Trial Outcomes & Findings for Ranibizumab (Lucentis) for Macular Edema Secondary to Vein Occlusions (NCT NCT00407355)
NCT ID: NCT00407355
Last Updated: 2013-12-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
continuous through 72 mos
Results posted on
2013-12-04
Participant Flow
20 patients with central retinal vein occlusion(CRVO) and 20 patients with branch retinal vein occlusion (BRVO) were enrolled at the Wilmer Eye Institute
Participant milestones
| Measure |
CRVO
10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
|
BRVO
10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ranibizumab (Lucentis) for Macular Edema Secondary to Vein Occlusions
Baseline characteristics by cohort
| Measure |
CRVO
n=20 Participants
10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
|
BRVO
n=20 Participants
10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Age Continuous
|
63.9 years
STANDARD_DEVIATION 15.7 • n=93 Participants
|
67.4 years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
67.1 years
STANDARD_DEVIATION 12.5 • n=27 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
20 participants
n=4 Participants
|
40 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: continuous through 72 mosOutcome measures
| Measure |
CRVO
n=10 Participants
10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
|
BRVO
n=9 Participants
10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
|
|---|---|---|
|
Best Corrected Visual Acuity Change From Baseline at All Visits
|
10.5 ETDRS letters
Standard Deviation 9.3
|
15.1 ETDRS letters
Standard Deviation 10.7
|
PRIMARY outcome
Timeframe: continuous through 72 mosOutcome measures
| Measure |
CRVO
n=10 Participants
10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
|
BRVO
n=9 Participants
10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
|
|---|---|---|
|
Retinal Thickness Change From Baseline at All Visits
|
-379.9 microns
Standard Deviation 239.1
|
-216.9 microns
Standard Deviation 147.1
|
Adverse Events
CRVO
Serious events: 8 serious events
Other events: 8 other events
Deaths: 0 deaths
BRVO
Serious events: 6 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CRVO
n=20 participants at risk
10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
|
BRVO
n=20 participants at risk
10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
|
|---|---|---|
|
Eye disorders
Vitrectomy
|
5.0%
1/20 • Number of events 1 • 6 years
|
0.00%
0/20 • 6 years
|
|
Cardiac disorders
Transient Ischemic attack
|
5.0%
1/20 • Number of events 1 • 6 years
|
0.00%
0/20 • 6 years
|
|
Cardiac disorders
Atrial Fibrillation
|
5.0%
1/20 • Number of events 1 • 6 years
|
0.00%
0/20 • 6 years
|
|
Cardiac disorders
Mitral Valve surgery
|
5.0%
1/20 • Number of events 1 • 6 years
|
0.00%
0/20 • 6 years
|
|
Infections and infestations
Pneumonia requiring hospitalization
|
5.0%
1/20 • Number of events 1 • 6 years
|
5.0%
1/20 • Number of events 1 • 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Surgerical resection of breast cancer
|
0.00%
0/20 • 6 years
|
10.0%
2/20 • Number of events 2 • 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Surgical resection of meningioma
|
5.0%
1/20 • Number of events 1 • 6 years
|
0.00%
0/20 • 6 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic mass surgery
|
0.00%
0/20 • 6 years
|
5.0%
1/20 • Number of events 1 • 6 years
|
|
Ear and labyrinth disorders
Scheduled surgery for hearing problem
|
0.00%
0/20 • 6 years
|
5.0%
1/20 • Number of events 1 • 6 years
|
|
General disorders
Death (cause unknown)
|
10.0%
2/20 • Number of events 2 • 6 years
|
0.00%
0/20 • 6 years
|
|
General disorders
Death
|
0.00%
0/20 • 6 years
|
5.0%
1/20 • Number of events 1 • 6 years
|
Other adverse events
| Measure |
CRVO
n=20 participants at risk
10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
|
BRVO
n=20 participants at risk
10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
|
|---|---|---|
|
Infections and infestations
Respiratory Infection
|
40.0%
8/20 • Number of events 10 • 6 years
|
20.0%
4/20 • Number of events 7 • 6 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place