A Study of MTP-131 Topical Ophthalmic Solution in Subjects With Diabetic Macular Edema and Non-Exudative Intermediate Age-related Macular Degeneration

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Diabetic Macular Edema, Age-related Macular Degeneration

Intervention / Treatment
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* Drug: MTP-131


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose Regimen<br>MTP-131 (Low Dose) sterile topical ophthalmic solution twice a day into the study eye | Drug: MTP-131<br> <br> |
| Experimental: High Dose Regimen<br>MTP-131 (High Dose) sterile topical ophthalmic solution twice a day into the study eye | Drug: MTP-131<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular edema, Macular degeneration, MTP-131, Ocuvia™