Age-related Macular Degeneration, Diabetic Macular Edema
Conditions
Keywords
Macular edema, Macular degeneration, MTP-131, Ocuvia™
Brief summary
This is a Phase 1/2, open-label, dose-escalation clinical study, enrolling 21 subjects in one of the two treatment groups to determine the effects of topical ocular administration of low dose or high dose MTP-131 given twice a day in subjects with Diabetic Macular Edema and Age-Related Macular Degeneration.
Interventions
DRUGMTP-131
Sponsors
Stealth BioTherapeutics Inc.
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in central subfield thickness | From Baseline to Day 28 |
| Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale | From Baseline to Day 28 |
| Change from Baseline in slit lamp examinations | From Baseline to Day 28 |
| Change from Baseline in intraocular pressure | From Baseline to Day 28 |
| Change from Baseline in dilated fundoscopic examinations | From Baseline to Day 28 |
| Incidence and severity of systemic and ocular adverse events | From Baseline to Day 28 |
| Change from Baseline in vital sign measurements | From Baseline to Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in widefield angiography | From Baseline to Day 28 | Diabetic Macular Edema (DME) subjects only |
| Change from Baseline in fundus autofluorescence pattern including the occurrence of and aggregate size of areas of macular atrophy | From Baseline to Day 28 | Age-Related Macular Degeneration (AMD) subjects only |
| Change from Baseline in best corrected visual acuity (BCVA) as measured with the early treatment diabetic retinopathy study (ETDRS) scale | From baseline to Day 28 | All subjects |
| Change in central subfield thickness | From Baseline to Day 28 | Diabetic Macular Edema (DME) subjects only |
Countries
United States
Outcome results
None listed