Trial Outcomes & Findings for Extension Study to Gather Data on Effect of Macugen on the Corneal Endothelium (NCT NCT01573572)
NCT ID: NCT01573572
Last Updated: 2021-01-08
Results Overview
The effect on the corneal endothelium will be assessed by specular microscopy, by assessing mean cell density change from baseline. This is to evaluate that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
131 participants
Primary outcome timeframe
Baseline, Week 54
Results posted on
2021-01-08
Participant Flow
Participant milestones
| Measure |
Intravitreal Injections of Macugen
pegaptanib sodium injection: 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks
|
|---|---|
|
Overall Study
STARTED
|
131
|
|
Overall Study
COMPLETED
|
103
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Extension Study to Gather Data on Effect of Macugen on the Corneal Endothelium
Baseline characteristics by cohort
| Measure |
Intravitreal Injections of Macugen
n=131 Participants
pegaptanib sodium injection: 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks
|
|---|---|
|
Age, Continuous
|
71.0 years
STANDARD_DEVIATION 10.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
40 Participants
n=5 Participants
|
|
Designated eye
Right eye
|
69 Participants
n=5 Participants
|
|
Designated eye
Left eye
|
62 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 54Population: Participants with cell density assessments at both baseline and Week 54.
The effect on the corneal endothelium will be assessed by specular microscopy, by assessing mean cell density change from baseline. This is to evaluate that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen.
Outcome measures
| Measure |
Intravitreal Injections of Macugen
n=87 Participants
pegaptanib sodium injection: 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks
|
|---|---|
|
Change From Baseline in Mean Endothelial Cell Density
|
-35.86 cells/millimeter squared
Standard Deviation 175.544
|
Adverse Events
Intravitreal Injections of Macugen
Serious events: 12 serious events
Other events: 19 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Intravitreal Injections of Macugen
n=131 participants at risk
pegaptanib sodium injection: 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks
|
|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
1.5%
2/131 • 54 weeks
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
2/131 • 54 weeks
|
|
General disorders
Chest pain
|
1.5%
2/131 • 54 weeks
|
|
Vascular disorders
Blood pressure inadequately controlled
|
1.5%
2/131 • 54 weeks
|
|
Cardiac disorders
Bradycardia
|
0.76%
1/131 • 54 weeks
|
|
Cardiac disorders
Cardiac arrest
|
0.76%
1/131 • 54 weeks
|
|
Infections and infestations
Pneumonia
|
0.76%
1/131 • 54 weeks
|
|
Renal and urinary disorders
Urinary tract infection
|
0.76%
1/131 • 54 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.76%
1/131 • 54 weeks
|
|
Investigations
Hypernatraemia
|
0.76%
1/131 • 54 weeks
|
|
Eye disorders
Glaucoma
|
0.76%
1/131 • 54 weeks
|
|
Eye disorders
Visual acuity reduced
|
0.76%
1/131 • 54 weeks
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.76%
1/131 • 54 weeks
|
|
Gastrointestinal disorders
Gastritis
|
0.76%
1/131 • 54 weeks
|
|
Gastrointestinal disorders
Pancreatic carcinoma
|
0.76%
1/131 • 54 weeks
|
|
Vascular disorders
Cerebrovascular accident
|
0.76%
1/131 • 54 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.76%
1/131 • 54 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.76%
1/131 • 54 weeks
|
Other adverse events
| Measure |
Intravitreal Injections of Macugen
n=131 participants at risk
pegaptanib sodium injection: 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks
|
|---|---|
|
Eye disorders
Eye pain
|
7.6%
10/131 • 54 weeks
|
|
Eye disorders
Conjunctival haemorrhage
|
6.9%
9/131 • 54 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Contact sponsor directly for details.
- Publication restrictions are in place
Restriction type: OTHER