Trial Outcomes & Findings for ProspectiveTrial of Proton Beam Combined With Anti-VEGF Therapy for Exudative Age-related Macular Degeneration (AMD) (NCT NCT01213082)
NCT ID: NCT01213082
Last Updated: 2018-07-17
Results Overview
vision loss of 3 or more lines associated with radiation retinopathy or papillopathy
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
34 participants
Primary outcome timeframe
Month 24
Results posted on
2018-07-17
Participant Flow
Participant milestones
| Measure |
24GyE + Anti-VEGF
24GyE proton and Anti-VEGF: 24GyE proton beam will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
|
16GyE + Anti-VEGF
16GyE and anti-VEGF: 16GyE of Proton Beam Irradiation will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
|
Sham Irradiation + Anti-VEGF
Sham Irradiation and anti-VEGF: 2 Sessions of Sham Proton Beam Irradiation 24 hrs apart administered 2 to 6 weeks after intravitreal anti-VEGF therapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
11
|
|
Overall Study
COMPLETED
|
6
|
4
|
6
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
5
|
Reasons for withdrawal
| Measure |
24GyE + Anti-VEGF
24GyE proton and Anti-VEGF: 24GyE proton beam will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
|
16GyE + Anti-VEGF
16GyE and anti-VEGF: 16GyE of Proton Beam Irradiation will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
|
Sham Irradiation + Anti-VEGF
Sham Irradiation and anti-VEGF: 2 Sessions of Sham Proton Beam Irradiation 24 hrs apart administered 2 to 6 weeks after intravitreal anti-VEGF therapy
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
7
|
4
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
Baseline Characteristics
ProspectiveTrial of Proton Beam Combined With Anti-VEGF Therapy for Exudative Age-related Macular Degeneration (AMD)
Baseline characteristics by cohort
| Measure |
24GyE + Anti-VEGF
n=12 Participants
24GyE proton and Anti-VEGF: 24GyE proton beam will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
|
16GyE + Anti-VEGF
n=11 Participants
16GyE and anti-VEGF: 16GyE of Proton Beam Irradiation will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
|
Sham Irradiation + Anti-VEGF
n=11 Participants
Sham Irradiation and anti-VEGF: 2 Sessions of Sham Proton Beam Irradiation 24 hrs apart administered 2 to 6 weeks after intravitreal anti-VEGF therapy
|
Total
n=34 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
11 participants
n=5 Participants
|
34 participants
n=4 Participants
|
|
best corrected visual acuity
|
0.72 logMAR BCVA
STANDARD_DEVIATION 0.39 • n=5 Participants
|
0.59 logMAR BCVA
STANDARD_DEVIATION 0.51 • n=7 Participants
|
0.55 logMAR BCVA
STANDARD_DEVIATION 0.18 • n=5 Participants
|
0.62 logMAR BCVA
STANDARD_DEVIATION 0.38 • n=4 Participants
|
PRIMARY outcome
Timeframe: Month 24vision loss of 3 or more lines associated with radiation retinopathy or papillopathy
Outcome measures
| Measure |
24GyE PBT
n=6 Participants
intravitreal anti-VEGF combined with 24GyE PBT for exudative AMD
|
16GyE PBT
n=4 Participants
intravitreal anti-VEGF combined with 16GyE PBT for exudative AMD
|
Sham Radiation
n=6 Participants
intravitreal anti-VEGF combined with sham PBT for exudative AMD
|
|---|---|---|---|
|
Percent of Eyes With Severe Ocular Adverse
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Month 24efficacy measure
Outcome measures
| Measure |
24GyE PBT
n=6 Participants
intravitreal anti-VEGF combined with 24GyE PBT for exudative AMD
|
16GyE PBT
n=4 Participants
intravitreal anti-VEGF combined with 16GyE PBT for exudative AMD
|
Sham Radiation
n=6 Participants
intravitreal anti-VEGF combined with sham PBT for exudative AMD
|
|---|---|---|---|
|
Number of Anti-VEGF Injections Administered
|
4.67 number of anti-VEGF injections per eye
Standard Deviation 1.9
|
7.25 number of anti-VEGF injections per eye
Standard Deviation 2.1
|
9.67 number of anti-VEGF injections per eye
Standard Deviation 3.5
|
Adverse Events
24GyE + Anti-VEGF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
16GyE + Anti-VEGF
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham Irradiation + Anti-VEGF
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
24GyE + Anti-VEGF
n=6 participants at risk
24GyE proton and Anti-VEGF: 24GyE proton beam will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
|
16GyE + Anti-VEGF
n=4 participants at risk
16GyE and anti-VEGF: 16GyE of Proton Beam Irradiation will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
|
Sham Irradiation + Anti-VEGF
n=6 participants at risk
Sham Irradiation and anti-VEGF: 2 Sessions of Sham Proton Beam Irradiation 24 hrs apart administered 2 to 6 weeks after intravitreal anti-VEGF therapy
|
|---|---|---|---|
|
Eye disorders
Mild retinal vasculopathy possible radiation retinopathy
|
0.00%
0/6 • 24 months
|
25.0%
1/4 • Number of events 1 • 24 months
|
33.3%
2/6 • Number of events 2 • 24 months
|
|
Eye disorders
cataract progression due to radiation
|
0.00%
0/6 • 24 months
|
0.00%
0/4 • 24 months
|
0.00%
0/6 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place