A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration
Completed · Phase 1/Phase 2
Conditions studied: Diabetic Macular Edema, Age-related Macular Degeneration
In brief
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.
Key facts
- Study ID
- NCT02314299
- Run by
- Stealth BioTherapeutics Inc.
- People needed
- 20
- Starts
- 2014-11-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2015-10-26
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- General:
- Adults aged ≥18 and ≤ 80 years
- 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:
- Central subfield thickness (CST) ≥325 microns as measured by spectral domain optical coherence tomography (SD-OCT) at Screening and Baseline Visits
- BCVA (ETDRS) no better than 20/25 in the study eye
- BCVA (ETDRS) no worse than 20/640 in either eye
- AMD Treatment Group:
- 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)
- BCVA (ETDRS) no worse than 20/400 in either eye
You may not qualify if…
- General:
- Inability to self-administer eye drops
- 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)
- 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
- Have a glycosylated hemoglobin (HbA1c) ≥ 12%
- Ocular Conditions:
- 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
- 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
Where it is running
- Study site — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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