Overview

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

Status:
Completed
Trial end date:
2017-06-02
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genentech, Inc.
Treatments:
Immunoglobulin Fab Fragments
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