Trial Outcomes & Findings for IAI for Persistent DME After Treatment With Bevacizumab And Ranibizumab (NCT NCT03340610)
NCT ID: NCT03340610
Last Updated: 2019-05-24
Results Overview
Reduction in macular edema measured as * Proportion of eyes with baseline SD OCT CST \>350 um demonstrating \>15% reduction at week 52 from baseline * Proportion of eyes that demonstrate SD OCT CST \<305um (males) and \<290 um (females) at week 52 from baseline
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
52 weeks from baseline
Results posted on
2019-05-24
Participant Flow
Participant milestones
| Measure |
Phase 4 Prospective, Nonrandomized, Open Label, Interventional
Evaluating the efficacy of Alflibercept Injections in DME Following Treatment With Bevacizumab and Ranibizumab
Alflibercept: Intravitreal Injection
Study eyes will receive 5 required initial monthly IAI doses of 2 mg followed by 2q8 IAI for a total of 52 weeks.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
IAI for Persistent DME After Treatment With Bevacizumab And Ranibizumab
Baseline characteristics by cohort
| Measure |
Open Label Single Arm Trial
n=30 Participants
Evaluating the efficacy of Alflibercept Injections in DME Following Treatment With Bevacizumab and Ranibizumab
Alflibercept: Intravitreal Injection
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=93 Participants
|
|
Age, Continuous
|
63 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=93 Participants
|
|
Insulin Dependency (Independent/Dependent)
Independent
|
13 Participants
n=93 Participants
|
|
Insulin Dependency (Independent/Dependent)
Dependent
|
17 Participants
n=93 Participants
|
|
Diabetic Retinopathy (Proliferative/Non-Proliferative)
Proliferative
|
11 Participants
n=93 Participants
|
|
Diabetic Retinopathy (Proliferative/Non-Proliferative)
Non-Proliferative
|
19 Participants
n=93 Participants
|
|
Average Anti-VEGF Injections Received Prior to Baseline
|
14.5 injections
n=93 Participants
|
|
Baseline Visual Acuity
|
64 letters
n=93 Participants
|
|
Baseline Optical Coherence Tomography (OCT) Central Subfield Thickness (CST)
|
459 microns
n=93 Participants
|
|
Eyes with Prior Macular Laser
|
7 Participants
n=93 Participants
|
|
Eyes with Prior Panretinal Photocoagulation (PRP)
|
9 Eyes
n=93 Participants
|
PRIMARY outcome
Timeframe: 52 weeks from baselinePopulation: Answered to the query of PRS review
Reduction in macular edema measured as * Proportion of eyes with baseline SD OCT CST \>350 um demonstrating \>15% reduction at week 52 from baseline * Proportion of eyes that demonstrate SD OCT CST \<305um (males) and \<290 um (females) at week 52 from baseline
Outcome measures
| Measure |
Open Label Single Arm Trial
n=30 Participants
Evaluating the efficacy of Alflibercept Injections in DME Following Treatment With Bevacizumab and Ranibizumab
Alflibercept: Intravitreal Injection
|
|---|---|
|
Reduction in Macular Edema
OCT CST >350 um demonstrating >15% reduction
|
15 Participants
|
|
Reduction in Macular Edema
OCT CST <305um (males)
|
8 Participants
|
|
Reduction in Macular Edema
OCT CST<290 um (females)
|
4 Participants
|
Adverse Events
Phase 4 Prospective, Nonrandomized, Open Label, Interventional
Serious events: 5 serious events
Other events: 26 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 4 Prospective, Nonrandomized, Open Label, Interventional
n=30 participants at risk
Evaluating the efficacy of Alflibercept Injections in DME Following Treatment With Bevacizumab and Ranibizumab
Alflibercept: Intravitreal Injection
Study eyes will receive 5 required initial monthly IAI doses of 2 mg followed by 2q8 IAI for a total of 52 weeks.
|
|---|---|
|
Metabolism and nutrition disorders
Hospitalization- Low electrolytes
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Cardiac disorders
Death
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Kidney Failure
|
3.3%
1/30 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Phase 4 Prospective, Nonrandomized, Open Label, Interventional
n=30 participants at risk
Evaluating the efficacy of Alflibercept Injections in DME Following Treatment With Bevacizumab and Ranibizumab
Alflibercept: Intravitreal Injection
Study eyes will receive 5 required initial monthly IAI doses of 2 mg followed by 2q8 IAI for a total of 52 weeks.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
6.7%
2/30 • Number of events 2 • 1 year
|
|
Infections and infestations
Common Cold
|
30.0%
9/30 • Number of events 9 • 1 year
|
|
Cardiac disorders
Cardiovascular events
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Infections and infestations
Bladder Infection
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Hernia
|
10.0%
3/30 • Number of events 3 • 1 year
|
|
Infections and infestations
Blepharitis
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Eye disorders
Subconjunctival Hemorrhage
|
6.7%
2/30 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Cataract Extraction
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Yag Laser Capsulotomy
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Eye disorders
Trace Epiretinal Membrane
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Eye disorders
Blurry Vision
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Kidney/Liver Conditions
|
20.0%
6/30 • Number of events 6 • 1 year
|
|
Nervous system disorders
Neurotoxicity
|
3.3%
1/30 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Volume Overload
|
3.3%
1/30 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place