Phase 2
N=89
A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy
Geographic Atrophy
Bottom Line
View on ClinicalTrials.gov: NCT02288559 ↗Enrolled (actual)
89
Serious AEs
12.4%
Results posted
Feb 2019
Primary outcome: Primary: Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24 — 0.614; 1.121; 1.049; 0.911 mm^2 — p=0.0428
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sham (Other); Lampalizumab (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24 |
0.614; 1.121; 1.049; 0.911 | 0.0428 sig |
| SECONDARY Serum Concentrations of Lampalizumab (Q2W) |
NA; 1.31; 55.5; 63.6; 64.4; 78.2 | — |
| SECONDARY Serum Concentrations of Lampalizumab (Q4W) |
NA; 2.08; 8.52; 10.3; 8.66; 9.92 | — |
| SECONDARY Percentage of Participants With Ocular Adverse Events (AEs) |
60.0; 9.1; 63.0; 63.6 | — |
| SECONDARY Percentage of Participants With Systemic (Non-ocular) Adverse Events |
40.0; 63.6; 52.2; 50.0 | — |
| SECONDARY Percentage of Participants With Anti-Lampalizumab Antibodies |
0; 0; 1; 1; 0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT02288559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.