A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration (Study #1)
- Conditions
- Geographic atrophyMedDRA version: 20.1Level: LLTClassification code 10063947Term: Geographic atrophySystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2014-000107-27-AT
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 936
- Willingness and the ability to provide signed informed consent; additionally, at U.S. sites, patients must provide Health Insurance Portability and Accountability Act (HIPAA) authorization, and in other countries, as applicable according to national laws
- Participants aged >/= 50 years
Ocular Inclusion Criteria: Study Eye
- Well demarcated area(s) of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV)
- BCVA letter score superior or equal to 49 letters (Snellen equivalent of 20/100 or better) using ETDRS charts at starting distance of 4 m
If BCVA letter score is superior or equal to 79 letters (Snellen equivalent
of 20/25 or better), at least one GA lesion must be within 250 micrometers of the foveal centre.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 187
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 749
GA Characteristics Exclusion Criteria
- GA in either eye due to causes other than AMD (monogenetic macular dystrophies [e.g., Stargardt disease, cone rod dystrophy] or toxic maculopathies [e.g., chloroquine/hydroxychloroquine maculopathy])
Ocular Exclusion Criteria: Study Eye
- History of vitrectomy surgery, submacular surgery, or any other surgical intervention for AMD
- Previous laser photocoagulation for CNV, diabetic macular edema, retinal vein occlusion, and proliferative diabetic retinopathy
- Prior treatment with Visudyne®, external-beam radiation therapy (for intraocular conditions), or transpupillary thermotherapy
- History of prophylactic subthreshold laser treatment for AMD
- Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection, anti-angiogenic drugs, anti-complement agents, or device implantation). A single intraoperative administration of a corticosteroid during cataract surgery for cystoid macular edema prophylaxis at least 3 months prior to screening is permitted.
Ocular Exclusion Criteria: Non-study eye
- Non-functioning non-study eye defined as either:
BCVA of hand motion or worse OR no physical presence of non-study eye (i.e., monocular)
Ocular Exclusion Criteria: Both Eyes
- Previous participation in interventional clinical trials for geographic atrophy or dry AMD (except of vitamins and minerals) irrespective of the route of administration (ocular or systemic)
- Previous treatment with eculizumab, lampalizumab, fenretidine or any
other drugs for geographic atrophy or dry AMD treatment
Concurrent Systemic Conditions Exclusion Criteria
- Uncontrolled blood pressure (defined as systolic >180 mm Hg and/or diastolic >110 mm Hg while patient is sitting) If a patient’s initial measurement exceeds these values, a second reading may be taken 30 or more minutes later. If the patient’s blood pressure must be controlled by anti hypertensive medication, the patient can become eligible if medication is taken continuously for at least 30 days prior to Day 1.
- History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that contraindicates the use of lampalizumab or that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications
- Treatment for active systemic infection or localized infection. The
ongoing prophylactic use of antimicrobial therapy should be discussed with the Medical Monitor.
- Predisposition or history of increased risk of infection
- Active malignancy within past 12 months except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma and prostate cancer with a Gleason score of < 6 and a stable prostatespecific antigen (PSA) for > 12 months.
- History of allergy to fluorescein that is not amenable to treatment
- History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lampalizumab injection
- Inability to comply with study or follow-up procedures
- Inability to obtain CFP, FAF, and FA of sufficient quality to be analyzed and graded by the central reading center
- Previous participation in any studies of investigational drugs within 3 months (except as listed in protocol section 4.1.2d) preceding Day 1 (excluding vitamins and minerals)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy and safety of 10 mg lampalizumab intravitreal injections of administered every 4 weeks (Q4W) or every 6 weeks (Q6W) in patients compared with sham control assessed by change in the geographic atrophy (GA) area from baseline as measured by fundus autofluorescence (FAF).;Secondary Objective: To evaluate the effect of lampalizumab compared with sham control with the use of secondary assessments BCVA, microperimetry, reading charts and patient reported questionnaires.;Primary end point(s): Change in GA area, as assessed by fundus autofluorescence (FAF);Timepoint(s) of evaluation of this end point: From baseline to Week 48
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Change in best corrected visual acuity (BCVA), as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 m<br>- Change in BCVA, as assessed by the ETDRS chart (at a starting distance of 4 m) under low luminance conditions<br><br>Safety: <br>- Incidence of adverse events relative to sham<br>- Proportion of patients with confirmed anti-therapeutic antibodies directed against lampalizumab;Timepoint(s) of evaluation of this end point: From baseline to 2 years