Phase
Condition
Macular Degeneration
Aging
Geographic Atrophy
Treatment
N/AClinical Study ID
Ages > 50 All Genders
Study Summary
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
Connect with a study center
Department of Ophthalmology, Ludwigshafen hospital
Ludwigshafen, 67063
GermanyActive - Recruiting
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