Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Daiichi Sankyo
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
For parts 1 and 2:
≥ 50 years of age
Has active primary subfoveal choroid neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD)
CNV ≥ 50% of total lesion size in study eye
Central sub-field thickness \> 315 µm on spectral domain optical coherence tomography (SD-OCT) in the study eye
Has BCVA letter score required at screening visit:
For Part 1, ≤ 49 (approximately 20/100 or worse) in the study eye and ≥ 49 (approximately 20/100 or better) in the fellow eye
For Part 2, 78 to 25 (approximately 20/32 to 20/320) in the study eye
For Part 3:
Is ≥ 18 years of age with retinal thickening due to diabetic macular edema (DME)
Has central sub-field thickness (CST) \> 335 μm in the study eye
Has BCVA letter score at screening visit 78 to 25 letters (approximately 20/32 to 20/320) in the study eye
You may not be if
For Parts 1 and 2:
Has used any long acting steroids, either systemically or intraocularly, within 6 months of Baseline Visit
Has total lesion size \> 12 disc areas (30.5 mm2) in the study eye
Has presence of retinal pigment epithelial tears or rips involving the macula in the study eye
Has history of any vitreous hemorrhage within 4 weeks prior to Screening Visit in the study eye
Has presence of causes of CNV other than AMD
Had prior vitrectomy in the study eye
Has history of retinal detachment or treatment or surgery for retinal detachment in the study eye
Has any history of a full thickness macular hole in the study eye
Had any intraocular or periocular surgery within 3 months of Baseline Visit on the study eye, except lid surgery
Has uncontrolled glaucoma in the study eye
Has active intraocular inflammation or periocular infection in either eye
Has any history of uveitis in either eye of scleromalacia in either eye
Has aphakia or pseudophakia in the study eye
Had previous therapeutic radiation in the region of the study eye
Has history of corneal transplant or corneal dystrophy in the study eye
Has significant media opacities in the study eye (e.g. cataract) that could require either medical or surgical intervention during the study period
Is a women who is pregnant, breastfeeding, or of childbearing potential and unwilling to practice two measures of adequate contraception throughout the study
For Part 1 only:
Had any ocular (in the study eye) or systemic treatment or surgery for neovascular AMD within 4 weeks of Baseline Visit, except dietary supplements or vitamins
Has a subretinal hemorrhage that is ≥ 50% of the total lesion area in the study eye
Has scarring or fibrosis, making up \>50% of total lesion or involving the center of the fovea in the study eye
For Part 2 only:
Had any prior therapy in the study eye within 3 months of Baseline Visit, except dietary supplements or vitamins
For Part 3:
Has used any steroids, either systemically or ocular in the study eye (other than fluocinolone), within 6 months of Baseline Visit
Has macular edema in the study eye considered to be due to a cause other than DME
Has high-risk proliferative diabetic retinopathy (PDR) in the study eye
Has decrease in BCVA in the study eye due to causes other than DME
Has significant macular ischemia in the study
Has choroidal neovascularization (CNV) secondary to any etiology
Has retinal pigment epithelial tears or rips involving the macula in the study eye
Had any vitreous hemorrhage within 4 weeks prior to Screening/Visit 1 in the study eye
Had prior vitrectomy in the study eye
Has history of retinal detachment or treatment or surgery for retinal detachment in the study eye
Has history of a full thickness macular hole in the study eye
Had any intraocular or periocular surgery within 3 months of Baseline Visit
Has uncontrolled glaucoma in the study eye
Had prior trabeculectomy or other filtration surgery in the study eye
Has active intraocular inflammation or periocular infection in either eye
Has current or history of scleromalacia in either eye
Has aphakia or pseudophakia with absence of posterior capsule
Has previous therapeutic radiation in the region of the study eye
Has history of corneal transplant or corneal dystrophy in the study eye
Has concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of safety, tolerability, or efficacy
Has systolic blood pressure ≥160 mmHg and/or a diastolic blood pressure ≥95 mmHg at Screening
Has an estimated Glomerular Filtration Rate (eGFR) of \< 15 mL/min/1.73 m\^2 as per the creatinine equation (CKD-EPI) at Screening
Has any history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
Is a women who is pregnant, breastfeeding, or of childbearing potential and unwilling to practice two measures of adequate contraception throughout the study
Clareo Health | Study of DS-7080a for the Treatment of Macular Degeneration
