Clinical Trial: A Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Participants With Geographic Atrophy
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase II, Multicenter, Randomized, Single-Masked, Sham Injection-Controlled Exposure-Response Study of Lampalizumab Intravitreal Injections Administered Every Two Weeks or Every Four Weeks to Patien
Brief 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.
Detailed Summary:
Sponsor: Genentech, Inc.
Current Primary Outcome: Change From Baseline in GA Area as Measured by Fundus Auto fluorescence (FAF) at Week 24 [ Time Frame: Baseline, Week 24 ]
Original Primary Outcome: Efficacy: Mean change in GA area, as measured by FAF [ Time Frame: From baseline to Week 24 ]
Current Secondary Outcome:
- Percentage of Participants With Dose-Limiting Toxicities (DLTs) [ Time Frame: Day 1 up to approximately Day 45 of safety run-in (6 weeks) and hiatus (3 days) assessment period ]
- Percentage of Participants With Ocular and Non-Ocular (Systemic) Adverse Events (AEs) [ Time Frame: Baseline up to approximately 2 years ]
- Change From Baseline in Best Corrected Visual Acuity (BCVA) Using the Early Treatment of Diabetic Retinopathy Study (ETDRS) Visual Acuity Chart at Week 24 [ Time Frame: Baseline, Week 24 ]
- Percentage of Participants With Positive Serum Antibodies to Lampalizumab [ Time Frame: Pre dose (hour 0) on Day 1, Week 4, 8, 16, 24 or early termination (up to 2 years) ]
- Maximum Observed Serum Concentration (Cmax) [ Time Frame: Q2W Arm: Pre dose (Hour 0) on Day 1, Week 2, 4, 8, 16, 24; X hours post dose on Day 1; Q4W Arm: Pre dose (Hour 0) on Day 1, Week 4, 8, 16, 24; X hours post dose on Day 1 ]
- Time of Maximum Observed Serum Concentration (tmax) [ Time Frame: Q2W Arm: Pre dose (Hour 0) on Day 1, Week 2, 4, 8, 16, 24; X hours post dose on Day 1; Q4W Arm: Pre dose (Hour 0) on Day 1, Week 4, 8, 16, 24; X hours post dose on Day 1 ]
- Observed Steady-State Trough Concentration [ Time Frame: Q2W Arm: Pre dose (Hour 0) on Day 1, Week 2, 4, 8, 16, 24; X hours post dose on Day 1; Q4W Arm: Pre dose (Hour 0) on Day 1, Week 4, 8, 16, 24; X hours post dose on Day 1 ]
- Accumulation Ratio Based on Trough Concentration [ Time Frame: Q2W Arm: Pre dose (Hour 0) on Day 1, Week 2, 4, 8, 16, 24; X hours post dose on Day 1; Q4W Arm: Pre dose (Hour 0) on Day 1, Week 4, 8, 16, 24; X hours post dose on Day 1 ]
Original Secondary Outcome:
- Safety (composite outcome measure): Incidence and severity of ocular and non-ocular (systemic) adverse events [ Time Frame: From baseline to Week 24 ]
- Pharmacokinetic profile derived from the serum concentration-time data following administration of lampalizumab [ Time Frame: Up to 24 weeks ]
Information By: Genentech, Inc.
Dates:
Date Received: November 7, 2014
Date Started: March 30, 2015
Date Completion: June 30, 2017
Last Updated: May 8, 2017
Last Verified: May 2017