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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
Last Update Posted : June 7, 2018
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 GA Area as Measured by Fundus Auto fluorescence (FAF) at Week 24 [ Time Frame: Baseline, Week 24 ]

Secondary Outcome Measures :
  1. Percentage of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: Day 1 up to approximately Day 45 of safety run-in (6 weeks) and hiatus (3 days) assessment period ]
  2. Percentage of Participants With Ocular and Non-Ocular (Systemic) Adverse Events (AEs) [ Time Frame: Baseline up to approximately 2 years ]
  3. Change From Baseline in Best Corrected Visual Acuity (BCVA) Using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart at Week 24 [ Time Frame: Baseline, Week 24 ]
  4. Percentage of Participants With Positive Serum Antibodies to Lampalizumab [ Time Frame: Pre dose (hour 0) on Day 1, Week 4, 8, 16, 24 or early termination (up to 2 years) ]
  5. Maximum Observed Serum Concentration (Cmax) [ Time Frame: Q2W Arm: Pre dose (Hour 0) on Day 1, Week 2, 4, 8, 16, 24; X hours post dose on Day 1; Q4W Arm: Pre dose (Hour 0) on Day 1, Week 4, 8, 16, 24; X hours post dose on Day 1 ]
  6. Time of Maximum Observed Serum Concentration (tmax) [ Time Frame: Q2W Arm: Pre dose (Hour 0) on Day 1, Week 2, 4, 8, 16, 24; X hours post dose on Day 1; Q4W Arm: Pre dose (Hour 0) on Day 1, Week 4, 8, 16, 24; X hours post dose on Day 1 ]
  7. Observed Steady-State Trough Concentration [ Time Frame: Q2W Arm: Pre dose (Hour 0) on Day 1, Week 2, 4, 8, 16, 24; X hours post dose on Day 1; Q4W Arm: Pre dose (Hour 0) on Day 1, Week 4, 8, 16, 24; X hours post dose on Day 1 ]
  8. Accumulation Ratio Based on Trough Concentration [ Time Frame: Q2W Arm: Pre dose (Hour 0) on Day 1, Week 2, 4, 8, 16, 24; X hours post dose on Day 1; Q4W Arm: Pre dose (Hour 0) on Day 1, Week 4, 8, 16, 24; X hours post dose on Day 1 ]

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


  Show 36 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02288559     History of Changes
Other Study ID Numbers: GX29455
First Posted: November 11, 2014    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Atrophy
Geographic Atrophy
Pathological Conditions, Anatomical
Macular Degeneration
Retinal Degeneration
 Retinal Diseases
Eye Diseases
Immunoglobulin Fab Fragments
Immunologic Factors
Physiological Effects of Drugs