A Phase 2 interventional study of abicipar pegol and ranibizumab in Macular Degeneration, sponsored by Allergan. Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2016-05-17.
Sponsored by Allergan · Phase 2, Interventional, and Treatment
This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 25 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: abicipar pegol · Other: sham procedure
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.
Drug: abicipar pegol · Other: sham procedure
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
Drug: ranibizumab
Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
Also known as: Lucentis®
Sham procedure to the study eye at weeks 12 and 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
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.
Time frame: Baseline, Week 16
Change From Baseline in BCVA in the Study Eye at Week 20 Using the ETDRS Scale
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.
Time frame: Baseline, Week 20
Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale
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.
Time frame: Baseline, Week 20
Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale
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.
Time frame: Baseline, Week 20
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
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.
Time frame: Baseline, Week 16, Week 20
| Milestone | Abicipar Pegol 1 mg | Abicipar Pegol 2 mg | Ranibizumab 0.5 mg |
|---|---|---|---|
| Started | 10 | 10 | 5 |
| Completed | 10 | 10 | 5 |
| Not completed | 0 | 0 | 0 |
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.
| letters | Abicipar Pegol 1 mg | Abicipar Pegol 2 mg | Ranibizumab 0.5 mg |
|---|---|---|---|
| Baseline | 55.2 ± 12.97 | 59.0 ± 10.36 | 57.6 ± 17.04 |
| Change from Baseline at Week 16 | 4.4 ± 8.96 | 10.1 ± 10.5 | 15.2 ± 6.72 |
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.
| letters | Abicipar Pegol 1 mg | Abicipar Pegol 2 mg | Ranibizumab 0.5 mg |
|---|---|---|---|
| Baseline | 55.2 ± 12.97 | 59.0 ± 10.36 | 57.6 ± 17.04 |
| Change from Baseline at Week 20 | 5.6 ± 12.12 | 6.7 ± 15.98 | 14.4 ± 7.89 |
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.
| percentage of participants | Abicipar Pegol 1 mg | Abicipar Pegol 2 mg | Ranibizumab 0.5 mg |
|---|---|---|---|
| Percentage of Patients With a BCVA Gain of 15 or More Letters in the Study Eye Using the ETDRS Scale | 30.0 | 30.0 | 60.0 |
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.
| percentage of participants | Abicipar Pegol 1 mg | Abicipar Pegol 2 mg | Ranibizumab 0.5 mg |
|---|---|---|---|
| Percentage of Patients With a BCVA Gain of 10 or More Letters in the Study Eye Using the ETDRS Scale | 40.0 | 40.0 | 60.0 |
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.
| microns | Abicipar Pegol 1 mg | Abicipar Pegol 2 mg | Ranibizumab 0.5 mg |
|---|---|---|---|
| Baseline | 443.8 ± 107.32 | 383.8 ± 146.90 | 348.8 ± 33.26 |
| Change from Baseline at Week 16 | -106.5 ± 128.50 | -112.8 ± 169.75 | -124.4 ± 49.51 |
| Change from Baseline at Week 20 | -78.2 ± 104.73 | -90.3 ± 178.22 | -110.4 ± 45.87 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Abicipar Pegol 1 mg | — | 1/10 (10%) | 5/10 (50%) |
| Abicipar Pegol 2 mg | — | 1/10 (10%) | 6/10 (60%) |
| Ranibizumab 0.5 mg | — | 0/5 (0%) | 2/5 (40%) |
| Event | Abicipar Pegol 1 mg | Abicipar Pegol 2 mg | Ranibizumab 0.5 mg |
|---|---|---|---|
| PneumoniaInfections and infestations | 0/10 | 1/10 | 0/5 |
| Escherichia bacteremiaInfections and infestations | 0/10 | 1/10 | 0/5 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/10 | 0/10 | 0/5 |
| Event | Abicipar Pegol 1 mg | Abicipar Pegol 2 mg | Ranibizumab 0.5 mg |
|---|---|---|---|
| Eye painEye disorders | 0/10 | 1/10 | 1/5 |
| Oedema peripheralGeneral disorders | 0/10 | 1/10 | 1/5 |
| Aortic stenosisVascular disorders | 0/10 | 0/10 | 1/5 |
| Conjunctival haemorrhageEye disorders | 0/10 | 0/10 | 1/5 |
| Corneal abrasionInjury, poisoning and procedural complications | 0/10 | 0/10 | 1/5 |
| Pulmonary hypertensionRespiratory, thoracic and mediastinal disorders | 0/10 | 0/10 | 1/5 |
| Tricuspid valve incompetenceCardiac disorders | 0/10 | 0/10 | 1/5 |
| Dry eyeEye disorders | 1/10 | 1/10 | 0/5 |
| Drug hypersensitivityImmune system disorders | 0/10 | 1/10 | 0/5 |
| InfluenzaInfections and infestations | 0/10 | 1/10 | 0/5 |
| Age, Customized(participants) | Abicipar Pegol 1 mg | Abicipar Pegol 2 mg | Ranibizumab 0.5 mg | Total |
|---|---|---|---|---|
| ≤ 65 years | 0 | 0 | 0 | 0 |
| > 65 years | 10 | 10 | 5 | 25 |
| Sex: Female, Male(Participants) | Abicipar Pegol 1 mg | Abicipar Pegol 2 mg | Ranibizumab 0.5 mg | Total |
|---|---|---|---|---|
| Female | 9 | 7 | 4 | 20 |
| Male | 1 | 3 | 1 | 5 |
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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