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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT02288559
First received: November 7, 2014
Last updated: September 4, 2017
Last verified: September 2017
  Purpose
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 Intervention Phase
Geographic Atrophy Other: Sham Drug: Lampalizumab Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Change From Baseline in GA Area as Measured by Fundus Auto fluorescence (FAF) at Week 24 [ Time Frame: Baseline, Week 24 ]

Secondary Outcome Measures:
  • 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 ]
  • Percentage of Participants With Ocular and Non-Ocular (Systemic) Adverse Events (AEs) [ Time Frame: Baseline up to approximately 2 years ]
  • 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 ]
  • 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) ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 96
Actual Study Start Date: March 30, 2015
Study Completion Date: June 2, 2017
Primary Completion Date: June 2, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02288559

  Show 37 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02288559     History of Changes
Other Study ID Numbers: GX29455
Study First Received: November 7, 2014
Last Updated: September 4, 2017

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

ClinicalTrials.gov processed this record on September 19, 2017