Fovista for Treatment of Naïve Age-Related Macular Degeneration

Status: Recruiting

A phase III randomized, double-masked, controlled trial to establish the safety and efficacy of intravitreous administration of Fovista (anti-PDGF-B pegylated aptamer) administered in combination with Lucentis compared to Lucentis monotherapy in subjects with subfoveal neovascular age-related macular degeneration.

Key Inclusion criteria:

  1. Subfoveal CNV due to AMD with some classic component
  2. BCVA between 20/60 and 20/200 inclusive
  3. Total lesion size ≤ 5 Disc Areas (at least 50% active CNV)
  4. Presence on OCT of subretinal, intraretinal or sub-RPE fluid and/or subretinal thickening/reflectivity consistent with active CNV
  5. Clear ocular media to allow sufficient fundus photo and FA quality
  6. IOP ≤ 21mmHg

Key Exclusion criteria:

  1. Prior treatment in the study eye
  2. More than 25% of total lesion size made up of scarring or atrophy.
  3. More than 50% of total lesion size consisting of subretinal haemorrhage
  4. Presence of Retinal Angiomatous Proliferation (RAP)
  5. Presence of significant PED
  6. Diabetes Mellitus
  7. History or evidence of severe cardiac disease
  8. Stroke within 12 months
  9. Major surgical procedure within 1 month