Subretinal Macugen® for Neovascular Age-Related Macular Degeneration

• Adults aged 50 years and older with neovascular AMD proven by FA
• Patients who at baseline
• Have a BCVA letter score in the study eye between 20/40 to 20/320 using an ETDRS chart measured at 4 meters or Snellen equivalent
• Have a CNV lesion of any type in the study eye with the following characteristics as determined by fluorescein angiography:
• Evidence that CNV extends under the geometric center of the foveal avascular zone.
• Previous state-of-the-art therapy for the disease is deemed ineffective with following characteristics are given:
• Loss of visual acuity (2 or more Snellen lines) in the previous 3 months defined as either OR
• ≥10% increase in the lesion diameter as assessed by fluorescein angiography in the previous 3 months
• Ability of subject to understand character and individual consequences of clinical trial.
• Signed and dated informed consent of the subject must be available before start of any specific trial procedures.
• Women with childbearing potential practicing a medically accepted contraception (negative pregnancy test result, serum or urine at trial entry).

Exclusion Criteria:

• Subjects presenting with any of the following criteria will not be included in the trial:

  • Have a relevant ocular disease which may be associated with increased intraocular VEGF levels (namely uveitis, neovascular glaucoma, diabetic retinopathy, diabetic maculopathy, ocular ischemic syndrome, retinal vessel occlusion)
  • Had previous vitrectomy surgery for whatsoever reason
  • Are not pseudophakic
  • Have a >50% area of scarring of the whole CNV lesion size as seen in FA
  • Arterial hypertension refractory to medical treatment
  • Pregnancy and lactation.
  • History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
  • Participation in other clinical trials during the present clinical trial or within the last 3 months.
  • Medical or psychological condition that would not permit completion of the trial or signing of informed consent.
  • Suspected or present ocular or periocular infection