Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Stealth BioTherapeutics Inc.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
General:
1. Adults aged ≥18 and ≤ 80 years
2. Women of childbearing potential must have a negative urine pregnancy test at Baseline and agree to use a highly effective method of contraception throughout the study and 60 days after the last dose of study drug.
DME Treatment Group:
1. Central subfield thickness (CST) ≥325 microns as measured by spectral domain optical coherence tomography (SD-OCT) at Screening and Baseline Visits
2. BCVA (ETDRS) no better than 20/25 in the study eye
3. BCVA (ETDRS) no worse than 20/640 in either eye
AMD Treatment Group:
1. Non-exudative, intermediate age-related macular degeneration defined as an eye(s) having extensive intermediate drusen (10 or more drusen 63μm - 124μm) or large drusen (1 or more ≥125 μm) with no evidence of advanced AMD (i.e., no choroidal neovascularization or macular atrophy)
2. BCVA (ETDRS) no worse than 20/400 in either eye
You may not be if
General:
1. Inability to self-administer eye drops
2. Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve (for example deferoxamine, chloroquine/hydroxychloroquine \[Plaquenil\], tamoxifen, phenothiazines and ethambutol)
3. Any medical condition that, in the opinion of the investigator, would preclude safe participation in the study or completion of all study requirements and examinations
4. Have a glycosylated hemoglobin (HbA1c) ≥ 12%
Ocular Conditions:
1. Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity or successful completion of any study examination
2. Ocular hypertension or glaucoma, dry eye, and any other ocular pathology in the study eye requiring treatment with topical ophthalmic drops
