Trial Outcomes & Findings for A Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration (NCT NCT02181517)
NCT ID: NCT02181517
Last Updated: 2016-05-17
Results Overview
BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
COMPLETED
PHASE2
25 participants
Baseline, Week 16
2016-05-17
Participant Flow
Participant milestones
| Measure |
Abicipar Pegol 1 mg
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 2 mg
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
5
|
|
Overall Study
COMPLETED
|
10
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration
Baseline characteristics by cohort
| Measure |
Abicipar Pegol 1 mg
n=10 Participants
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 2 mg
n=10 Participants
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
n=5 Participants
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
≤ 65 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
|
Age, Customized
> 65 years
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
5 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16Population: Modified Intent-to-Treat (mITT) population included all randomized and treated participants with at least 1 follow-up visit.
BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Outcome measures
| Measure |
Abicipar Pegol 1 mg
n=10 Participants
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 2 mg
n=10 Participants
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
n=5 Participants
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
|---|---|---|---|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
Baseline
|
55.2 letters
Standard Deviation 12.97
|
59.0 letters
Standard Deviation 10.36
|
57.6 letters
Standard Deviation 17.04
|
|
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
Change from Baseline at Week 16
|
4.4 letters
Standard Deviation 8.96
|
10.1 letters
Standard Deviation 10.5
|
15.2 letters
Standard Deviation 6.72
|
SECONDARY outcome
Timeframe: Baseline, Week 20Population: mITT population included all randomized and treated participants with at least 1 follow-up visit.
BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Outcome measures
| Measure |
Abicipar Pegol 1 mg
n=10 Participants
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 2 mg
n=10 Participants
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
n=5 Participants
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
|---|---|---|---|
|
Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale
Baseline
|
55.2 letters
Standard Deviation 12.97
|
59.0 letters
Standard Deviation 10.36
|
57.6 letters
Standard Deviation 17.04
|
|
Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale
Change from Baseline at Week 20
|
5.6 letters
Standard Deviation 12.12
|
6.7 letters
Standard Deviation 15.98
|
14.4 letters
Standard Deviation 7.89
|
SECONDARY outcome
Timeframe: Baseline, Week 20Population: mITT population included all randomized and treated participants with at least 1 follow-up visit.
BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Outcome measures
| Measure |
Abicipar Pegol 1 mg
n=10 Participants
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 2 mg
n=10 Participants
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
n=5 Participants
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
|---|---|---|---|
|
Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale
|
30.0 percentage of participants
|
30.0 percentage of participants
|
60.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 20Population: mITT population included all randomized and treated participants with at least 1 follow-up visit.
BCVA is measured using an eye chart and is reported as the number of letters read correctly using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Outcome measures
| Measure |
Abicipar Pegol 1 mg
n=10 Participants
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 2 mg
n=10 Participants
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
n=5 Participants
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
|---|---|---|---|
|
Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale
|
40.0 percentage of participants
|
40.0 percentage of participants
|
60.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 16, Week 20Population: mITT population included all randomized and treated participants with at least 1 follow-up visit.
CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
Abicipar Pegol 1 mg
n=10 Participants
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 2 mg
n=10 Participants
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
n=5 Participants
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
|---|---|---|---|
|
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Baseline
|
443.8 microns
Standard Deviation 107.32
|
383.8 microns
Standard Deviation 146.90
|
348.8 microns
Standard Deviation 33.26
|
|
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Change from Baseline at Week 16
|
-106.5 microns
Standard Deviation 128.50
|
-112.8 microns
Standard Deviation 169.75
|
-124.4 microns
Standard Deviation 49.51
|
|
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Change from Baseline at Week 20
|
-78.2 microns
Standard Deviation 104.73
|
-90.3 microns
Standard Deviation 178.22
|
-110.4 microns
Standard Deviation 45.87
|
Adverse Events
Abicipar Pegol 1 mg
Abicipar Pegol 2 mg
Ranibizumab 0.5 mg
Serious adverse events
| Measure |
Abicipar Pegol 1 mg
n=10 participants at risk
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 2 mg
n=10 participants at risk
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
n=5 participants at risk
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/10
|
10.0%
1/10
|
0.00%
0/5
|
|
Infections and infestations
Escherichia bacteremia
|
0.00%
0/10
|
10.0%
1/10
|
0.00%
0/5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
10.0%
1/10
|
0.00%
0/10
|
0.00%
0/5
|
Other adverse events
| Measure |
Abicipar Pegol 1 mg
n=10 participants at risk
Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Abicipar Pegol 2 mg
n=10 participants at risk
Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
|
Ranibizumab 0.5 mg
n=5 participants at risk
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
|
|---|---|---|---|
|
Eye disorders
Dry eye
|
10.0%
1/10
|
10.0%
1/10
|
0.00%
0/5
|
|
Eye disorders
Eye pain
|
0.00%
0/10
|
10.0%
1/10
|
20.0%
1/5
|
|
General disorders
Oedema peripheral
|
0.00%
0/10
|
10.0%
1/10
|
20.0%
1/5
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/10
|
10.0%
1/10
|
0.00%
0/5
|
|
Infections and infestations
Influenza
|
0.00%
0/10
|
10.0%
1/10
|
0.00%
0/5
|
|
Investigations
Liver function test abnormal
|
0.00%
0/10
|
10.0%
1/10
|
0.00%
0/5
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/10
|
10.0%
1/10
|
0.00%
0/5
|
|
Eye disorders
Uveitis
|
0.00%
0/10
|
10.0%
1/10
|
0.00%
0/5
|
|
Eye disorders
Vitritis
|
0.00%
0/10
|
10.0%
1/10
|
0.00%
0/5
|
|
Eye disorders
Iridocyclitis
|
10.0%
1/10
|
0.00%
0/10
|
0.00%
0/5
|
|
Eye disorders
Punctate keratitis
|
10.0%
1/10
|
0.00%
0/10
|
0.00%
0/5
|
|
Eye disorders
Retinal haemorrhage
|
10.0%
1/10
|
0.00%
0/10
|
0.00%
0/5
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10
|
0.00%
0/10
|
0.00%
0/5
|
|
Infections and infestations
Urinary tract infection
|
10.0%
1/10
|
0.00%
0/10
|
0.00%
0/5
|
|
Eye disorders
Visual acuity reduced
|
10.0%
1/10
|
0.00%
0/10
|
0.00%
0/5
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/10
|
0.00%
0/10
|
20.0%
1/5
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/10
|
0.00%
0/10
|
20.0%
1/5
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/10
|
0.00%
0/10
|
20.0%
1/5
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/10
|
0.00%
0/10
|
20.0%
1/5
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/10
|
0.00%
0/10
|
20.0%
1/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER