Trial Outcomes & Findings for Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema (NCT NCT01476449)
NCT ID: NCT01476449
Last Updated: 2019-05-17
Results Overview
The ETDRS eye chart was used to assess vision at each visit, with the change through month 24 reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Baseline through 24 months
Results posted on
2019-05-17
Participant Flow
Participant milestones
| Measure |
Monthly Ranibizumab
Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
|
Treat and Extend Ranibizumab
Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Monthly Ranibizumab
n=10 Participants
Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
|
Treat and Extend Ranibizumab
n=10 Participants
Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
12 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
8 Participants
n=20 Participants
|
|
Age, Continuous
|
64.5 years
n=10 Participants
|
60.4 years
n=10 Participants
|
62.5 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=10 Participants
|
4 Participants
n=10 Participants
|
8 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=10 Participants
|
6 Participants
n=10 Participants
|
12 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: Baseline through 24 monthsThe ETDRS eye chart was used to assess vision at each visit, with the change through month 24 reported.
Outcome measures
| Measure |
Monthly Ranibizumab
n=10 Participants
Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
|
Treat and Extend Ranibizumab
n=10 Participants
Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
|
|---|---|---|
|
Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision.
|
8.3 ETDRS Letters
Standard Deviation 7.2
|
8.5 ETDRS Letters
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: 24 monthsThe average number of intravitreal ranibizumab injections in each arm of the study will be recorded.
Outcome measures
| Measure |
Monthly Ranibizumab
n=10 Participants
Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
|
Treat and Extend Ranibizumab
n=10 Participants
Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
|
|---|---|---|
|
Mean Number of Injections.
|
19.4 injections
Standard Deviation 5.9
|
18.8 injections
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 24 monthsEvaluate the average change in the swelling from diabetic macular edema measured with the optical coherence tomography machine.
Outcome measures
| Measure |
Monthly Ranibizumab
n=10 Participants
Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
|
Treat and Extend Ranibizumab
n=10 Participants
Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
|
|---|---|---|
|
Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT).
|
-169.0 microns
Standard Deviation 98.5
|
-146.8 microns
Standard Deviation 122.0
|
SECONDARY outcome
Timeframe: 24 monthsThe percentage of patients with 20/40 vision as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 20 feet.
Outcome measures
| Measure |
Monthly Ranibizumab
n=10 Participants
Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
|
Treat and Extend Ranibizumab
n=10 Participants
Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
|
|---|---|---|
|
Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better.
|
10 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 24 MonthsSpectral domain OCT will be used to check the patients' central foveal thickness at each visit and the percentage with "dry" maculas at months 3,6, and 12 based on spectral domain OCT measurements per the study protocol will be recorded.
Outcome measures
| Measure |
Monthly Ranibizumab
n=10 Participants
Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
|
Treat and Extend Ranibizumab
n=10 Participants
Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
|
|---|---|---|
|
Percentage of Patients Anatomically "Dry."
|
8 Participants
|
7 Participants
|
Adverse Events
Monthly Ranibizumab
Serious events: 3 serious events
Other events: 0 other events
Deaths: 1 deaths
Treat and Extend Ranibizumab
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Monthly Ranibizumab
n=10 participants at risk
Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
|
Treat and Extend Ranibizumab
n=10 participants at risk
Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
|
|---|---|---|
|
Cardiac disorders
Death
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Cardiac disorders
Myocardial Infarction
|
20.0%
2/10 • Number of events 2
|
0.00%
0/10
|
Other adverse events
| Measure |
Monthly Ranibizumab
n=10 participants at risk
Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
|
Treat and Extend Ranibizumab
n=10 participants at risk
Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended.
Ranibizumab: Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
|
|---|---|---|
|
Eye disorders
Vitreous Hemorrhage
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
Additional Information
David Eichenbaum, MD
Retina Vitreous Associates of Florida
Phone: 727-323-0077
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place