A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy
Condition: Geographic Atrophy
MeSH terms: Geographic Atrophy; Atrophy
Intervention: Sham; Lampalizumab
Intervention description: Sham injection will be administered as a matching intravitreal injection of lampalizumab.; 10 mg dose of lampalizumab administered intravitreally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 96.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No

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.
    

Eligibility 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