Subretinal Macugen® for Neovascular Age-Related Macular Degeneration

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy of pegaptanib (Macugen®) for neovascular (exudative) age-related macular degeneration (AMD) when the first dose is administered to the submacular space instead of vitreous body in cases when previous state-of-the-art treatment for the AMD was deemed ineffective.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Klinikum Ludwigshafen
• Collaborator: Pfizer

Criteria

Inclusion Criteria:

• 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