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A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy

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ClinicalTrials.gov Identifier: NCT02288559
Recruitment Status : Completed
First Posted : November 11, 2014
Results First Posted : February 19, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Geographic Atrophy Other: Sham Drug: Lampalizumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : March 30, 2015
Actual Primary Completion Date : June 2, 2017
Actual Study Completion Date : June 2, 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Lampalizumab: Open-label Safety Run-In
Participants will receive 10 milligrams (mg) lampalizumab intravitreally Q2W during the safety run-in period.
 Drug: Lampalizumab
10 mg dose of lampalizumab administered intravitreally
Experimental: Q2W Lampalizumab: Randomized Treatment
Participants will receive 10 mg dose of lampalizumab intravitreally Q2W during the 24-week treatment period.
 Drug: Lampalizumab
10 mg dose of lampalizumab administered intravitreally
Experimental: Q4W Lampalizumab: Randomized Treatment
Participants will receive 10 mg dose of lampalizumab intravitreally Q4W during the 24-week treatment period.
 Drug: Lampalizumab
10 mg dose of lampalizumab administered intravitreally
Sham Comparator: Sham: Randomized Treatment
Participants randomized to control arms will receive sham injections, that mimics intravitreal injection of lampalizumab.
 Other: Sham
Sham injection will be administered as a matching intravitreal injection of lampalizumab.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24 [ Time Frame: Baseline, 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 :
  1. Serum Concentrations of Lampalizumab (Q2W) [ Time Frame: Baseline (Day 1, predose and postdose), Weeks 2,4,8,16 and 24, early termination, unscheduled predose and postdose ]
    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)).

  2. Serum Concentrations of Lampalizumab (Q4W) [ Time Frame: Baseline (Day 1, predose and postdose), Weeks 4,8,16 and 24, early termination ]
    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).

  3. Percentage of Participants With Ocular Adverse Events (AEs) [ Time Frame: Baseline up to approximately 30 weeks ]
    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.

  4. Percentage of Participants With Systemic (Non-ocular) Adverse Events [ Time Frame: Baseline up to approximately 30 weeks ]
    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.

  5. Percentage of Participants With Anti-Lampalizumab Antibodies [ Time Frame: Baseline up to approximately 30 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT02288559


Locations
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Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
  Study Documents (Full-Text)

Documents provided by Genentech, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] December 24, 2015

More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02288559    
Other Study ID Numbers: GX29455
First Posted: November 11, 2014    Key Record Dates
Results First Posted: February 19, 2019
Last Update Posted: September 25, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Geographic Atrophy
Atrophy
Pathological Conditions, Anatomical
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases