DRUG
A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration
Status
Completed
Phase
Phase 1 / Phase 2
Enrollment
20
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Dec 11, 2014
Study start
Nov 2014
Primary completion
May 2015
Study completion
Jun 2015
Results posted
Not reported
Registry updated
Oct 26, 2015
Outcomes
What the study measures.
Primary outcomes
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
Secondary outcomes
Change in central subfield thickness
Time frame · From Baseline to Day 28
Diabetic Macular Edema (DME) subjects only
Change from Baseline in widefield angiography
Time frame · 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
Time frame · 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
Time frame · From baseline to Day 28
All subjects
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Sex
- ALL
- 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/exclusion criteria may apply
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Facility not named
Boston, Massachusetts, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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