (mean)
Standard Deviation NA
Data can't be calculated due to lack of original case reports
|
PRIMARY outcome
Timeframe: Month 6Outcome measures
| Measure |
1 - Ranibizumab
n=6 Participants
Intravitreal injection of 0.5-mg dose of ranibizumab
|
2 - Additional PRP Treatment
n=2 Participants
Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
|
|---|---|---|
|
Incidence and Severity of Ocular Adverse Events, as Identified by Ophthalmic Examination
|
0 number of events
|
1 number of events
|
PRIMARY outcome
Timeframe: Week 1, 2, 4; Month 2, 3, 4, 5, 6Patients were randomized to receive IVR vs. additional PRP. Number of participants with adverse events.
Outcome measures
| Measure |
1 - Ranibizumab
n=6 Participants
Intravitreal injection of 0.5-mg dose of ranibizumab
|
2 - Additional PRP Treatment
n=2 Participants
Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
|
|---|---|---|
|
Number of Participants With Occurrence of Adverse Events
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 Month; 6 monthsOutcome measures
| Measure |
1 - Ranibizumab
n=6 Participants
Intravitreal injection of 0.5-mg dose of ranibizumab
|
2 - Additional PRP Treatment
n=2 Participants
Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
|
|---|---|---|
|
Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Lines Gained on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters
Week 4
|
2 lines of vision gained
Standard Deviation 1
|
0 lines of vision gained
Standard Deviation 1
|
|
Mean Change in Best Corrected Visual Acuity (BCVA), as Assessed by the Number of Lines Gained on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters
Month 6
|
3 lines of vision gained
Standard Deviation 1.5
|
2 lines of vision gained
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: 1 month, 6 monthsOutcome measures
| Measure |
1 - Ranibizumab
n=4 Participants
Intravitreal injection of 0.5-mg dose of ranibizumab
|
2 - Additional PRP Treatment
n=2 Participants
Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
|
|---|---|---|
|
Percentage of Patients Gaining 3 or More Lines of Vision According to ETDRS Eye Chart Testing
Percentage of Participants with Lines gained in BCVA at 1 mos
|
50.0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Patients Gaining 3 or More Lines of Vision According to ETDRS Eye Chart Testing
Percentage of Participants with Lines gained in BCVA at 6 mos
|
75.0 percentage of participants
|
33.33 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthComplications; including vitreous hemorrhage, iris neovascularization, and tractional retinal detachment were assessed at the 6 month time point and are reported below.
Outcome measures
| Measure |
1 - Ranibizumab
n=6 Participants
Intravitreal injection of 0.5-mg dose of ranibizumab
|
2 - Additional PRP Treatment
n=2 Participants
Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
|
|---|---|---|
|
Occurrence Rate of Proliferative Diabetic Complications Including Vitreous Hemorrhage, Iris Neovascularization, and Tractional Retinal Detachment
|
0 number of PDR complications
|
1 number of PDR complications
|
Adverse Events
1 - Ranibizumab
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2 - Additional PRP Treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1 - Ranibizumab
n=6 participants at risk
Intravitreal injection of 0.5-mg dose of ranibizumab
|
2 - Additional PRP Treatment
n=2 participants at risk
Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
|
|---|---|---|
|
Eye disorders
Eye injury, mild, unrelated to treatment
|
0.00%
0/6 • Up to a maximum of 6 months or 14 days after early study withdrawal.
There are no oddities regarding definitions of adverse events for this study nor the collection or reporting thereof.
|
50.0%
1/2 • Number of events 1 • Up to a maximum of 6 months or 14 days after early study withdrawal.
There are no oddities regarding definitions of adverse events for this study nor the collection or reporting thereof.
|
|
Eye disorders
Vitreous Hemorrhage
|
0.00%
0/6 • Up to a maximum of 6 months or 14 days after early study withdrawal.
There are no oddities regarding definitions of adverse events for this study nor the collection or reporting thereof.
|
50.0%
1/2 • Number of events 1 • Up to a maximum of 6 months or 14 days after early study withdrawal.
There are no oddities regarding definitions of adverse events for this study nor the collection or reporting thereof.
|
Additional Information
Mathew MacCumber, MD, PhD
Rush University Medical Center
Phone: 312-563-4032
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place