Trial Outcomes & Findings for Ranibizumab (Lucentis) for Polypoidal Choroidal Vasculopathy (NCT NCT00837330)
NCT ID: NCT00837330
Last Updated: 2019-04-16
Results Overview
Incidence and severity of ocular adverse events, as identified by indirect and direct examination. Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more of clinical macula (arcade to arcade), disease-related vitreous hemorrhage, injection-related endopthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
20 participants
Primary outcome timeframe
2 years
Results posted on
2019-04-16
Participant Flow
Twenty subjects from one site in the United States will be enrolled. Subjects with active, exudative-PCV who have provided informed consent will be eligible. Date of first subject enrolled: May 19, 2006. Date of last subject enrolled: October 8, 2008.
Participant milestones
| Measure |
Intraocular Injection 0.5 mg Ranibizumab
10 patients will receive intraocular injection 0.5 mg ranibizumab
|
Intraocular Injection 0.3 mg Ranibizumab
10 patients will receive intraocular injection 0.3 mg ranibizumab
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Intraocular Injection 0.5 mg Ranibizumab
10 patients will receive intraocular injection 0.5 mg ranibizumab
|
Intraocular Injection 0.3 mg Ranibizumab
10 patients will receive intraocular injection 0.3 mg ranibizumab
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
Ranibizumab (Lucentis) for Polypoidal Choroidal Vasculopathy
Baseline characteristics by cohort
| Measure |
Ranibizumab 0.5 mg/ 0.05 cc
n=10 Participants
Intraocular injection of 0.5 mg /0.05 cc ranibizumab
|
Ranibizumab 0.3 mg/ 0.05 cc
n=10 Participants
Intraocular injection of 0.3 mg /0.05 cc ranibizumab
|
Total
n=20 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
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 14 • n=5 Participants
|
65 years
STANDARD_DEVIATION 8 • n=7 Participants
|
64 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsIncidence and severity of ocular adverse events, as identified by indirect and direct examination. Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more of clinical macula (arcade to arcade), disease-related vitreous hemorrhage, injection-related endopthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs.
Outcome measures
| Measure |
Ranibizumab 0.5 mg
n=10 Participants
Intraocular injection of 0.5 mg ranibizumab
|
Ranibizumab 0.3 mg
n=10 Participants
Intraocular injection 0.3 mg ranibizumab
|
|---|---|---|
|
Commonly Reported and Notable Adverse Events
Spider webs
|
1 participants
|
2 participants
|
|
Commonly Reported and Notable Adverse Events
Eye pain, burning
|
2 participants
|
3 participants
|
|
Commonly Reported and Notable Adverse Events
Wavy Lines
|
1 participants
|
2 participants
|
|
Commonly Reported and Notable Adverse Events
Seeing Dark spots
|
2 participants
|
2 participants
|
|
Commonly Reported and Notable Adverse Events
Flashes of Light
|
1 participants
|
1 participants
|
|
Commonly Reported and Notable Adverse Events
Floaters
|
4 participants
|
1 participants
|
|
Commonly Reported and Notable Adverse Events
Worsening visual acuity
|
2 participants
|
1 participants
|
|
Commonly Reported and Notable Adverse Events
Eye irritation
|
1 participants
|
2 participants
|
|
Commonly Reported and Notable Adverse Events
Mild Vitreous Hemorrhage
|
1 participants
|
2 participants
|
|
Commonly Reported and Notable Adverse Events
Blurry vision
|
2 participants
|
3 participants
|
|
Commonly Reported and Notable Adverse Events
Eyelid swelling
|
2 participants
|
1 participants
|
|
Commonly Reported and Notable Adverse Events
Transient increased blood pressure
|
0 participants
|
2 participants
|
|
Commonly Reported and Notable Adverse Events
Injection-related pain
|
2 participants
|
3 participants
|
|
Commonly Reported and Notable Adverse Events
Injection-related eyelid swelling
|
2 participants
|
1 participants
|
|
Commonly Reported and Notable Adverse Events
Macular hole
|
0 participants
|
1 participants
|
|
Commonly Reported and Notable Adverse Events
Transient increased intraocular pressure
|
0 participants
|
1 participants
|
|
Commonly Reported and Notable Adverse Events
Chalazion
|
1 participants
|
0 participants
|
|
Commonly Reported and Notable Adverse Events
Stye
|
2 participants
|
0 participants
|
|
Commonly Reported and Notable Adverse Events
Decreased color vision
|
0 participants
|
1 participants
|
|
Commonly Reported and Notable Adverse Events
Foreign Body Sensation
|
1 participants
|
0 participants
|
|
Commonly Reported and Notable Adverse Events
Posterior Vitreous detachment
|
0 participants
|
1 participants
|
|
Commonly Reported and Notable Adverse Events
Retinal Pigment epithelial changes
|
0 participants
|
1 participants
|
|
Commonly Reported and Notable Adverse Events
Worsened Night Vision
|
1 participants
|
0 participants
|
|
Commonly Reported and Notable Adverse Events
Worsened polypoidal choroidal vasculopathy
|
1 participants
|
0 participants
|
|
Commonly Reported and Notable Adverse Events
Worsening of Cataracts
|
1 participants
|
2 participants
|
|
Commonly Reported and Notable Adverse Events
Itchy, watery eyes
|
1 participants
|
2 participants
|
Adverse Events
Ranibizumab 0.5 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Ranibizumab 0.3 mg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ranibizumab 0.5 mg
n=10 participants at risk
Intravitreal Injection of Ranibizumab 0.5 mg
|
Ranibizumab 0.3 mg
n=10 participants at risk
Intravitreal Injection of Ranibizumab 0.5 mg
|
|---|---|---|
|
Eye disorders
Flashes of Light
|
10.0%
1/10 • Number of events 1 • 2 years
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Eye disorders
Worsening of Cataract
|
10.0%
1/10 • Number of events 1 • 2 years
|
20.0%
2/10 • Number of events 3 • 2 years
|
|
Eye disorders
Injection Site Pain
|
20.0%
2/10 • Number of events 4 • 2 years
|
30.0%
3/10 • Number of events 3 • 2 years
|
|
Eye disorders
Itchy, Watery Eyes
|
10.0%
1/10 • Number of events 1 • 2 years
|
20.0%
2/10 • Number of events 4 • 2 years
|
|
Eye disorders
Vitreous Hemorrhage
|
10.0%
1/10 • Number of events 1 • 2 years
|
20.0%
2/10 • Number of events 2 • 2 years
|
|
Eye disorders
Ocular Blurriness
|
20.0%
2/10 • Number of events 6 • 2 years
|
30.0%
3/10 • Number of events 4 • 2 years
|
|
Eye disorders
Macular Hole
|
0.00%
0/10 • 2 years
|
10.0%
1/10 • Number of events 2 • 2 years
|
|
Eye disorders
Increased Intraocular Pressure
|
0.00%
0/10 • 2 years
|
10.0%
1/10 • Number of events 2 • 2 years
|
|
Eye disorders
Retinal Pigment Epithelial Changes
|
0.00%
0/10 • 2 years
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Eye disorders
Chalazion
|
10.0%
1/10 • Number of events 1 • 2 years
|
0.00%
0/10 • 2 years
|
|
Eye disorders
Seeing Dark Spots
|
20.0%
2/10 • Number of events 3 • 2 years
|
20.0%
2/10 • Number of events 2 • 2 years
|
|
Eye disorders
Floaters
|
40.0%
4/10 • Number of events 4 • 2 years
|
10.0%
1/10 • Number of events 2 • 2 years
|
|
Eye disorders
Worsened Visual Acuity
|
20.0%
2/10 • Number of events 3 • 2 years
|
10.0%
1/10 • Number of events 2 • 2 years
|
|
Eye disorders
Eyelid Swelling
|
20.0%
2/10 • Number of events 2 • 2 years
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Eye disorders
Foreign Body Sensation
|
10.0%
1/10 • Number of events 1 • 2 years
|
0.00%
0/10 • 2 years
|
|
Eye disorders
Stye
|
20.0%
2/10 • Number of events 2 • 2 years
|
0.00%
0/10 • 2 years
|
|
Eye disorders
Posterior Vitreous Detachment
|
0.00%
0/10 • 2 years
|
10.0%
1/10 • Number of events 1 • 2 years
|
|
Eye disorders
Spider Webs in Vision
|
10.0%
1/10 • Number of events 1 • 2 years
|
20.0%
2/10 • Number of events 3 • 2 years
|
|
Eye disorders
Wavy Lines
|
10.0%
1/10 • Number of events 1 • 2 years
|
20.0%
2/10 • Number of events 2 • 2 years
|
|
Eye disorders
Worsened PCV
|
10.0%
1/10 • Number of events 1 • 2 years
|
0.00%
0/10 • 2 years
|
|
Eye disorders
Worsened Night Vision
|
10.0%
1/10 • Number of events 1 • 2 years
|
0.00%
0/10 • 2 years
|
|
Eye disorders
Decreased color vision
|
0.00%
0/10 • 2 years
|
10.0%
1/10 • Number of events 1 • 2 years
|
Additional Information
Dr. Dennis M Marcus Principal Investigator
Southeast Retina Center, P.C.
Phone: 706-650-0061
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place