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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Unnamed facility
Boston, Massachusetts, United States
Incidence and severity of systemic and ocular adverse events
Time frame: From Baseline to Day 28
Change from Baseline in vital sign measurements
Time frame: 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
Time frame: From Baseline to Day 28
Change from Baseline in slit lamp examinations
Time frame: From Baseline to Day 28
Change from Baseline in intraocular pressure
Time frame: From Baseline to Day 28
Change from Baseline in dilated fundoscopic examinations
Time frame: From Baseline to Day 28
Change from Baseline in central subfield thickness
Time frame: From Baseline to Day 28
Change in central subfield thickness
Diabetic Macular Edema (DME) subjects only
Time frame: From Baseline to Day 28
Change from Baseline in widefield angiography
Diabetic Macular Edema (DME) subjects only
Time frame: From Baseline to Day 28
Change from Baseline in fundus autofluorescence pattern including the occurrence of and aggregate size of areas of macular atrophy
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Age-Related Macular Degeneration (AMD) subjects only
Time frame: 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
All subjects
Time frame: From baseline to Day 28