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

Genentech

Status and phase: Completed; Phase 2

Conditions: Geographic Atrophy

Treatments: Drug: Lampalizumab; Other: Sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT02288559

GX29455

Details and patient eligibility

About

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.

Enrollment: 96 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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96 participants in 4 patient groups

Lampalizumab: Open-label Safety Run-In

Experimental group

Description:

Participants will receive 10 milligrams (mg) lampalizumab intravitreally Q2W during the safety run-in period.

Treatment:

Drug: Lampalizumab

Q2W Lampalizumab: Randomized Treatment

Experimental group

Description:

Participants will receive 10 mg dose of lampalizumab intravitreally Q2W during the 24-week treatment period.

Treatment:

Drug: Lampalizumab

Q4W Lampalizumab: Randomized Treatment

Experimental group

Description:

Participants will receive 10 mg dose of lampalizumab intravitreally Q4W during the 24-week treatment period.

Treatment:

Drug: Lampalizumab

Sham: Randomized Treatment

Sham Comparator group

Description:

Participants randomized to control arms will receive sham injections, that mimics intravitreal injection of lampalizumab.

Treatment:

Other: Sham