Trial Outcomes & Findings for Lucentis in Advanced Macular Degeneration (NCT NCT00896779)
NCT ID: NCT00896779
Last Updated: 2015-06-29
Results Overview
Change in vision from baseline measurement at 12 months. Standard ETDRS chart (80 letters) was used to determine visual acuity with test luminance of 45 cd/m \^2 at 8 feet. Number of correctly read letters were reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
12 months
Results posted on
2015-06-29
Participant Flow
Participant milestones
| Measure |
Ranibizumab Group 1
Group 1: 3 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
|
Ranibizumab Group 2
Group 1: 6 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
12
|
|
Overall Study
COMPLETED
|
8
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lucentis in Advanced Macular Degeneration
Baseline characteristics by cohort
| Measure |
Ranibizumab Group 1
n=8 Participants
Group 1: 3 monthly injections of 0.5mg then prn
|
Ranibizumab Group 2
n=12 Participants
Group 2: 6 monthly injecions of 0.5mg then prn
|
Total
n=20 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Age, Continuous
|
81 years
n=99 Participants
|
84 years
n=107 Participants
|
83 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
12 participants
n=107 Participants
|
20 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsChange in vision from baseline measurement at 12 months. Standard ETDRS chart (80 letters) was used to determine visual acuity with test luminance of 45 cd/m \^2 at 8 feet. Number of correctly read letters were reported.
Outcome measures
| Measure |
Ranibizumab Group 1
n=8 Participants
Group 1: 3 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
|
Ranibizumab Group 2
n=12 Participants
Group 2: 6 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
|
|---|---|---|
|
Mean Change in Visual Acuity
|
15.0 letters
Standard Deviation 14.2
|
5.6 letters
Standard Deviation 8.6
|
Adverse Events
Ranibizumab Group 1
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Ranibizumab Group 2
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ranibizumab Group 1
n=8 participants at risk
Group 1: 3 monthly injections of 0.5mg then prn
|
Ranibizumab Group 2
n=12 participants at risk
Group 2: 6 monthly injections of 0.5 mg then prn
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
laceration right leg
|
12.5%
1/8 • 12 months
|
0.00%
0/12 • 12 months
|
|
Skin and subcutaneous tissue disorders
laceration left leg
|
12.5%
1/8 • 12 months
|
0.00%
0/12 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Mild pneumonia
|
12.5%
1/8 • 12 months
|
0.00%
0/12 • 12 months
|
|
Immune system disorders
Seasonal allergies
|
12.5%
1/8 • 12 months
|
0.00%
0/12 • 12 months
|
|
Eye disorders
Worsening glaucoma - which eye was not specified
|
12.5%
1/8 • 12 months
|
0.00%
0/12 • 12 months
|
|
Eye disorders
visual disturbance - fellow eye
|
12.5%
1/8 • 12 months
|
0.00%
0/12 • 12 months
|
|
Eye disorders
development of choroidal neovascularization - fellow eye
|
12.5%
1/8 • 12 months
|
0.00%
0/12 • 12 months
|
|
Musculoskeletal and connective tissue disorders
bruised sturnum
|
12.5%
1/8 • 12 months
|
0.00%
0/12 • 12 months
|
|
Eye disorders
subconjuctival hemorrhage - treatment eye
|
12.5%
1/8 • 12 months
|
0.00%
0/12 • 12 months
|
|
Eye disorders
intraretinal hemorrhage - treatment eye
|
12.5%
1/8 • 12 months
|
0.00%
0/12 • 12 months
|
|
Metabolism and nutrition disorders
vitamin D deficiency
|
12.5%
1/8 • 12 months
|
0.00%
0/12 • 12 months
|
|
Gastrointestinal disorders
intestinal flu
|
12.5%
1/8 • Number of events 2 • 12 months
|
0.00%
0/12 • 12 months
|
|
Skin and subcutaneous tissue disorders
rash
|
12.5%
1/8 • 12 months
|
0.00%
0/12 • 12 months
|
|
Nervous system disorders
pinched nerve
|
12.5%
1/8 • 12 months
|
0.00%
0/12 • 12 months
|
|
Nervous system disorders
stroke
|
0.00%
0/8 • 12 months
|
8.3%
1/12 • 12 months
|
|
Eye disorders
endophthalmitis - fellow eye
|
0.00%
0/8 • 12 months
|
8.3%
1/12 • 12 months
|
|
Immune system disorders
cold
|
0.00%
0/8 • 12 months
|
8.3%
1/12 • 12 months
|
|
Eye disorders
ache left eye - treatment eye
|
0.00%
0/8 • 12 months
|
8.3%
1/12 • 12 months
|
|
Eye disorders
corneal abrasion - both eyes
|
0.00%
0/8 • 12 months
|
8.3%
1/12 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place