ID

39737

Descripción

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

Palabras clave

Versiones (2)
  1. 3/2/20 3/2/20 -
  2. 14/2/20 14/2/20 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

14 de febrero de 2020

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

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

Inglés

Screen - Eligibility Criteria

1 formularios  
Eligibility Question
Descripción

Eligibility Question

Alias
UMLS CUI-1
C1516637
Did the subject meet all the entry criteria?
Descripción

If No, please select all boxes corresponding to violations of any inclusion/exclusion criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
Consent
Descripción

Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Gender and age
Descripción

Gender and age

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0001779
Non-childbearing potential
Descripción

Non-childbearing potential

Tipo de datos

boolean

Alias
UMLS CUI [1]
C3831118
Study compliance
Descripción

Study compliance

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
Subfoveal CNV lesion secondary to AMD
Descripción

Subfoveal CNV lesion secondary to AMD

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0600518
UMLS CUI [1,2]
C0442185
UMLS CUI [1,3]
C0221198
UMLS CUI [2]
C0242383
Evidence of SR or IR fluid by OCT
Descripción

Evidence of SR or IR fluid by OCT

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1704353
UMLS CUI [1,2]
C0920367
Center point thickness that the investigator measures according to Table 5 and which the reading center subsequently confirms by manual measurement
Descripción

Center point thickness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2735398
Lesion characteristics
Descripción

Lesion characteristics

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1521970
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.
Descripción

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

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332152
UMLS CUI [1,2]
C0220908
UMLS CUI [2,1]
C1554888
UMLS CUI [2,2]
C0596087
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
Descripción

Previous response to anti-VEGF IVT injection therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1554888
UMLS CUI [1,2]
C0596087
UMLS CUI [1,3]
C0521982
UMLS CUI [2,1]
C2735398
UMLS CUI [2,2]
C0547047
UMLS CUI [3]
C0920367
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
Descripción

Intravitreal Injections; Angiogenesis Inhibitors; Response to treatment | Intravitreal Injections; Angiogenesis Inhibitors; benefit | Tomography, Optical Coherence | Assessed; Other

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1554888
UMLS CUI [1,2]
C0596087
UMLS CUI [1,3]
C0521982
UMLS CUI [2,1]
C1554888
UMLS CUI [2,2]
C0596087
UMLS CUI [2,3]
C0814225
UMLS CUI [3]
C0920367
UMLS CUI [4,1]
C1516048
UMLS CUI [4,2]
C0205394
Investigator anticipates the subject has a continued need for and expected likelihood to benefit from anti-VEGF therapy
Descripción

Investigator anticipates the subject has a continued need for and expected likelihood to benefit from anti-VEGF therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027552
UMLS CUI [1,2]
C0549178
UMLS CUI [2,1]
C0033204
UMLS CUI [2,2]
C1517001
UMLS CUI [3,1]
C1554888
UMLS CUI [3,2]
C0596087
UMLS CUI [3,3]
C0814225
Visual acuity
Descripción

Visual acuity

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0042812
Adequate fundus imaging
Descripción

Adequate fundus imaging

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0740422
UMLS CUI [1,2]
C0011923
UMLS CUI [1,3]
C0205411
Liver function tests
Descripción

Liver function tests

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023901
QT interval
Descripción

QT interval

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1287082
Evidence of SR or central IR fluid and/or IR cysts by OCT
Descripción

Evidence of SR or central IR fluid and/or IR cysts by OCT

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0920367
UMLS CUI [1,2]
C1704353
UMLS CUI [2,1]
C0920367
UMLS CUI [2,2]
C0010709
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
CNV treatments
Descripción

CNV treatments

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0600518
UMLS CUI [1,2]
C0087111
Ocular surgeries
Descripción

Ocular surgeries

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C1299003
Systemic anti-angiogenic
Descripción

Systemic anti-angiogenic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0596087
UMLS CUI [1,2]
C1515119
Medications with ocular toxicity
Descripción

Medications with ocular toxicity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013221
UMLS CUI [1,2]
C1299003
Investigational drugs/devices
Descripción

Investigational drugs/devices

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0013230
Lesion characteristics (specific to study eye)
Descripción

Lesion characteristics (specific to study eye)

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1521970
UMLS CUI [2,1]
C0008972
UMLS CUI [2,2]
C0015392
Subject is unwilling to refrain from wearing contact lenses starting from the Screening Visit to the Follow-up Visit
Descripción

Subject is unwilling to refrain from wearing contact lenses starting from the Screening Visit to the Follow-up Visit

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0562955
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0558080
UMLS CUI [2]
C0220908
UMLS CUI [3]
C0589121
Subject has clinical evidence of diabetic retinopathy or diabetic macular edema. Note, that <= 5 microaneurysms in the absence of diabetes are permissible
Descripción

Subject has clinical evidence of diabetic retinopathy or diabetic macular edema

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011884
UMLS CUI [2]
C0730285
UMLS CUI [3]
C0154834
Subject has any concurrent intraocular condition (for example, cataract or epiretinal membrane) that, in the opinion of the investigator, could require medical or surgical intervention during the study or likely lead to clinically significant effect in VA or retinal thickness
Descripción

Intraocular; Disease | Cataract | Epiretinal Membrane | Interventional procedure; Medical | Surgical intervention (finding) | Retina; Thick; Clinical Significance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3282905
UMLS CUI [1,2]
C0012634
UMLS CUI [2]
C0086543
UMLS CUI [3]
C0339543
UMLS CUI [4,1]
C0184661
UMLS CUI [4,2]
C0205476
UMLS CUI [5]
C0549433
UMLS CUI [6,1]
C0035298
UMLS CUI [6,2]
C1280412
UMLS CUI [6,3]
C2826293
Subject is aphakic
Descripción

Subject is aphakic

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0497702
Subject is phakic or pseudophakic with evidence of instability of the intraocular lens (e.g., zonular dehiscence or weakness, displaced lens, vitreous prolaps)
Descripción

Phakic Intraocular Lenses | Posterior-chamber intraocular lens, pseudophakic | Anterior-chamber intraocular lens, pseudophakic | Presence of intraocular lens; Instability | Zonular dehiscence | Lens dislocation | Vitreous prolapse

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1955863
UMLS CUI [2]
C3877842
UMLS CUI [3]
C3880888
UMLS CUI [4,1]
C0496743
UMLS CUI [4,2]
C1444783
UMLS CUI [5]
C1299683
UMLS CUI [6]
C0023309
UMLS CUI [7]
C0155369
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
Descripción

Subject has active or recent (within 4 weeks) intraocular inflammation

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0497211
UMLS CUI [2,1]
C0007634
UMLS CUI [2,2]
C0442743
UMLS CUI [3]
C0003151
UMLS CUI [4]
C0042905
UMLS CUI [5]
C0440752
Subject has a history of idiopathic or autoimmune-associated uveitis
Descripción

Subject has a history of idiopathic or autoimmune-associated uveitis

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042164
UMLS CUI [1,2]
C0332240
UMLS CUI [2,1]
C0042164
UMLS CUI [2,2]
C0004364
Subject has current vitreous hemorrhage
Descripción

Subject has current vitreous hemorrhage

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0042909
UMLS CUI [1,2]
C0521116
Subject has a history of rhegmatogenous retinal detachment or macular hole (stage 2 or greater)
Descripción

Subject has a history of rhegmatogenous retinal detachment or macular hole (stage 2 or greater)

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0271055
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C0024441
UMLS CUI [2,2]
C1306673
Subject has an active allergic or infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
Descripción

Subject has an active allergic or infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009763
UMLS CUI [1,2]
C1527304
UMLS CUI [2]
C0497209
UMLS CUI [3]
C0022568
UMLS CUI [4]
C0036416
UMLS CUI [5]
C0014236
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
Descripción

Refraction measurement findings | Surgical ocular refractive procedure | Cataract surgery | Myopia

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0429585
UMLS CUI [2]
C1274010
UMLS CUI [3]
C2939459
UMLS CUI [4]
C0027092
Subject has uncontrolled glaucoma (intraocular pressure >25 mmHg) despite treatment with anti-glaucoma medication
Descripción

Subject has uncontrolled glaucoma (intraocular pressure >25 mmHg) despite treatment with anti-glaucoma medication

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0017601
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0578862
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C1515995
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
Descripción

Photography; Unable | Choroidal Neovascularization | Cataract | Hypersensitivity; Fluorescein | Bronchial Spasm | anaphylaxis | Exanthema | venous access; Lacking | Other Reason

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0031749
UMLS CUI [1,2]
C1299582
UMLS CUI [2]
C0600518
UMLS CUI [3]
C0086543
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0060520
UMLS CUI [5]
C0006266
UMLS CUI [6]
C0002792
UMLS CUI [7]
C0015230
UMLS CUI [8,1]
C0750164
UMLS CUI [8,2]
C0332268
UMLS CUI [9]
C3840932
Subject has other ocular disease or progressive retinal disease likely to affect VA during the study
Descripción

Subject has other ocular disease or progressive retinal disease likely to affect VA during the study

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0015397
UMLS CUI [1,2]
C0205394
UMLS CUI [2,1]
C1335499
UMLS CUI [2,2]
C0035309
Concurrent systemic conditions
Descripción

Concurrent systemic conditions

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0009488
Abuse or psychiatric disorder
Descripción

Abuse or psychiatric disorder

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038586
UMLS CUI [2]
C0004936
Other contraindication
Descripción

Other contraindication

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0205394
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Similar models

Screen - Eligibility Criteria

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Eligibility Question
C1516637 (UMLS CUI-1)
Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion Criteria
C1512693 (UMLS CUI-1)
Consent
Item
Consent
boolean
C0021430 (UMLS CUI [1])
Gender and age
Item
Gender and age
boolean
C0079399 (UMLS CUI [1,1])
C0001779 (UMLS CUI [1,2])
Non-childbearing potential
Item
Non-childbearing potential
boolean
C3831118 (UMLS CUI [1])
Study compliance
Item
Study compliance
boolean
C1321605 (UMLS CUI [1])
Subfoveal CNV lesion secondary to AMD
Item
Subfoveal CNV lesion secondary to AMD
boolean
C0600518 (UMLS CUI [1,1])
C0442185 (UMLS CUI [1,2])
C0221198 (UMLS CUI [1,3])
C0242383 (UMLS CUI [2])
Evidence of SR or IR fluid by OCT
Item
Evidence of SR or IR fluid by OCT
boolean
C1704353 (UMLS CUI [1,1])
C0920367 (UMLS CUI [1,2])
Center point thickness
Item
Center point thickness that the investigator measures according to Table 5 and which the reading center subsequently confirms by manual measurement
boolean
C2735398 (UMLS CUI [1])
Lesion characteristics
Item
Lesion characteristics
boolean
C0221198 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
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
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.
boolean
C0332152 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
C1554888 (UMLS CUI [2,1])
C0596087 (UMLS CUI [2,2])
Previous response to anti-VEGF IVT injection therapy
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
boolean
C1554888 (UMLS CUI [1,1])
C0596087 (UMLS CUI [1,2])
C0521982 (UMLS CUI [1,3])
C2735398 (UMLS CUI [2,1])
C0547047 (UMLS CUI [2,2])
C0920367 (UMLS CUI [3])
Intravitreal Injections; Angiogenesis Inhibitors; Response to treatment | Intravitreal Injections; Angiogenesis Inhibitors; benefit | Tomography, Optical Coherence | Assessed; Other
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
boolean
C1554888 (UMLS CUI [1,1])
C0596087 (UMLS CUI [1,2])
C0521982 (UMLS CUI [1,3])
C1554888 (UMLS CUI [2,1])
C0596087 (UMLS CUI [2,2])
C0814225 (UMLS CUI [2,3])
C0920367 (UMLS CUI [3])
C1516048 (UMLS CUI [4,1])
C0205394 (UMLS CUI [4,2])
Investigator anticipates the subject has a continued need for and expected likelihood to benefit from anti-VEGF therapy
Item
Investigator anticipates the subject has a continued need for and expected likelihood to benefit from anti-VEGF therapy
boolean
C0027552 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0033204 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
C1554888 (UMLS CUI [3,1])
C0596087 (UMLS CUI [3,2])
C0814225 (UMLS CUI [3,3])
Visual acuity
Item
Visual acuity
boolean
C0042812 (UMLS CUI [1])
Adequate fundus imaging
Item
Adequate fundus imaging
boolean
C0740422 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0205411 (UMLS CUI [1,3])
Liver function tests
Item
Liver function tests
boolean
C0023901 (UMLS CUI [1])
QT interval
Item
QT interval
boolean
C1287082 (UMLS CUI [1])
Evidence of SR or central IR fluid and/or IR cysts by OCT
Item
Evidence of SR or central IR fluid and/or IR cysts by OCT
boolean
C0920367 (UMLS CUI [1,1])
C1704353 (UMLS CUI [1,2])
C0920367 (UMLS CUI [2,1])
C0010709 (UMLS CUI [2,2])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
CNV treatments
Item
CNV treatments
boolean
C0600518 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Ocular surgeries
Item
Ocular surgeries
boolean
C0543467 (UMLS CUI [1,1])
C1299003 (UMLS CUI [1,2])
Systemic anti-angiogenic
Item
Systemic anti-angiogenic
boolean
C0596087 (UMLS CUI [1,1])
C1515119 (UMLS CUI [1,2])
Medications with ocular toxicity
Item
Medications with ocular toxicity
boolean
C0013221 (UMLS CUI [1,1])
C1299003 (UMLS CUI [1,2])
Investigational drugs/devices
Item
Investigational drugs/devices
boolean
C0013230 (UMLS CUI [1])
Lesion characteristics (specific to study eye)
Item
Lesion characteristics (specific to study eye)
boolean
C0221198 (UMLS CUI [1,1])
C1521970 (UMLS CUI [1,2])
C0008972 (UMLS CUI [2,1])
C0015392 (UMLS CUI [2,2])
Subject is unwilling to refrain from wearing contact lenses starting from the Screening Visit to the Follow-up Visit
Item
Subject is unwilling to refrain from wearing contact lenses starting from the Screening Visit to the Follow-up Visit
boolean
C0562955 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C0220908 (UMLS CUI [2])
C0589121 (UMLS CUI [3])
Subject has clinical evidence of diabetic retinopathy or diabetic macular edema
Item
Subject has clinical evidence of diabetic retinopathy or diabetic macular edema. Note, that <= 5 microaneurysms in the absence of diabetes are permissible
boolean
C0011884 (UMLS CUI [1])
C0730285 (UMLS CUI [2])
C0154834 (UMLS CUI [3])
Intraocular; Disease | Cataract | Epiretinal Membrane | Interventional procedure; Medical | Surgical intervention (finding) | Retina; Thick; Clinical Significance
Item
Subject has any concurrent intraocular condition (for example, cataract or epiretinal membrane) that, in the opinion of the investigator, could require medical or surgical intervention during the study or likely lead to clinically significant effect in VA or retinal thickness
boolean
C3282905 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0086543 (UMLS CUI [2])
C0339543 (UMLS CUI [3])
C0184661 (UMLS CUI [4,1])
C0205476 (UMLS CUI [4,2])
C0549433 (UMLS CUI [5])
C0035298 (UMLS CUI [6,1])
C1280412 (UMLS CUI [6,2])
C2826293 (UMLS CUI [6,3])
Subject is aphakic
Item
Subject is aphakic
boolean
C0497702 (UMLS CUI [1])
Phakic Intraocular Lenses | Posterior-chamber intraocular lens, pseudophakic | Anterior-chamber intraocular lens, pseudophakic | Presence of intraocular lens; Instability | Zonular dehiscence | Lens dislocation | Vitreous prolapse
Item
Subject is phakic or pseudophakic with evidence of instability of the intraocular lens (e.g., zonular dehiscence or weakness, displaced lens, vitreous prolaps)
boolean
C1955863 (UMLS CUI [1])
C3877842 (UMLS CUI [2])
C3880888 (UMLS CUI [3])
C0496743 (UMLS CUI [4,1])
C1444783 (UMLS CUI [4,2])
C1299683 (UMLS CUI [5])
C0023309 (UMLS CUI [6])
C0155369 (UMLS CUI [7])
Subject has active or recent (within 4 weeks) intraocular inflammation
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
boolean
C0497211 (UMLS CUI [1])
C0007634 (UMLS CUI [2,1])
C0442743 (UMLS CUI [2,2])
C0003151 (UMLS CUI [3])
C0042905 (UMLS CUI [4])
C0440752 (UMLS CUI [5])
Subject has a history of idiopathic or autoimmune-associated uveitis
Item
Subject has a history of idiopathic or autoimmune-associated uveitis
boolean
C0042164 (UMLS CUI [1,1])
C0332240 (UMLS CUI [1,2])
C0042164 (UMLS CUI [2,1])
C0004364 (UMLS CUI [2,2])
Subject has current vitreous hemorrhage
Item
Subject has current vitreous hemorrhage
boolean
C0042909 (UMLS CUI [1,1])
C0521116 (UMLS CUI [1,2])
Subject has a history of rhegmatogenous retinal detachment or macular hole (stage 2 or greater)
Item
Subject has a history of rhegmatogenous retinal detachment or macular hole (stage 2 or greater)
boolean
C0271055 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C0024441 (UMLS CUI [2,1])
C1306673 (UMLS CUI [2,2])
Subject has an active allergic or infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
Item
Subject has an active allergic or infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
boolean
C0009763 (UMLS CUI [1,1])
C1527304 (UMLS CUI [1,2])
C0497209 (UMLS CUI [2])
C0022568 (UMLS CUI [3])
C0036416 (UMLS CUI [4])
C0014236 (UMLS CUI [5])
Refraction measurement findings | Surgical ocular refractive procedure | Cataract surgery | Myopia
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
boolean
C0429585 (UMLS CUI [1])
C1274010 (UMLS CUI [2])
C2939459 (UMLS CUI [3])
C0027092 (UMLS CUI [4])
Subject has uncontrolled glaucoma (intraocular pressure >25 mmHg) despite treatment with anti-glaucoma medication
Item
Subject has uncontrolled glaucoma (intraocular pressure >25 mmHg) despite treatment with anti-glaucoma medication
boolean
C0017601 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0578862 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1515995 (UMLS CUI [2,3])
Photography; Unable | Choroidal Neovascularization | Cataract | Hypersensitivity; Fluorescein | Bronchial Spasm | anaphylaxis | Exanthema | venous access; Lacking | Other Reason
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
boolean
C0031749 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0600518 (UMLS CUI [2])
C0086543 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0060520 (UMLS CUI [4,2])
C0006266 (UMLS CUI [5])
C0002792 (UMLS CUI [6])
C0015230 (UMLS CUI [7])
C0750164 (UMLS CUI [8,1])
C0332268 (UMLS CUI [8,2])
C3840932 (UMLS CUI [9])
Subject has other ocular disease or progressive retinal disease likely to affect VA during the study
Item
Subject has other ocular disease or progressive retinal disease likely to affect VA during the study
boolean
C0015397 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1335499 (UMLS CUI [2,1])
C0035309 (UMLS CUI [2,2])
Concurrent systemic conditions
Item
Concurrent systemic conditions
boolean
C0009488 (UMLS CUI [1])
Abuse or psychiatric disorder
Item
Abuse or psychiatric disorder
boolean
C0038586 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Other contraindication
Item
Other contraindication
boolean
C1301624 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
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