Genentech GA
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 Patients with Geographic Atrophy

Study Site: We are enrolling patients in this study at the SOUTH location

Ocular Inclusion Criteria: (Study Eye)
  • BCVA of 20/80 to 20/400 inclusive (Snellen equivalent)
  • Well demarcated area of Geographic Atrophy (GA) secondary to AMD
  • GA must be > 1 disc area (DA) (2.54 mm2) in the absence of CNV
  • If GA is multifocal, at least one focal lesion must be > 0.5 DA (1.27 mm2)
  • The total lesion size must be < to 7 DA (17.78 mm2) and must reside completely within the FAF imaging field
  • Presence of hyperautofluorescence adjacent to the are of GA (banded or diffuse perilesional FAF patterns)
  • Sufficient clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging

Ocular Inclusion Criteria: (Fellow [Non-Study] Eye)

  • GA secondary to AMD in the absence of prior or active CNV
Exclusion Criteria:
  • GA in the study eye that extends beyond FAF imaging field or fails to meet single or multifocal lesion criteria
  • Absence or minimal hyperfluorescence adjacent to GA in the study eye (e.g. focal or no perilesional FAF pattern)
  • GA in either eye due to causes other than AMD (e.g. Stargardt disease, cone-rod dystrophy, chloroquine/hydroxychloroquine toxicity)

Ocular Exclusion Criteria: (Study Eye)

  • History of vitrectomy surgery, submacular surgery or other surgical intervention for AMD
  • Previous subfoveal focal laser photocoagulation
  • Laser photocoagulation (juxtafoveal or extrafoveal)
  • Previous intravitreal drug delivery
  • RPE tear involving the macula
  • History of retinal tear
  • Any concurrent ocular or intraocular condition (e.g. cataract or epiretinal membrane) that, in the opinion of the investigator, could do either of the following:
    • Require medical or surgical intervention during the study period to prevent or treat vision loss that might result from that condition; or
    • If allow to progress untreated, could likely contribute to loss of at least two Snellen equivalent lines of BCVA during the study period
  • Active vitreous hemorrhage
  • History of retinal detachment or macular hole (Stage 3 or 4)
  • Glaucoma that is uncontrolled
  • History of corneal transplant

Ocular Exclusion Criteria: (Either Eye)

  • Proliferative diabetic retinopathy
  • Active or history of neovascular (wet) AMD
Principal Investigator:

Dr. Kevin J. Blinder

Sub Investigators:

Dr. Gaurav K. Shah
Dr. Bradley T. Smith

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