Trial Outcomes & Findings for Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration (NCT NCT00764738)
NCT ID: NCT00764738
Last Updated: 2020-09-22
Results Overview
As measured within the central ring of the multifocal electroretinography study this measurement is the difference between the first positive peak (P1) and the first negative peak (N1).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
91 participants
Primary outcome timeframe
One Year
Results posted on
2020-09-22
Participant Flow
Participant milestones
| Measure |
Monthly Ranibizumab 0.5 mg
Intravitreal ranibizumab 0.5 mg dosing monthly for entire study.
|
PRN Ranibizumab 0.5 mg
Intravitreal ranibizumab 0.5 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
|
Monthly Ranibizumab 2.0 mg
Intravitreal ranibizumab 2.0 mg dosing monthly for entire study.
|
PRN Ranibizumab 2.0 mg
Intravitreal ranibizumab 2.0 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
28
|
15
|
24
|
|
Overall Study
COMPLETED
|
22
|
25
|
12
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
3
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
Monthly Ranibizumab 0.5 mg
n=22 Participants
Intravitreal ranibizumab 0.5 mg dosing monthly for entire study.
|
PRN Ranibizumab 0.5 mg
n=25 Participants
Intravitreal ranibizumab 0.5 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
|
Monthly Ranibizumab 2.0 mg
n=12 Participants
Intravitreal ranibizumab 2.0 mg dosing monthly for entire study.
|
PRN Ranibizumab 2.0 mg
n=18 Participants
Intravitreal ranibizumab 2.0 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
79.6 years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
75.8 years
STANDARD_DEVIATION 0.8 • n=7 Participants
|
75.3 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
78.8 years
STANDARD_DEVIATION 1.0 • n=4 Participants
|
77.5 years
STANDARD_DEVIATION 1.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
43 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: One YearPopulation: Required maintenance on device limited data collection for part of the study population.
As measured within the central ring of the multifocal electroretinography study this measurement is the difference between the first positive peak (P1) and the first negative peak (N1).
Outcome measures
| Measure |
Monthly Ranibizumab
n=22 Participants
Intravitreal ranibizumab injections monthly for entire study.
|
PRN Ranibizumab
n=29 Participants
Intravitreal ranibizumab injections monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
|
Ranibizumab 0.5 mg
n=31 Participants
Intravitreal ranibizumab 0.5 mg dosing
|
Ranibizumab 2.0 mg
n=20 Participants
Intravitreal ranibizumab 2.0 mg dosing.
|
|---|---|---|---|---|
|
Multifocal Electroretinography N1-P1 Amplitude
Baseline
|
3.6 nV/deg^2
Standard Error 0.4
|
5.3 nV/deg^2
Standard Error 0.4
|
4.9 nV/deg^2
Standard Error 0.4
|
4.0 nV/deg^2
Standard Error 0.4
|
|
Multifocal Electroretinography N1-P1 Amplitude
1-year
|
3.4 nV/deg^2
Standard Error 0.4
|
4.7 nV/deg^2
Standard Error 0.4
|
4.4 nV/deg^2
Standard Error 0.4
|
3.6 nV/deg^2
Standard Error 0.4
|
PRIMARY outcome
Timeframe: One YearPopulation: For 4 patients, data was unavailable on microperimetry from all visits (including screening).
Outcome measures
| Measure |
Monthly Ranibizumab
n=32 Participants
Intravitreal ranibizumab injections monthly for entire study.
|
PRN Ranibizumab
n=41 Participants
Intravitreal ranibizumab injections monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
|
Ranibizumab 0.5 mg
n=43 Participants
Intravitreal ranibizumab 0.5 mg dosing
|
Ranibizumab 2.0 mg
n=30 Participants
Intravitreal ranibizumab 2.0 mg dosing.
|
|---|---|---|---|---|
|
Microperimetry Mean Sensitivity
Baseline
|
5.5 dB
Standard Error 0.8
|
5.1 dB
Standard Error 0.7
|
5.7 dB
Standard Error 0.7
|
4.6 dB
Standard Error 0.8
|
|
Microperimetry Mean Sensitivity
1-year
|
6.7 dB
Standard Error 0.7
|
7.3 dB
Standard Error 0.8
|
7.3 dB
Standard Error 0.7
|
6.6 dB
Standard Error 1.0
|
SECONDARY outcome
Timeframe: One YearOutcome measures
| Measure |
Monthly Ranibizumab
n=34 Participants
Intravitreal ranibizumab injections monthly for entire study.
|
PRN Ranibizumab
n=43 Participants
Intravitreal ranibizumab injections monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
|
Ranibizumab 0.5 mg
n=47 Participants
Intravitreal ranibizumab 0.5 mg dosing
|
Ranibizumab 2.0 mg
n=30 Participants
Intravitreal ranibizumab 2.0 mg dosing.
|
|---|---|---|---|---|
|
Best Corrected Visual Acuity
1-year
|
56.4 Letters
Standard Error 3.8
|
58.6 Letters
Standard Error 3.4
|
55.4 Letters
Standard Error 3.4
|
61.1 Letters
Standard Error 3.6
|
|
Best Corrected Visual Acuity
Baseline
|
48.7 Letters
Standard Error 4.0
|
52.6 Letters
Standard Error 3.3
|
48.6 Letters
Standard Error 3.5
|
54.5 Letters
Standard Error 3.6
|
SECONDARY outcome
Timeframe: One YearOutcome measures
| Measure |
Monthly Ranibizumab
n=34 Participants
Intravitreal ranibizumab injections monthly for entire study.
|
PRN Ranibizumab
n=43 Participants
Intravitreal ranibizumab injections monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
|
Ranibizumab 0.5 mg
n=47 Participants
Intravitreal ranibizumab 0.5 mg dosing
|
Ranibizumab 2.0 mg
n=30 Participants
Intravitreal ranibizumab 2.0 mg dosing.
|
|---|---|---|---|---|
|
Central Foveal Thickness on Optical Coherence Tomography
Baseline
|
341.2 micrometers
Standard Error 21.9
|
298.1 micrometers
Standard Error 16.8
|
308.2 micrometers
Standard Error 14.9
|
331.1 micrometers
Standard Error 26.2
|
|
Central Foveal Thickness on Optical Coherence Tomography
1-year
|
246.8 micrometers
Standard Error 17.0
|
227.9 micrometers
Standard Error 12.2
|
231.7 micrometers
Standard Error 14.3
|
242.7 micrometers
Standard Error 13.3
|
Adverse Events
Monthly Ranibizumab 0.5 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PRN Ranibizumab 0.5 mg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Monthly Ranibizumab 2.0 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PRN Ranibizumab 2.0 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Monthly Ranibizumab 0.5 mg
n=22 participants at risk
Intravitreal ranibizumab 0.5 mg dosing monthly for entire study.
|
PRN Ranibizumab 0.5 mg
n=25 participants at risk
Intravitreal ranibizumab 0.5 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
|
Monthly Ranibizumab 2.0 mg
n=12 participants at risk
Intravitreal ranibizumab 2.0 mg dosing monthly for entire study.
|
PRN Ranibizumab 2.0 mg
n=18 participants at risk
Intravitreal ranibizumab 2.0 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
|
|---|---|---|---|---|
|
Eye disorders
Uveitic Glaucoma
|
0.00%
0/22
|
4.0%
1/25
|
0.00%
0/12
|
0.00%
0/18
|
|
Eye disorders
Vitreous Hemorrhage
|
0.00%
0/22
|
4.0%
1/25
|
0.00%
0/12
|
0.00%
0/18
|
Other adverse events
| Measure |
Monthly Ranibizumab 0.5 mg
n=22 participants at risk
Intravitreal ranibizumab 0.5 mg dosing monthly for entire study.
|
PRN Ranibizumab 0.5 mg
n=25 participants at risk
Intravitreal ranibizumab 0.5 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
|
Monthly Ranibizumab 2.0 mg
n=12 participants at risk
Intravitreal ranibizumab 2.0 mg dosing monthly for entire study.
|
PRN Ranibizumab 2.0 mg
n=18 participants at risk
Intravitreal ranibizumab 2.0 mg dosing monthly for initial 4 injections followed by as needed dosing based on the presence of fluid on optical coherence tomography imaging.
|
|---|---|---|---|---|
|
Eye disorders
Corneal Abrasion
|
0.00%
0/22
|
4.0%
1/25
|
0.00%
0/12
|
0.00%
0/18
|
|
Eye disorders
Injection Site Irritation
|
4.5%
1/22
|
4.0%
1/25
|
0.00%
0/12
|
0.00%
0/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place