Status:
COMPLETED
A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy
Lead Sponsor:
Genentech, Inc.
Conditions:
Geographic Atrophy
Eligibility:
All Genders
60+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Complement Factor I (CFI) profile biomarker-positive result
- Women of child bearing potential and men should remain abstinent or use contraceptive methods
Exclusion
- 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
Key Trial Info
Start Date :
March 30 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2017
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT02288559
Start Date
March 30 2015
End Date
June 2 2017
Last Update
September 25 2019
Active Locations (36)
Enter a location and click search to find clinical trials sorted by distance.
1
Barnet Dulaney Perkins Eye Center
Mesa, Arizona, United States, 85206
2
University of Arizona; Banner University Medical, Department of Opthalmology
Tucson, Arizona, United States, 85711
3
Northwest Arkansas Retina Associates
Springdale, Arkansas, United States, 72764
4
Retinal Diagnostic Center
Campbell, California, United States, 95008