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Treatment of retinal angiomatous proliferation lesions due to age-related macular degeneration with ranibizumab (Lucentis®) and photodynamic therapy with verteporfin (Visudyne®) - LUPRA

Phase 1
Conditions
Subtype of neovascular age-related macular degeneration, so called retinal angiomatous proliferation or RAP.
MedDRA version: 8.1Level: LLTClassification code 10015902Term: Exudative senile macular degeneration of retina
Registration Number
EUCTR2006-004367-57-AT
Lead Sponsor
Department of Ophthalmology, Medical University of Graz
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
15
Inclusion Criteria

Patients who at baseline
•have a best corrected visual acuity (BCVA) letter score in the study eye between 73-24 (approximately 20/40 to 20/320) using an ETDRS chart measured at 4 meters or Snellen equivalent
•have a RAP lesion in the study eye with the following characteristics as determined by fluorescein and indocyanine green angiography:

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•any other form of AMD or of neovascular maculopathy, including pathologic myopia, angioid streaks, infectious or inflammatory chorioretinal diseases, ocular tumors, prior radiation therapy, hereditary disorders, or trauma.
•Patients who have a BCVA of < 33 letters (approximately 20/200) in both eyes
•Prior treatment in the study eye with verteporfin, external-beam radiation therapy, vitrectomy, submacular surgery, other surgical intervention for AMD, or transpupillary thermotherapy

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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