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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Regimen | Experimental | MTP-131 (Low Dose) sterile topical ophthalmic solution twice a day into the study eye |
|
| High Dose Regimen | Experimental | MTP-131 (High Dose) sterile topical ophthalmic solution twice a day into the study eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MTP-131 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in central subfield thickness | Diabetic Macular Edema (DME) subjects only | From Baseline to Day 28 |
| Change from Baseline in widefield angiography | Diabetic Macular Edema (DME) subjects only |
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Inclusion Criteria:
General:
DME Treatment Group:
AMD Treatment Group:
Exclusion Criteria:
General:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston | Massachusetts | United States |
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| From Baseline to Day 28 |
| Change from Baseline in fundus autofluorescence pattern including the occurrence of and aggregate size of areas of macular atrophy | Age-Related Macular Degeneration (AMD) subjects only | 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 | From baseline to Day 28 |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C506540 | arginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamide |
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