A Study of Abicipar Pegol in Patients With Diabetic Macular Edema
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| ClinicalTrials.gov Identifier: NCT02186119 |
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Recruitment Status :
Completed
First Posted : July 10, 2014
Last Update Posted : July 14, 2015
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Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
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Brief Summary:
This is a safety and efficacy study of abicipar pegol in patients with diabetic macular edema.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Macular Edema | Drug: abicipar pegol Drug: ranibizumab Other: sham procedure | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 151 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Study Start Date : | July 2014 |
| Actual Primary Completion Date : | June 2015 |
| Actual Study Completion Date : | June 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Edema
Drug Information available for:
Ranibizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: abicipar pegol 2 mg (group A)
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.
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Drug: abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol. Other: sham procedure Sham procedure to the study eye at the visits noted per protocol. |
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Experimental: abicipar pegol 2 mg (group B)
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.
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Drug: abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol. Other: sham procedure Sham procedure to the study eye at the visits noted per protocol. |
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Experimental: abicipar pegol 1 mg
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.
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Drug: abicipar pegol
Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol. Other: sham procedure Sham procedure to the study eye at the visits noted per protocol. |
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Active Comparator: ranibizumab
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
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Drug: ranibizumab
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
Other Name: Lucentis® |
Primary Outcome Measures :
- Change from Baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline, Week 28 ]
Secondary Outcome Measures :
- 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 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186119
Locations
| United States, Arizona | |
| Gilbert, Arizona, United States | |
| United States, Texas | |
| Abilene, Texas, United States | |
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Medical Director | Allergan |
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT02186119 History of Changes |
| Other Study ID Numbers: |
150998-004 PALM ( Other Identifier: Allergan ) |
| First Posted: | July 10, 2014 Key Record Dates |
| Last Update Posted: | July 14, 2015 |
| Last Verified: | July 2015 |
Additional relevant MeSH terms:
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Edema Macular Edema Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Ranibizumab |
Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |