Macular DegenerationPhase 2NCT02181504
A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration
A Phase 2 study testing abicipar pegol and ranibizumab in people with Macular Degeneration, run by Allergan at 11 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- abicipar pegol and ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 11 sitesJapan
- Study dates
- Sep 2014to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ethnically Japanese
- Diagnosis of wet age-related macular degeneration in at least 1 eye
- Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye
Who cannot join
- Hypersensitivity, allergy, or anaphylactic reaction to iodine or shellfish
- Cataract or refractive surgery within the last 3 months
- History of vitrectomy
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Japan11 sites
Nihon University Hospital
Chiyoda-ku,Tokyo, 101-8309
1 Fukushima Medical University
Fukushima, 960-1295
Kyushu University Hospital
Kita-ku, Fukuoka-shi Fukuoka, 812-8582
Okayama University Hospital
Kita-ku, Okayama-shi Okayama, 700-8558
Shiga University
Ōtsu, 520-2192
Tokyo Women's Medical University
Shinjuku-ku, 162-8666
Nagoya University Hospital
Showa-ku, Nagoya-shi Aichi, 466-8560
Takeuchi Eye Clinic
Taito Ku Tokyo, 111-0051
Musashi Dream Clinic
Tennoji-ku Osaka, 543-0027
Juntendo University Urayas
Urayasu-shi, 279-0021
Otakeganka Tsukimino Clinic
Yamato Kanagawa, 242-0001
About this study
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.
- Conditions
- Macular Degeneration
- Being tested
- abicipar pegol, ranibizumab, sham procedure
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abicipar pegolDrug
Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.
ranibizumabDrug
Also called Lucentis®
Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
sham procedureOther
Sham procedure to the study eye at weeks 12 and 16.
| Study group | Role | What they receive |
|---|---|---|
| abicipar pegol 2 mg | Experimental | 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. Receives: Drug: abicipar pegol; Other: sham procedure |
| abicipar pegol 1 mg | Experimental | 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. Receives: Drug: abicipar pegol; Other: sham procedure |
| ranibizumab 0.5 mg | Active comparator | Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16. Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (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 (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.
Measured: Baseline, Week 16
Secondary outcomes (4)
Change From Baseline in BCVA in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (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 (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.
Measured: Baseline, Week 20
Percentage of Patients With a BCVA Gain of ≥15 Letters in the Study Eye on 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. The percentage of patients with a BCVA gain of ≥15 letters are noted.
Measured: Baseline, 20 Weeks
Percentage of Patients With a BCVA Gain of ≥10 Letters in the Study Eye on 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. The percentage of patients with a BCVA gain of ≥10 letters are noted.
Measured: Baseline, 20 Weeks
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
CRT is 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.
Measured: Baseline, Week 16, Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181504
- Sponsor's protocol ID
- 150998-002
- Other IDs
- BAMBOO
- Status last verified
- Mar 2017
- First submitted
- 2 Jul 2014
- Last updated
- 25 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02181504
- Acronym / sponsor ID
- 150998-002
- Conditions
- Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Jul 2014 (estimated)
- Results
- Posted 25 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| abicipar pegol 2 mg | Experimental | Drug: abicipar pegol, Other: sham procedureAbicipar 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. |
| abicipar pegol 1 mg | Experimental | Drug: abicipar pegol, Other: sham procedureAbicipar 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. |
| ranibizumab 0.5 mg | Active comparator | Drug: ranibizumabRanibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ethnically Japanese
- Diagnosis of wet age-related macular degeneration in at least 1 eye
- Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better in the fellow eye
Key exclusion criteria (3 listed)
- Hypersensitivity, allergy, or anaphylactic reaction to iodine or shellfish
- Cataract or refractive surgery within the last 3 months
- History of vitrectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abicipar pegolAbicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8. | Drug | abicipar pegol 1 mg, abicipar pegol 2 mg |
| ranibizumabAlso: Lucentis®Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16. | Drug | ranibizumab 0.5 mg |
| sham procedureSham procedure to the study eye at weeks 12 and 16. | Other | abicipar pegol 1 mg, abicipar pegol 2 mg |
Primary outcome
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time frame: Baseline, Week 16
BCVA is measured using an eye chart and is reported as the number of letters read correctly (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 (positive number change from baseline) in the number of letters read correctly means that vision has improved and a decrease (negative number change from baseline) in the number of letters read correctly means that vision has worsened.
4 secondary outcomes
Change From Baseline in BCVA in the Study Eye
Time frame: Baseline, Week 20
Percentage of Patients With a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
Time frame: Baseline, 20 Weeks
Percentage of Patients With a BCVA Gain of ≥10 Letters in the Study Eye on the ETDRS Scale
Time frame: Baseline, 20 Weeks
Change From Baseline in Central Retinal Thickness (CRT) in the Study Eye
Time frame: Baseline, Week 16, Week 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing abicipar pegol and ranibizumab in people with Macular Degeneration, run by Allergan at 11 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.