A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration
Status: | Completed |
---|---|
Conditions: | Cardiology, Ocular, Ocular |
Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 4/21/2016 |
Start Date: | November 2014 |
End Date: | June 2015 |
A Phase 1/2, Open-Label, Dose-Escalation, Single Center, Clinical Study of MTP-131 (Ocuvia™) Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration.
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.
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.
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/exclusion criteria may apply
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