A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF LAMPALIZUMAB ADMINISTERED INTRAVITREALLY TO PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATIO
- Conditions
- Geographic Atrophy secondary to age related macular degeneration10047518
- Registration Number
- NL-OMON41786
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
- 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 at starting distance of 4m
- If BCVA letter score is superior or equal to 79 letters (Snellen equivalent of 20/25 or better), at least one GA easion must be within 250 micrometers of the foveal centre.
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 prostate specific 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy outcome measure for this study is GA area at 1 year as<br /><br>assessed by FAF.</p><br>
- Secondary Outcome Measures
Name Time Method