Trial Outcomes & Findings for Prevention of Macular Edema In Patients With Diabetic Retinopathy Undergoing Cataract Surgery (NCT NCT01988246)
NCT ID: NCT01988246
Last Updated: 2020-05-22
Results Overview
Number of participants with ocular and non-ocular adverse events (AEs) in both treatment arms.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Day 90
Results posted on
2020-05-22
Participant Flow
Participant milestones
| Measure |
Sham Injection
Patients will be sequentially randomized to treatment with a "sham" injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.
Sham: Sham injection. No actual injection. No medication is used.
|
Intravitreal Aflibercept Injection
Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery. This will be administered post cataract excision by the Principal Investigator. The patient will be masked as to which Arm they are assigned.
Aflibercept: Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection.
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prevention of Macular Edema In Patients With Diabetic Retinopathy Undergoing Cataract Surgery
Baseline characteristics by cohort
| Measure |
Sham Injection
n=15 Participants
Patients will be sequentially randomized to treatment with a "sham" injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.
Sham: Sham injection. No actual injection. No medication is used.
|
Intravitreal Aflibercept Injection
n=15 Participants
Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery. This will be administered post cataract excision by the Principal Investigator. The patient will be masked as to which Arm they are assigned.
Aflibercept: Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
66 years
n=5 Participants
|
66 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 90Number of participants with ocular and non-ocular adverse events (AEs) in both treatment arms.
Outcome measures
| Measure |
Sham Injection
n=15 Participants
Patients will be sequentially randomized to treatment with a "sham" injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.
Sham: Sham injection. No actual injection. No medication is used.
|
Intravitreal Aflibercept Injection
n=15 Participants
Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery. This will be administered post cataract excision by the Principal Investigator. The patient will be masked as to which Arm they are assigned.
Aflibercept: Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection.
|
|---|---|---|
|
Number of Participants With Ocular and Non-Ocular Adverse Events
At least 1 Ocular Adverse Event
|
11 Participants
|
10 Participants
|
|
Number of Participants With Ocular and Non-Ocular Adverse Events
At least 1 Non-Ocular Adverse Event
|
5 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 90Change from baseline in best-corrected visual acuity (BCVA) score and BCVA score at Day 90 as measured by ETDRS (early treatment diabetic retinopathy study) There were no sub scales used. These are common methods for ophthalmology studies to report their findings. The scale provided is the Electronic-Early Treatment in Diabetic Retinopathy Scale (E-ETDRS) best corrected visual acuity scale. Values that are higher are considered better and values that are lower are considered worse. Minimum E-ETDRS was 24 E-ETDRS letters and maximum E-ETDRS was 80 E-ETDRS letters.
Outcome measures
| Measure |
Sham Injection
n=15 Participants
Patients will be sequentially randomized to treatment with a "sham" injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.
Sham: Sham injection. No actual injection. No medication is used.
|
Intravitreal Aflibercept Injection
n=15 Participants
Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery. This will be administered post cataract excision by the Principal Investigator. The patient will be masked as to which Arm they are assigned.
Aflibercept: Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection.
|
|---|---|---|
|
Change From Baseline in Best-Corrected Visual Acuity (BCVA) Score
|
8.52 Number of Letters Read Correctly
Interval 4.26 to 12.78
|
9.88 Number of Letters Read Correctly
Interval 5.54 to 14.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 90The change in macular edema as measured by SD-OCT (spectral domain ocular coherence tomography)at 90 days
Outcome measures
| Measure |
Sham Injection
n=15 Participants
Patients will be sequentially randomized to treatment with a "sham" injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.
Sham: Sham injection. No actual injection. No medication is used.
|
Intravitreal Aflibercept Injection
n=15 Participants
Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery. This will be administered post cataract excision by the Principal Investigator. The patient will be masked as to which Arm they are assigned.
Aflibercept: Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection.
|
|---|---|---|
|
Change From Baseline in Retinal Thickness
|
50.32 Microns
Interval 14.49 to 86.15
|
18.48 Microns
Interval 0.87 to 36.09
|
Adverse Events
Sham Injection
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Intravitreal Aflibercept Injection
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sham Injection
n=15 participants at risk
Patients will be sequentially randomized to treatment with a "sham" injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.
Sham: Sham injection. No actual injection. No medication is used.
|
Intravitreal Aflibercept Injection
n=15 participants at risk
Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery. This will be administered post cataract excision by the Principal Investigator. The patient will be masked as to which Arm they are assigned.
Aflibercept: Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection.
|
|---|---|---|
|
Eye disorders
Paracentesis
|
0.00%
0/15 • Up to 90 days following each surgery
|
13.3%
2/15 • Up to 90 days following each surgery
|
|
Gastrointestinal disorders
Cough/Vomiting
|
0.00%
0/15 • Up to 90 days following each surgery
|
6.7%
1/15 • Up to 90 days following each surgery
|
|
Skin and subcutaneous tissue disorders
Rash and Swelling on Limbs
|
13.3%
2/15 • Up to 90 days following each surgery
|
0.00%
0/15 • Up to 90 days following each surgery
|
Other adverse events
| Measure |
Sham Injection
n=15 participants at risk
Patients will be sequentially randomized to treatment with a "sham" injection at the time of surgery. The sham injection is accomplished by pressing an empty syringe against the eye wall without penetration. This will be administered post cataract excision by the Prinicipal Investigator. The patient will be masked as to which Arm they are assigned.
Sham: Sham injection. No actual injection. No medication is used.
|
Intravitreal Aflibercept Injection
n=15 participants at risk
Patients will be sequentially randomized to treatment with Aflibercept 2 mg via intravitreal injection (0.05 mL or 50 microliters) at the time of surgery. This will be administered post cataract excision by the Principal Investigator. The patient will be masked as to which Arm they are assigned.
Aflibercept: Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection.
|
|---|---|---|
|
Eye disorders
Foreign Body Sensation
|
20.0%
3/15 • Up to 90 days following each surgery
|
20.0%
3/15 • Up to 90 days following each surgery
|
|
Eye disorders
Corneal Edema
|
0.00%
0/15 • Up to 90 days following each surgery
|
6.7%
1/15 • Up to 90 days following each surgery
|
|
Eye disorders
Eye Irritation/Pain
|
13.3%
2/15 • Up to 90 days following each surgery
|
13.3%
2/15 • Up to 90 days following each surgery
|
|
Eye disorders
Eye Itching
|
6.7%
1/15 • Up to 90 days following each surgery
|
13.3%
2/15 • Up to 90 days following each surgery
|
|
Eye disorders
Lacrimation Increased
|
6.7%
1/15 • Up to 90 days following each surgery
|
6.7%
1/15 • Up to 90 days following each surgery
|
|
Eye disorders
Blurred Vision
|
26.7%
4/15 • Up to 90 days following each surgery
|
13.3%
2/15 • Up to 90 days following each surgery
|
|
Eye disorders
Photophobia
|
20.0%
3/15 • Up to 90 days following each surgery
|
0.00%
0/15 • Up to 90 days following each surgery
|
|
Eye disorders
Floaters
|
26.7%
4/15 • Up to 90 days following each surgery
|
13.3%
2/15 • Up to 90 days following each surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60