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NCT02462486

Safety and Efficacy of Abicipar Pegol in Participants With Neovascular Age-related Macular Degeneration

Completed Phase 3 Results posted Last updated 30 July 2020
What this trial tests

Phase 3 trial testing Abicipar Pegol in Macular Degeneration in 949 participants. Completed in 6 June 2019.

Timeline
25 June 2015
Primary endpoint
12 April 2018
6 June 2019

Quick facts

Lead sponsorAllergan
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment949
Start date25 June 2015
Primary completion12 April 2018
Estimated completion6 June 2019
Sites187 locations across Denmark, Italy, Japan, Netherlands, Russia, South Africa, Peru, Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

Allergan — full company profile →

Who can join

50 and older, any sex, with Macular Degeneration. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Stable Vision at Week 52 Primary · Baseline to Week 52

Stable vision was defined as vision loss of fewer than 15 letters in Best-corrected Visual Acuity (BCVA) from baseline. 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. The percentage of participants with a BCVA loss of fewer than 15 letters are reported. Study eye was defined as the eye that m

GroupValue95% CI
Abicipar Pegol 2 mg (2Q8)94.8
Abicipar Pegol 2 mg (2Q12)91.3
Ranibizumab (rQ4)96.0
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) in the Study Eye at Week 52 Secondary · Baseline to Week 52

BCVA was 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. Mixed-effect model for repeated measures (MMRM) analysis was used. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA v

GroupValue95% CI
Abicipar Pegol 2 mg (2Q8)8.3± 14.3
Abicipar Pegol 2 mg (2Q12)7.3± 13.8
Ranibizumab (rQ4)8.3± 11.8
Mean Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye at Week 52 Secondary · Baseline to Week 52

CRT was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system that provides high-resolution imaging sections of the retina. SD-OCT is performed in the study eye after pupil dilation. A negative change from Baseline indicates improvement and a positive change from baseline indicates worsening. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the eye with worse BCVA at baseline (Day 1) was selected. If BCVA values for both eyes were identical then participant had to select the non-domin

GroupValue95% CI
Abicipar Pegol 2 mg (2Q8)-146.8± 118.1
Abicipar Pegol 2 mg (2Q12)-141.7± 127.1
Ranibizumab (rQ4)-147.1± 126.2
Percentage of Participants With BCVA Gain of More Than 15 Letters From Baseline in the Study Eye at Week 52 Secondary · Baseline to Week 52

BCVA is measured using an eye chart and is reported as the number of letters read correctly using the Early Treatment of Diabetic Retinopathy Study (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. The percentage of participants with a BCVA gain of more than 15 letters are noted. Study eye is defined as the eye that meets the entry criteria. If both the eyes met all of the entry criteria, the

GroupValue95% CI
Abicipar Pegol 2 mg (2Q8)28.2
Abicipar Pegol 2 mg (2Q12)24.4
Ranibizumab (rQ4)26.7
Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score at Week 52 Secondary · Baseline to Week 52

NEI-VFQ-25 consists of 25 vision-targeted questions that represent 11 vision-related quality of life subscales and one general health item. Responses of individual participants were recorded as scores that ranged between 0 (worst) to 100 (best vision related function) with higher scale indicating better vision. Overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye: eye that meets entry criteria. If both eyes met all of entry cri

GroupValue95% CI
Abicipar Pegol 2 mg (2Q8)2.8± 0.7
Abicipar Pegol 2 mg (2Q12)2.4± 0.7
Ranibizumab (rQ4)4.4± 0.7

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first dose up to last dose (Up to Week 104). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Abicipar Pegol 2 mg (2Q8)
Serious: 94/313 (30%)
Deaths: 11/313
Abicipar Pegol 2 mg (2Q12)
Serious: 83/314 (26%)
Deaths: 6/314
Ranibizumab (rQ4)
Serious: 78/315 (25%)
Deaths: 7/315

Serious adverse events (249 terms)

ReactionSystemAbicipar Pegol 2 mg (2Q8)Abicipar Pegol 2 mg (2Q12)Ranibizumab (rQ4)
PneumoniaInfections and infestations
UveitisEye disorders
Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac failure congestiveCardiac disorders
Atrial fibrillationCardiac disorders
Retinal haemorrhageEye disorders
EndophthalmitisInfections and infestations
Myocardial infarctionCardiac disorders
Retinal vasculitisEye disorders
VitritisEye disorders
Angina pectorisCardiac disorders
Retinal detachmentEye disorders
CataractEye disorders
Visual acuity reducedEye disorders
BronchitisInfections and infestations
FallInjury, poisoning and procedural complications
Transient ischaemic attackNervous system disorders
Cerebrovascular accidentNervous system disorders
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders
Coronary artery diseaseCardiac disorders
ArrhythmiaCardiac disorders
BradycardiaCardiac disorders
Cardiac failureCardiac disorders
Myocardial ischaemiaCardiac disorders
Vitreous haemorrhageEye disorders
Other adverse events (14 terms — click to expand)

ReactionSystemAbicipar Pegol 2 mg (2Q8)Abicipar Pegol 2 mg (2Q12)Ranibizumab (rQ4)
NasopharyngitisInfections and infestations
Eye painEye disorders
Vitreous floatersEye disorders
Conjunctival haemorrhageEye disorders
Intraocular pressure increasedInvestigations
Neovascular age-related macular degenerationEye disorders
Conjunctival hyperaemiaEye disorders
InfluenzaInfections and infestations
Urinary tract infectionInfections and infestations
FallInjury, poisoning and procedural complications
HypertensionVascular disorders
HeadacheNervous system disorders
Vitreous detachmentEye disorders
Visual acuity reducedEye disorders

Most-reported serious reactions: Pneumonia, Uveitis, Basal cell carcinoma, Cardiac failure congestive, Atrial fibrillation, Retinal haemorrhage, Endophthalmitis, Myocardial infarction.

Data from ClinicalTrials.gov NCT02462486 adverse events section.

Sponsor's own description

This is a safety and efficacy study of abicipar pegol in participants with neovascular age-related macular degeneration.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Diabetic vascular diseases: molecular mechanisms and therapeutic strategies.
    Li Y, Liu Y, Liu S, Gao M, et al · · 2023 · cited 392× · PMID 37037849 · DOI 10.1038/s41392-023-01400-z
  2. Diabetic Macular Edema: Current Understanding, Molecular Mechanisms and Therapeutic Implications.
    Zhang J, Zhang J, Zhang C, Zhang J, et al · · 2022 · cited 161× · PMID 36359761 · DOI 10.3390/cells11213362
  3. Ocular delivery of proteins and peptides: Challenges and novel formulation approaches.
    Mandal A, Pal D, Agrahari V, Trinh HM, et al · · 2018 · cited 159× · PMID 29339145 · DOI 10.1016/j.addr.2018.01.008
  4. In vitro-engineered non-antibody protein therapeutics.
    Simeon R, Chen Z. · · 2018 · cited 121× · PMID 28271446 · DOI 10.1007/s13238-017-0386-6
  5. Current and upcoming anti-VEGF therapies and dosing strategies for the treatment of neovascular AMD: a comparative review.
    Khanna S, Komati R, Eichenbaum DA, Hariprasad I, et al · · 2019 · cited 103× · PMID 31909196 · DOI 10.1136/bmjophth-2019-000398
  6. Beyond Antibodies: The DARPin<sup>®</sup> Drug Platform.
    Stumpp MT, Dawson KM, Binz HK. · · 2020 · cited 75× · PMID 32583318 · DOI 10.1007/s40259-020-00429-8
  7. Past, present, and future of anti-IgE biologics.
    Guntern P, Eggel A. · · 2020 · cited 72× · PMID 32249957 · DOI 10.1111/all.14308
  8. Neovascular Age-Related Macular Degeneration (nAMD): A Review of Emerging Treatment Options.
    Tan CS, Ngo WK, Chay IW, Ting DS, et al · · 2022 · cited 69× · PMID 35368240 · DOI 10.2147/opth.s231913

Verify or expand the search:

Other trials of Abicipar Pegol

Trials testing the same drug.

Other recruiting trials for Macular Degeneration

Currently open trials in the same condition.

Other Allergan trials

Trials by the same sponsor.

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