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

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

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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