A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 60 - Any |
Updated: | 2/21/2019 |
Start Date: | March 30, 2015 |
End Date: | June 2, 2017 |
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
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.
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.
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
We found this trial at
36
sites
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Loma Linda University Loma Linda University (LLU) is a Seventh-day Adventist educational health-sciences institution with...
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655 North Alvernon Way
Tucson, Arizona 85711
Tucson, Arizona 85711
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