Back to resultsA Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy
Primary Purpose
Geographic Atrophy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sham
Lampalizumab
Sponsored by
About this trial
This is an interventional treatment trial for Geographic Atrophy
Eligibility Criteria
Inclusion Criteria:
- Complement Factor I (CFI) profile biomarker-positive result
- Women of child bearing potential and men should remain abstinent or use contraceptive methods
Exclusion Criteria:
- History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
- Previous subfoveal focal laser photocoagulation in study eye
- Laser photocoagulation in the study eye
- Prior treatment with external-beam radiation therapy or transpupillary thermotherapy in study eye
- Previous intravitreal drug administration in study eye. A single intraoperative administration of a corticosteroid during cataract surgery at least 3 months prior to screening is permitted
- Previous cell-based intraocular treatment in study eye
- Intraocular surgery in study eye
- Uncontrolled glaucoma and history of glaucoma-filtering surgery in study eye
- History of corneal transplant in study eye
- GA in either eye due to causes other than AMD
- Proliferative diabetic retinopathy in either eye
- Active or history of neovascular (wet) AMD in either eye
- History of idiopathic or autoimmune-associated uveitis, ocular or intraocular conditions, and infectious or inflammatory ocular disease
- Active uveitis and infectious conjunctivitis, keratitis, scleritis or endophthalmitis
- Previous systemic treatment with complement inhibitor and with inhibitors/modulators of visual cycle
- Previous expression vector mediated intraocular treatments
- Uncontrolled blood pressure and atrial fibrillation
- Medical conditions associated with clinically significant risk for bleeding-
- Predisposition or history of increased risk for infection
- Active malignancy within the previous 12 months except for appropriately treated carcinoma in situ of cervix, resolved non-melanoma skin carcinoma, and prostate cancer with a Gleason score of less than or equal to 6, and a stable prostate-specific antigen for greater than or equal to (>/=) 12 months
- History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of lampalizumab injection
- Women of child bearing potential must have a negative serum pregnancy test within 28 days prior to initiation of study treatment
- Previous participation in other studies of investigational drugs
Sites / Locations
- Barnet Dulaney Perkins Eye Center
- University of Arizona; Banner University Medical, Department of Opthalmology
- Northwest Arkansas Retina Associates
- Retinal Diagnostic Center
- The Retina Partners
- Loma Linda University
- San Diego Retina Associates
- West Coast Retina Medical Group
- California Retina Consultants
- Colorado Retina Associates, PC
- Florida Eye Microsurgical Inst
- National Ophthalmic Research Institute
- Florida Eye Associates
- Retina Care Specialists
- Retina Specialty Institute
- Rush University Medical Center
- Wolfe Eye Clinic
- Elman Retina Group
- Vitreoretinal Surgery
- The Retina Institute
- Sierra Eye Associates
- Eye Associates of New Mexico
- Western Carolina Retinal Associate PA
- Char Eye Ear &Throat Assoc
- Cincinnati Eye Institute
- Retina Assoc of Cleveland Inc
- Dean McGee Eye Institute
- Retina Cons of Charleston
- Carolina Retina Center PA
- Charles Retina Institution
- Southeastern Retina Associates
- Tennessee Retina PC.
- W Texas Retina Consultants PA
- Texas Retina Associates
- Retina Specialists
- Wagner Macula & Retina Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Sham Comparator
Arm Label
Lampalizumab: Open-label Safety Run-In
Q2W Lampalizumab: Randomized Treatment
Q4W Lampalizumab: Randomized Treatment
Sham: Randomized Treatment
Arm Description
Participants will receive 10 milligrams (mg) lampalizumab intravitreally Q2W during the safety run-in period.
Participants will receive 10 mg dose of lampalizumab intravitreally Q2W during the 24-week treatment period.
Participants will receive 10 mg dose of lampalizumab intravitreally Q4W during the 24-week treatment period.
Participants randomized to control arms will receive sham injections, that mimics intravitreal injection of lampalizumab.
Outcomes
Primary Outcome Measures
Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24
GA or the death of photoreceptors and surrounding cells in the retina, is a common condition in participants with age-related macular degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Scale.
Secondary Outcome Measures
Serum Concentrations of Lampalizumab (Q2W)
Lower than reportable (LTR) results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of lower limit of quantification (LLOQ) (0.5 nanograms per milliliter (ng/mL)).
Serum Concentrations of Lampalizumab (Q4W)
LTR results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of LLOQ (0.5 ng/mL).
Percentage of Participants With Ocular Adverse Events (AEs)
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.
Percentage of Participants With Systemic (Non-ocular) Adverse Events
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Non-ocular AEs were the systemic events.
Percentage of Participants With Anti-Lampalizumab Antibodies
Having treatment-induced anti-drug antibodies (ADAs) was defined as being ADA-negative at baseline and ADA-positive at any post-baseline timepoint. Having treatment-enhanced ADAs was defined as being ADA-positive at baseline with titer values increased by 0.6 titer units at any post-baseline timepoint.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02288559
Brief Title
A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy
Official Title
A Phase II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Exposure-Response Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Patients With Geographic Atrophy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 30, 2015 (Actual)
Primary Completion Date
June 2, 2017 (Actual)
Study Completion Date
June 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This multicenter, randomized, single-masked, sham injection-controlled study will investigate the exposure-response and safety of lampalizumab administered intravitreally every 2 weeks (Q2W) or every 4 weeks (Q4W) for 24 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). A safety run-in assessment will be conducted prior to initiating enrollment in the randomized study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lampalizumab: Open-label Safety Run-In
Arm Type
Experimental
Arm Description
Participants will receive 10 milligrams (mg) lampalizumab intravitreally Q2W during the safety run-in period.
Arm Title
Q2W Lampalizumab: Randomized Treatment
Arm Type
Experimental
Arm Description
Participants will receive 10 mg dose of lampalizumab intravitreally Q2W during the 24-week treatment period.
Arm Title
Q4W Lampalizumab: Randomized Treatment
Arm Type
Experimental
Arm Description
Participants will receive 10 mg dose of lampalizumab intravitreally Q4W during the 24-week treatment period.
Arm Title
Sham: Randomized Treatment
Arm Type
Sham Comparator
Arm Description
Participants randomized to control arms will receive sham injections, that mimics intravitreal injection of lampalizumab.
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Sham injection will be administered as a matching intravitreal injection of lampalizumab.
Intervention Type
Drug
Intervention Name(s)
Lampalizumab
Intervention Description
10 mg dose of lampalizumab administered intravitreally
Primary Outcome Measure Information:
Title
Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24
Description
GA or the death of photoreceptors and surrounding cells in the retina, is a common condition in participants with age-related macular degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Scale.
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Serum Concentrations of Lampalizumab (Q2W)
Description
Lower than reportable (LTR) results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of lower limit of quantification (LLOQ) (0.5 nanograms per milliliter (ng/mL)).
Time Frame
Baseline (Day 1, predose and postdose), Weeks 2,4,8,16 and 24, early termination, unscheduled predose and postdose
Title
Serum Concentrations of Lampalizumab (Q4W)
Description
LTR results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of LLOQ (0.5 ng/mL).
Time Frame
Baseline (Day 1, predose and postdose), Weeks 4,8,16 and 24, early termination
Title
Percentage of Participants With Ocular Adverse Events (AEs)
Description
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.
Time Frame
Baseline up to approximately 30 weeks
Title
Percentage of Participants With Systemic (Non-ocular) Adverse Events
Description
An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Non-ocular AEs were the systemic events.
Time Frame
Baseline up to approximately 30 weeks
Title
Percentage of Participants With Anti-Lampalizumab Antibodies
Description
Having treatment-induced anti-drug antibodies (ADAs) was defined as being ADA-negative at baseline and ADA-positive at any post-baseline timepoint. Having treatment-enhanced ADAs was defined as being ADA-positive at baseline with titer values increased by 0.6 titer units at any post-baseline timepoint.
Time Frame
Baseline up to approximately 30 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Complement Factor I (CFI) profile biomarker-positive result
Women of child bearing potential and men should remain abstinent or use contraceptive methods
Exclusion Criteria:
History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in study eye
Previous subfoveal focal laser photocoagulation in study eye
Laser photocoagulation in the study eye
Prior treatment with external-beam radiation therapy or transpupillary thermotherapy in study eye
Previous intravitreal drug administration in study eye. A single intraoperative administration of a corticosteroid during cataract surgery at least 3 months prior to screening is permitted
Previous cell-based intraocular treatment in study eye
Intraocular surgery in study eye
Uncontrolled glaucoma and history of glaucoma-filtering surgery in study eye
History of corneal transplant in study eye
GA in either eye due to causes other than AMD
Proliferative diabetic retinopathy in either eye
Active or history of neovascular (wet) AMD in either eye
History of idiopathic or autoimmune-associated uveitis, ocular or intraocular conditions, and infectious or inflammatory ocular disease
Active uveitis and infectious conjunctivitis, keratitis, scleritis or endophthalmitis
Previous systemic treatment with complement inhibitor and with inhibitors/modulators of visual cycle
Previous expression vector mediated intraocular treatments
Uncontrolled blood pressure and atrial fibrillation
Medical conditions associated with clinically significant risk for bleeding-
Predisposition or history of increased risk for infection
Active malignancy within the previous 12 months except for appropriately treated carcinoma in situ of cervix, resolved non-melanoma skin carcinoma, and prostate cancer with a Gleason score of less than or equal to 6, and a stable prostate-specific antigen for greater than or equal to (>/=) 12 months
History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of lampalizumab injection
Women of child bearing potential must have a negative serum pregnancy test within 28 days prior to initiation of study treatment
Previous participation in other studies of investigational drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Barnet Dulaney Perkins Eye Center
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
University of Arizona; Banner University Medical, Department of Opthalmology
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
Northwest Arkansas Retina Associates
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Facility Name
Retinal Diagnostic Center
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
The Retina Partners
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
San Diego Retina Associates
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
West Coast Retina Medical Group
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
California Retina Consultants
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Facility Name
Colorado Retina Associates, PC
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Florida Eye Microsurgical Inst
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Florida Eye Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Retina Care Specialists
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Wolfe Eye Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Elman Retina Group
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Vitreoretinal Surgery
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
The Retina Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Eye Associates of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Western Carolina Retinal Associate PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Char Eye Ear &Throat Assoc
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Retina Assoc of Cleveland Inc
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Dean McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Facility Name
Retina Cons of Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Carolina Retina Center PA
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29223
Country
United States
Facility Name
Charles Retina Institution
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Southeastern Retina Associates
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
Tennessee Retina PC.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
W Texas Retina Consultants PA
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Retina Specialists
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Wagner Macula & Retina Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23451
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy
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