Macular EdemaPhase 2NCT02186119
A Study of Abicipar Pegol in Patients With Diabetic Macular Edema
A Phase 2 study testing abicipar pegol and ranibizumab in people with Macular Edema, run by Allergan at 2 sites in United States.
Trial summary
This is a safety and efficacy study of abicipar pegol in patients with diabetic macular edema. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Macular Edema
- 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
- 151 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetes mellitus (Type 1 or 2)
- Decreased vision due to diabetic macular edema 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
- Stroke or heart attack within the past 3 months
- History of vitrectomy, macular surgery, or glaucoma surgery in the study eye
- Cataract or refractive surgery in the study eye within the last 3 months
- Laser photocoagulation of the study eye within the last 3 months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Abilene, Texas
Study site
Gilbert, Arizona
About this study
This is a safety and efficacy study of abicipar pegol in patients with diabetic macular edema.
- Conditions
- Macular Edema
- Being tested
- abicipar pegol, ranibizumab, sham procedure
- Medical subject headings
- Macular Edema
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 the visits noted per protocol.
ranibizumabDrug
Also called Lucentis®
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
sham procedureOther
Sham procedure to the study eye at the visits noted per protocol.
| Study group | Role | What they receive |
|---|---|---|
| abicipar pegol 2 mg (group A) | Experimental | Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, and 20, followed by a sham procedure at weeks 12, 16, and 24. Receives: Drug: abicipar pegol; Other: sham procedure |
| abicipar pegol 2 mg (group B) | Experimental | Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20. 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, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20. Receives: Drug: abicipar pegol; Other: sham procedure |
| ranibizumab | Active comparator | Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24. 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)
Measured: Baseline, Week 28
Secondary outcomes (4)
Percentage of Patients with a BCVA Gain of ≥15 Letters in the Study Eye on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
Measured: Baseline, 28 Weeks
Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye
Measured: Baseline, Week 28
Percentage of Patients with a BCVA of ≥70 Letters
Measured: 28 Weeks
Percentage of Patients with Resolution of Macular Edema
Measured: 28 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies 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
- 151 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
- NCT02186119
- Sponsor's protocol ID
- 150998-004
- Other IDs
- PALM
- Status last verified
- Jul 2015
- First submitted
- 8 Jul 2014
- Last updated
- 14 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Abicipar Pegol in Patients With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02186119
- Acronym / sponsor ID
- 150998-004
- Conditions
- Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
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 diabetic macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| abicipar pegol 2 mg (group A) | Experimental | Drug: abicipar pegol, Other: sham procedureAbicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, and 20, followed by a sham procedure at weeks 12, 16, and 24. |
| abicipar pegol 2 mg (group B) | Experimental | Drug: abicipar pegol, Other: sham procedureAbicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20. |
| 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, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20. |
| ranibizumab | Active comparator | Drug: ranibizumabRanibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of diabetes mellitus (Type 1 or 2)
- Decreased vision due to diabetic macular edema 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 (4 listed)
- Stroke or heart attack within the past 3 months
- History of vitrectomy, macular surgery, or glaucoma surgery in the study eye
- Cataract or refractive surgery in the study eye within the last 3 months
- Laser photocoagulation of the study eye within the last 3 months
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 the visits noted per protocol. | Drug | abicipar pegol 1 mg, abicipar pegol 2 mg (group A), abicipar pegol 2 mg (group B) |
| ranibizumabAlso: Lucentis®Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24. | Drug | ranibizumab |
| sham procedureSham procedure to the study eye at the visits noted per protocol. | Other | abicipar pegol 1 mg, abicipar pegol 2 mg (group A), abicipar pegol 2 mg (group B) |
Primary outcome
Change from Baseline in Best Corrected Visual Acuity (BCVA)
Time frame: Baseline, Week 28
4 secondary outcomes
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, 28 Weeks
Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye
Time frame: Baseline, Week 28
Percentage of Patients with a BCVA of ≥70 Letters
Time frame: 28 Weeks
Percentage of Patients with Resolution of Macular Edema
Time frame: 28 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
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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
2 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 Edema, run by Allergan at 2 sites in United States.
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 4 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 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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) (time frame: Baseline, Week 28). 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 14 Jul 2015.