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NCT02462928: CEDAR

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

Completed Phase 3 Results posted Last updated 28 July 2020
What this trial tests

Phase 3 trial testing Abicipar Pegol in Macular Degeneration in 939 participants. Completed in 19 June 2019.

Timeline
25 June 2015
Primary endpoint
18 April 2018
19 June 2019

Quick facts

Lead sponsorAllergan
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment939
Start date25 June 2015
Primary completion18 April 2018
Estimated completion19 June 2019
Sites151 locations across France, Colombia, Hong Kong, New Zealand, Chile, Austria, Germany, Israel

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 a loss of fewer than 15 letters in BCVA compared to baseline. BCVA was measured using an eye chart and 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 loss of fewer than 15 letters are reported. The study eye is defin

GroupValue95% CI
Abicipar Pegol 2 mg (2Q8)91.7
Abicipar Pegol 2 mg (2Q12)91.2
Ranibizumab 0.5 mg (rQ4)95.5
Mean Change From Baseline in BCVA in the Study Eye at Week 52 Secondary · Baseline to Week 52

BCVA was measured using an eye chart and was 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 study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then t

GroupValue95% CI
Abicipar Pegol 2 mg (2Q8)6.7± 12.9
Abicipar Pegol 2 mg (2Q12)5.6± 13.3
Ranibizumab 0.5 mg (rQ4)8.5± 13.6
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 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. The study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the participant had to select their non-dominant eye for treatment, or el

GroupValue95% CI
Abicipar Pegol 2 mg (2Q8)-141.5± 136.4
Abicipar Pegol 2 mg (2Q12)-150.1± 127.4
Ranibizumab 0.5 mg (rQ4)-141.3± 122.0
Percentage of Participants With a Gain of 15 or More ETDRS Letters in BCVA From Baseline in Study Eye at Week 52 Secondary · Baseline to Week 52

BCVA was measured using an eye chart and 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 study eye is defined as the eye that meets the entry criteria. If both eyes met the entry criteria, the eye with the worse BCVA at baseline (Day 1) was selected as the study eye. If both eyes had same BCVA values at baseline (Day 1), then the p

GroupValue95% CI
Abicipar Pegol 2 mg (2Q8)22.6
Abicipar Pegol 2 mg (2Q12)19.2
Ranibizumab 0.5 mg (rQ4)27.2
Mean Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25) Composite Score in Study Eye 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 related function. The overall composite score is then calculated by averaging over all 11 vision-targeted subscale scores, excluding the general health score. Overall composite score was calculated based on mean of non-missing subscales. Study eye was defined as eye that meets entry crit

GroupValue95% CI
Abicipar Pegol 2 mg (2Q8)2.7± 0.7
Abicipar Pegol 2 mg (2Q12)3.7± 0.7
Ranibizumab 0.5 mg (rQ4)4.6± 0.7

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose to last dose of study drug (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: 92/312 (29%)
Deaths: 8/312
Abicipar Pegol 2 mg (2Q12)
Serious: 102/312 (33%)
Deaths: 7/312
Ranibizumab 0.5 mg (rQ4)
Serious: 95/310 (31%)
Deaths: 11/310

Serious adverse events (287 terms)

ReactionSystemAbicipar Pegol 2 mg (2Q8)Abicipar Pegol 2 mg (2Q12)Ranibizumab 0.5 mg (rQ4)
PneumoniaInfections and infestations
UveitisEye disorders
Retinal vasculitisEye disorders
VitritisEye disorders
BronchitisInfections and infestations
FallInjury, poisoning and procedural complications
Cerebrovascular accidentNervous system disorders
Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders
AnaemiaBlood and lymphatic system disorders
Atrial fibrillationCardiac disorders
Retinal haemorrhageEye disorders
IridocyclitisEye disorders
Visual acuity reducedEye disorders
EndophthalmitisInfections and infestations
Coronary artery diseaseCardiac disorders
Cardiac failure congestiveCardiac disorders
Acute myocardial infarctionCardiac disorders
Retinal artery occlusionEye disorders
CataractEye disorders
Retinal detachmentEye disorders
Hip fractureInjury, poisoning and procedural complications
Femoral neck fractureInjury, poisoning and procedural complications
DehydrationMetabolism and nutrition disorders
OsteoarthritisMusculoskeletal and connective tissue disorders
Back painMusculoskeletal and connective tissue disorders
Other adverse events (21 terms — click to expand)

ReactionSystemAbicipar Pegol 2 mg (2Q8)Abicipar Pegol 2 mg (2Q12)Ranibizumab 0.5 mg (rQ4)
Conjunctival haemorrhageEye disorders
Neovascular age-related macular degenerationEye disorders
NasopharyngitisInfections and infestations
Visual acuity reducedEye disorders
Urinary tract infectionInfections and infestations
CataractEye disorders
HypertensionVascular disorders
Eye painEye disorders
Intraocular pressure increasedInvestigations
InfluenzaInfections and infestations
Retinal haemorrhageEye disorders
BronchitisInfections and infestations
Vitreous floatersEye disorders
Vitreous detachmentEye disorders
ConjunctivitisInfections and infestations
Back painMusculoskeletal and connective tissue disorders
IridocyclitisEye disorders
CoughRespiratory, thoracic and mediastinal disorders
Subretinal fluidEye disorders
FallInjury, poisoning and procedural complications
Eye irritationEye disorders

Most-reported serious reactions: Pneumonia, Uveitis, Retinal vasculitis, Vitritis, Bronchitis, Fall, Cerebrovascular accident, Chronic obstructive pulmonary disease.

Data from ClinicalTrials.gov NCT02462928 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. Retinal and choroidal angiogenesis: a review of new targets.
    Cabral T, Mello LGM, Lima LH, Polido J, et al · · 2017 · cited 114× · PMID 28835854 · DOI 10.1186/s40942-017-0084-9
  6. 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
  7. 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
  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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