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

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