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

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• Geographic Atrophy 173
• Atrophy 828

Geographic Atrophy

173 studies on the registry are indexed under Geographic Atrophy; 44 are open to participants now.

This study's enrollment of 96 is above the median of 60 across 131 interventional studies indexed under Geographic Atrophy.

Lead sponsor

Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.

Study arms

• Experimental
  Lampalizumab: Open-label Safety Run-In

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

  Drug: Lampalizumab

• Experimental
  Q2W Lampalizumab: Randomized Treatment

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

  Drug: Lampalizumab

• Experimental
  Q4W Lampalizumab: Randomized Treatment

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

  Drug: Lampalizumab

• Sham comparator
  Sham: Randomized Treatment

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

  Other: Sham

Interventions

• OtherSham

  Sham injection will be administered as a matching intravitreal injection of lampalizumab.

• DrugLampalizumab

  10 mg dose of lampalizumab administered intravitreally

Primary outcomes

1. Change From Baseline in Geographic Atrophy (GA) Area, as Assessed by Fundus Autofluorescence (FAF) at Week 24

   GA or the death of photoreceptors and surrounding cells in the retina, is a common condition in participants with age-related macular degeneration (AMD). The death of these photoreceptors results in lesions that cause vision loss. The change in GA lesion area was measured by FAF and analysis of FAF images was performed by the central reading center. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). BCVA=best corrected visual acuity; ETDRS=Early Treatment Diabetic Retinopathy Scale.

   Time frame: Baseline, Week 24

Secondary outcomes

1. Serum Concentrations of Lampalizumab (Q2W)

   Lower than reportable (LTR) results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of lower limit of quantification (LLOQ) (0.5 nanograms per milliliter (ng/mL)).

   Time frame: Baseline (Day 1, predose and postdose), Weeks 2,4,8,16 and 24, early termination, unscheduled predose and postdose

2. Serum Concentrations of Lampalizumab (Q4W)

   LTR results on pre-dose sample were set to 0, and LTR results on post-dose sample were set to half of LLOQ (0.5 ng/mL).

   Time frame: Baseline (Day 1, predose and postdose), Weeks 4,8,16 and 24, early termination

3. Percentage of Participants With Ocular Adverse Events (AEs)

   An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region.

   Time frame: Baseline up to approximately 30 weeks

4. Percentage of Participants With Systemic (Non-ocular) Adverse Events

   An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Non-ocular AEs were the systemic events.

   Time frame: Baseline up to approximately 30 weeks

5. Percentage of Participants With Anti-Lampalizumab Antibodies

   Having treatment-induced anti-drug antibodies (ADAs) was defined as being ADA-negative at baseline and ADA-positive at any post-baseline timepoint. Having treatment-enhanced ADAs was defined as being ADA-positive at baseline with titer values increased by 0.6 titer units at any post-baseline timepoint.

   Time frame: Baseline up to approximately 30 weeks

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Dec 24, 2015

Documents are hosted by the registry — open the source record to download them.