Trial Outcomes & Findings for Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma (NCT NCT01711879)
NCT ID: NCT01711879
Last Updated: 2022-03-18
Results Overview
Assess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the incidence of adverse events
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
2 year
Results posted on
2022-03-18
Participant Flow
Participant milestones
| Measure |
Aflibercept With Laser
A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
|
Aflibercept
2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
|
Overall Study
COMPLETED
|
2
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Aflibercept With Laser
A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
|
Aflibercept
2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Use of Intravitreal Aflibercept Injection for Neovascular Glaucoma
Baseline characteristics by cohort
| Measure |
Aflibercept With Laser
n=3 Participants
A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
Aflibercept: Details covered in arm description
|
Aflibercept
n=4 Participants
2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
Aflibercept: Details covered in arm description
|
Total
n=7 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
56.33 years
STANDARD_DEVIATION 5.69 • n=5 Participants
|
61.5 years
STANDARD_DEVIATION 15.63 • n=7 Participants
|
59.29 years
STANDARD_DEVIATION 11.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearAssess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the incidence of adverse events
Outcome measures
| Measure |
Aflibercept With Laser
n=3 Participants
A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
|
Aflibercept
n=4 Participants
2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
|
|---|---|---|
|
Incidence of Adverse Events
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 2 yearAssess the safety profile of repeated intravitreal aflibercept injections in patients with NVG by evaluating the severity of adverse events
Outcome measures
| Measure |
Aflibercept With Laser
n=3 Participants
A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
|
Aflibercept
n=4 Participants
2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
|
|---|---|---|
|
Severity of Adverse Events
Abcess left thigh · Mild
|
0 Participants
|
1 Participants
|
|
Severity of Adverse Events
Abcess left thigh · Moderate
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
Abcess left thigh · Severe
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
Abcess left thigh · None
|
3 Participants
|
3 Participants
|
|
Severity of Adverse Events
Asthma · Mild
|
0 Participants
|
1 Participants
|
|
Severity of Adverse Events
Asthma · Moderate
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
Asthma · Severe
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
Asthma · None
|
3 Participants
|
3 Participants
|
|
Severity of Adverse Events
Pneumonia · Mild
|
0 Participants
|
1 Participants
|
|
Severity of Adverse Events
Pneumonia · Moderate
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
Pneumonia · Severe
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
Pneumonia · None
|
3 Participants
|
3 Participants
|
|
Severity of Adverse Events
Vitreous hemorrhage · Mild
|
2 Participants
|
0 Participants
|
|
Severity of Adverse Events
Vitreous hemorrhage · Moderate
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
Vitreous hemorrhage · Severe
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
Vitreous hemorrhage · None
|
1 Participants
|
4 Participants
|
|
Severity of Adverse Events
Worsening cataract non-study eye · Mild
|
0 Participants
|
1 Participants
|
|
Severity of Adverse Events
Worsening cataract non-study eye · Moderate
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
Worsening cataract non-study eye · Severe
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
Worsening cataract non-study eye · None
|
3 Participants
|
3 Participants
|
|
Severity of Adverse Events
Worsening Cataract Study eye · Mild
|
1 Participants
|
1 Participants
|
|
Severity of Adverse Events
Worsening Cataract Study eye · Moderate
|
1 Participants
|
0 Participants
|
|
Severity of Adverse Events
Worsening Cataract Study eye · Severe
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
Worsening Cataract Study eye · None
|
1 Participants
|
3 Participants
|
|
Severity of Adverse Events
Diabetes Mellitus · Mild
|
0 Participants
|
1 Participants
|
|
Severity of Adverse Events
Diabetes Mellitus · Moderate
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
Diabetes Mellitus · Severe
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
Diabetes Mellitus · None
|
3 Participants
|
3 Participants
|
|
Severity of Adverse Events
Worsening NVG - non-study eye · Mild
|
0 Participants
|
1 Participants
|
|
Severity of Adverse Events
Worsening NVG - non-study eye · Moderate
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
Worsening NVG - non-study eye · Severe
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
Worsening NVG - non-study eye · None
|
3 Participants
|
3 Participants
|
|
Severity of Adverse Events
Recurrent BCC · Mild
|
0 Participants
|
1 Participants
|
|
Severity of Adverse Events
Recurrent BCC · Moderate
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
Recurrent BCC · Severe
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
Recurrent BCC · None
|
3 Participants
|
3 Participants
|
|
Severity of Adverse Events
progression of gall bladder cancer · Mild
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
progression of gall bladder cancer · Moderate
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
progression of gall bladder cancer · Severe
|
1 Participants
|
0 Participants
|
|
Severity of Adverse Events
progression of gall bladder cancer · None
|
2 Participants
|
4 Participants
|
|
Severity of Adverse Events
worsening of arthritis Right knee · Mild
|
0 Participants
|
1 Participants
|
|
Severity of Adverse Events
worsening of arthritis Right knee · Moderate
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
worsening of arthritis Right knee · Severe
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
worsening of arthritis Right knee · None
|
3 Participants
|
3 Participants
|
|
Severity of Adverse Events
matastatic cancer of liver · Mild
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
matastatic cancer of liver · Moderate
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
matastatic cancer of liver · Severe
|
1 Participants
|
0 Participants
|
|
Severity of Adverse Events
matastatic cancer of liver · None
|
2 Participants
|
4 Participants
|
|
Severity of Adverse Events
shortness of breath · Mild
|
0 Participants
|
1 Participants
|
|
Severity of Adverse Events
shortness of breath · Moderate
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
shortness of breath · Severe
|
0 Participants
|
0 Participants
|
|
Severity of Adverse Events
shortness of breath · None
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: No data was collected or analyzed for this Outcome Measure
Compare between Groups A and B the Rate and extent of resolution of neovascularization in patients with NVG Stages 1 \& 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.
Intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B
Outcome measures
| Measure |
Aflibercept With Laser
n=2 Participants
A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
|
Aflibercept
n=4 Participants
2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
|
|---|---|---|
|
Intraocular Pressure (mmHg) at Baseline
Study Eye Mean IOP(mmHg) at Baseline
|
10 mmHg
Interval 8.0 to 12.0
|
23.5 mmHg
Interval 14.0 to 34.0
|
|
Intraocular Pressure (mmHg) at Baseline
Fellow Eye Mean IOP(mmHg) at Baseline
|
11 mmHg
Interval 8.0 to 14.0
|
22.75 mmHg
Interval 17.0 to 36.0
|
SECONDARY outcome
Timeframe: Week 52Population: One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.
Mean intraocular pressure(mmHg) as measured by Goldmann applanation tonometry between groups A and B
Outcome measures
| Measure |
Aflibercept With Laser
n=2 Participants
A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
|
Aflibercept
n=4 Participants
2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
|
|---|---|---|
|
Intraocular Pressure (mmHg) at Week 52
Study Eye Mean IOP(mmHg) at W52
|
10 mmHg
Interval 8.0 to 12.0
|
15.25 mmHg
Interval 13.0 to 19.0
|
|
Intraocular Pressure (mmHg) at Week 52
Fellow Eye Mean IOP(mmHg) at W52
|
10 mmHg
Interval 8.0 to 12.0
|
14 mmHg
Interval 6.0 to 20.0
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.
Comparison between patients, groups A and B, that lost \> 5 letters on visual acuity
Outcome measures
| Measure |
Aflibercept With Laser
n=3 Participants
A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
|
Aflibercept
n=3 Participants
2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
|
|---|---|---|
|
Number of Patients Losing > 5 Letters on Visual Acuity in Each Group A and Group B
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.
Comparison of patients in each, group A and group B, that gained \> 5 letters on visual acuity
Outcome measures
| Measure |
Aflibercept With Laser
n=3 Participants
A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
|
Aflibercept
n=3 Participants
2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
|
|---|---|---|
|
Number of Patients in Each, Group A and Group B, Gaining > 5 Letters on Visual Acuity
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.
Comparison of visual acuity between groups A and B
Outcome measures
| Measure |
Aflibercept With Laser
n=2 Participants
A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
|
Aflibercept
n=4 Participants
2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
|
|---|---|---|
|
Visual Acuity at Baseline
|
64 Letters
Interval 64.0 to 64.0
|
37.5 Letters
Interval 0.0 to 83.0
|
SECONDARY outcome
Timeframe: Week 52Population: One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.
Comparison of visual acuity at Week 52 between groups A and B
Outcome measures
| Measure |
Aflibercept With Laser
n=2 Participants
A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
|
Aflibercept
n=4 Participants
2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
|
|---|---|---|
|
Visual Acuity at Week 52
Study Eye Mean W52 Number of ETDRS Letters
|
33.5 Letters
Interval 0.0 to 67.0
|
62 Letters
Interval 34.0 to 87.0
|
|
Visual Acuity at Week 52
Fellow Eye Mean W52 Number of ETDRS Letters
|
32 Letters
Interval 0.0 to 64.0
|
46.75 Letters
Interval 0.0 to 84.0
|
SECONDARY outcome
Timeframe: 1 yearPopulation: No data was collected or analyzed for this Outcome Measure during the clinical trial.
Comparison of the Visual field s measured by HVF 24-2 SITA Standards between groups A and B
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 52Population: The database in OCT was corrupted and the data was lost
Evaluation of the Optical Coherence Tomography(OCT) outcomes (average retinal nerve fiber layer(RNFL) and central macular thickness), Compared between groups A and B.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: One participant from group Aflibercept with Laser did not complete analysis due to death. Analysis is limited due to small sample size.
Comparison between groups A and B and the need for surgical intervention in both arms during the follow-up period
Outcome measures
| Measure |
Aflibercept With Laser
n=3 Participants
A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
|
Aflibercept
n=3 Participants
2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
|
|---|---|---|
|
Number of Patients With Need for Surgical Intervention
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 yearComparison between groups A and B for the need of additional IOP lowering medications
Outcome measures
| Measure |
Aflibercept With Laser
n=2 Participants
A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
|
Aflibercept
n=4 Participants
2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
|
|---|---|---|
|
Number of Participants With Need for Additional IOP Lowering Medications
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: NVG Staging not recorded
Comparison of groups A and B and the extent of resolution of neovascularization in patients with NVG Stages 1 \& 2
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 yearPopulation: The OCT database was corrupted and the data was lost
Comparison between groups A and B of the average retinal nerve fiber layer (RNFL) as measured by Optical Coherence Tomography (OCT)
Outcome measures
Outcome data not reported
Adverse Events
Aflibercept With Laser
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Aflibercept
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aflibercept With Laser
n=3 participants at risk
A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
|
Aflibercept
n=4 participants at risk
2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
|
|---|---|---|
|
General disorders
Death
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/4 • 2 years
|
Other adverse events
| Measure |
Aflibercept With Laser
n=3 participants at risk
A single injection of 2mg (0.05ml) intravitreal aflibercept injection at baseline followed by standard of care laser with observation for a total of 52 weeks
|
Aflibercept
n=4 participants at risk
2mg (0.05ml) intravitreal aflibercept injection at baseline followed by two additional injections at 4 weeks and 8 weeks, then every 8 weeks for a total of 52 weeks.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Recurrent BCC
|
0.00%
0/3 • 2 years
|
25.0%
1/4 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Abcess left thigh
|
0.00%
0/3 • 2 years
|
25.0%
1/4 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/3 • 2 years
|
25.0%
1/4 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/3 • 2 years
|
25.0%
1/4 • Number of events 1 • 2 years
|
|
Eye disorders
Vitreous hemmorrhage
|
66.7%
2/3 • Number of events 2 • 2 years
|
0.00%
0/4 • 2 years
|
|
Eye disorders
Worsening cataract non-study eye
|
0.00%
0/3 • 2 years
|
25.0%
1/4 • Number of events 1 • 2 years
|
|
Eye disorders
Worsening Cataract Study eye
|
66.7%
2/3 • Number of events 2 • 2 years
|
25.0%
1/4 • Number of events 1 • 2 years
|
|
Endocrine disorders
Diabetes Mellitus
|
0.00%
0/3 • 2 years
|
25.0%
1/4 • Number of events 1 • 2 years
|
|
Eye disorders
Worsening NVG - non-study eye
|
0.00%
0/3 • 2 years
|
25.0%
1/4 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
0.00%
0/3 • 2 years
|
25.0%
1/4 • Number of events 1 • 2 years
|
|
Musculoskeletal and connective tissue disorders
worsening arthritis right knee
|
0.00%
0/3 • 2 years
|
25.0%
1/4 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
progression of gall bladder cancer
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/4 • 2 years
|
|
Gastrointestinal disorders
metastatic cancer affecting liver
|
33.3%
1/3 • Number of events 1 • 2 years
|
0.00%
0/4 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place