Did the subject meet all the entry criteria?
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (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])
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])