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Trial record 1 of 1 for:    NCT02186119
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A Study of Abicipar Pegol in Patients With Diabetic Macular Edema

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ClinicalTrials.gov Identifier: NCT02186119
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : July 14, 2015
Sponsor:
Information provided by (Responsible Party):
Allergan

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
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.
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.

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.
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.

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.
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.

Active Comparator: ranibizumab
Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
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 :
  1. Change from Baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline, Week 28 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Change from Baseline in Central Retinal Thickness (CRT) in the Study Eye [ Time Frame: Baseline, Week 28 ]
  3. Percentage of Patients with a BCVA of ≥70 Letters [ Time Frame: 28 Weeks ]
  4. 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:
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