SPIOC-101: A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Low Dose Regimen MTP-131 (Low Dose) sterile topical ophthalmic solution twice a day into the study eye |
Drug: MTP-131
|
Experimental: High Dose Regimen MTP-131 (High Dose) sterile topical ophthalmic solution twice a day into the study eye |
Drug: MTP-131
|
Outcome Measures
Primary Outcome Measures
- 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]
- 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]
- Change from Baseline in central subfield thickness [From Baseline to Day 28]
Secondary Outcome Measures
- Change in central subfield thickness [From Baseline to Day 28]
Diabetic Macular Edema (DME) subjects only
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Boston | Massachusetts | United States |
Sponsors and Collaborators
- Stealth BioTherapeutics Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SPIOC-101