Subretinal Macugen® for Neovascular Age-Related Macular Degeneration

Last updated: September 26, 2011
Sponsor: Klinikum Ludwigshafen
Overall Status: Trial Status Unknown

Phase

3

Condition

Macular Degeneration

Aging

Geographic Atrophy

Treatment

N/A

Clinical Study ID

NCT00788177
AU-06102G
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 chartmeasured at 4 meters or Snellen equivalent

  • Have a CNV lesion of any type in the study eye with the following characteristics asdetermined 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 followingcharacteristics are given:

  • Loss of visual acuity (2 or more Snellen lines) in the previous 3 months defined aseither OR

  • ≥10% increase in the lesion diameter as assessed by fluorescein angiography in theprevious 3 months

  • Ability of subject to understand character and individual consequences of clinicaltrial.

  • Signed and dated informed consent of the subject must be available before start of anyspecific trial procedures.

  • Women with childbearing potential practicing a medically accepted contraception (negative pregnancy test result, serum or urine at trial entry).

Exclusion

Exclusion Criteria:

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

  • Have a relevant ocular disease which may be associated with increased intraocularVEGF levels (namely uveitis, neovascular glaucoma, diabetic retinopathy, diabeticmaculopathy, 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 anydrug with similar chemical structure or to any excipient present in thepharmaceutical form of the investigational medicinal product.

  • Participation in other clinical trials during the present clinical trial orwithin the last 3 months.

  • Medical or psychological condition that would not permit completion of the trialor signing of informed consent.

  • Suspected or present ocular or periocular infection

Study Design

Total Participants: 10
Study Start date:
November 01, 2008
Estimated Completion Date:
December 31, 2012

Connect with a study center

  • Department of Ophthalmology, Ludwigshafen hospital

    Ludwigshafen, 67063
    Germany

    Active - Recruiting

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