Subretinal Macugen® for Neovascular Age-Related Macular Degeneration

Klinikum Ludwigshafen

Status and phase

Unknown

Phase 3

Conditions

Age-related Macular Degeneration

Treatments

Drug: Pegaptanib (Macugen®)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00788177

AU-06102G

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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