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39609
Beschreibung
Study ID: 110852 Clinical Study ID: 110852 Study Title: MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01134055 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib eye drops, ranibizumab intravitreal injection, placebo Trade Name: pazopanib, ranibizumab Study Indication: Macular Degeneration
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- 03.02.20 03.02.20 -
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Rechteinhaber
GlaxoSmithKline
Hochgeladen am
3. Februar 2020
DOI
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Creative Commons BY-NC 3.0
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Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055
Screen - Eligibility Criteria
- StudyEvent: ODM
Ähnliche Modelle
Screen - Eligibility Criteria
- StudyEvent: ODM
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
CL Item
Consent (I01)
CL Item
Gender and age (I02)
CL Item
Non-childbearing potential (I03)
CL Item
Study compliance (I04)
CL Item
Subfoveal CNV lesion secondary to AMD (I05A)
CL Item
Evidence of SR or IR fluid by OCT (I05B)
CL Item
Center point thickness that the investigator measures according to Table 5 and which the reading center subsequently confirms by manual measurement (I05C)
CL Item
Lesion characteristics (I06)
CL Item
At least 3 pre-screening anti-VEGF IVT injections. At least 2 of the pre-screening injections must have occurred in the past 6 months. This may include subjects who were first treated as recently as 3 months prior to screening. (I07A)
CL Item
Previous response to anti-VEGF IVT injection therapy, which is defined as a meaningful reduction (at least 50 microns) in center point thickness or equivalent field for given OCT machine. (I07B)
CL Item
Previous response to anti-VEGF IVT injection therapy, which is based on the investigator's judgment that the subject has experienced benefit from anti-VEGF IVT injection therapy and may include information from OCT, FA, VA or other investigator's assessment. (I07D)
CL Item
Investigator anticipates the subject has a continued need for and expected likelihood to benefit from anti-VEGF therapy. (I07C)
CL Item
Visual acuity (I08)
CL Item
Adequate fundus imaging (I09)
CL Item
Liver function tests (I10)
CL Item
QT interval (I11)
CL Item
Evidence of SR or central IR fluid and/or IR cysts by OCT (I05D)
CL Item
CNV treatments (E01)
CL Item
Ocular surgeries (E02)
CL Item
Systemic anti-angiogenic (E03)
CL Item
Medications with ocular toxicity (E04)
CL Item
Investigational drugs/devices (E05)
CL Item
Lesion characteristics (specific to study eye) (E06)
CL Item
Subject is unwilling to refrain from wearing contact lenses starting from the Screening Visit to the Follow-up Visit (E07A)
CL Item
Subject has clinical evidence of diabetic retinopathy or diabetic macular edema. Note, that <= 5 microaneurysms in the absence of diabetes are permissible. (E07B)
CL Item
Subject has any concurrent intraocular condition (for example, cataract or epiretinal membrane) that, in the opinion of the investigator, could require edical or surgical intervention during the study or likely lead to clinically significant effect in VA or retinal thickness. (E07C)
CL Item
Subject is aphakic (E07D)
CL Item
Subject is phakic or pseudophakic with evidence of instability of the intraocular lens (e.g., zonular dehiscence or weakness, displaced lens, vitreous prolaps) (E07E)
CL Item
Subject has active or recent (within 4 weeks) intraocular inflammation. Note, that <= 5 non-inflammatory cells in the anterior chamber field or vitreous are permissible; whereas presence of inflammatory cells is exclusionary. (E07F)
CL Item
Subject has a history of idiopathic or autoimmune-associated uveitis (E07G)
CL Item
Subject has current vitreous hemorrhage (E07H)
CL Item
Subject has a history of rhegmatogenous retinal detachment or macular hole (stage 2 or greater) (E07I)
CL Item
Subject has an active allergic or infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye (E07J)
CL Item
Subject has a spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia. For a subject who has undergone prior refractive or cataract surgery the preoperative refractive error cannot exceed 8 diopters of myopia. (E07K)
CL Item
Subject has uncontrolled glaucoma (intraocular pressure >25 mmHg) despite treatment with anti-glaucoma medication (E07L)
CL Item
Subject is unable to be photographed to document CNV due to cataract obscuring the CNV, known allergy to fluorescein (e.g., bronchospasm, anaphylaxis, rash), lack of venous access, or other reasons (E07M)
CL Item
Subject has other ocular disease or progressive retinal disease likely to affect VA during the study (E07N)
CL Item
Concurrent systemic conditions (E08)
CL Item
Abuse or psychiatric disorder (E09)
CL Item
Other contraindication (E10)