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

Status

Completed

Phase

Phase 1 / Phase 2

Enrollment

20

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

MTP-131

Timeline

From registration to results.

  1. First posted

    Dec 11, 2014

  2. Study start

    Nov 2014

  3. Primary completion

    May 2015

  4. Study completion

    Jun 2015

  5. Results posted

    Not reported

  6. Registry updated

    Oct 26, 2015

Outcomes

What the study measures.

Primary outcomes

Incidence and severity of systemic and ocular adverse events

Time frame · From Baseline to Day 28

Change from Baseline in vital sign measurements

Time frame · 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

Time frame · From Baseline to Day 28

Change from Baseline in slit lamp examinations

Time frame · From Baseline to Day 28

Change from Baseline in intraocular pressure

Time frame · From Baseline to Day 28

Change from Baseline in dilated fundoscopic examinations

Time frame · From Baseline to Day 28

Change from Baseline in central subfield thickness

Time frame · From Baseline to Day 28

Secondary outcomes

Change in central subfield thickness

Time frame · From Baseline to Day 28

Diabetic Macular Edema (DME) subjects only

Change from Baseline in widefield angiography

Time frame · 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

Time frame · 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

Time frame · From baseline to Day 28

All subjects

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * General: 1. Adults aged ≥18 and ≤ 80 years 2. 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: 1. Central subfield thickness (CST) ≥325 microns as measured by spectral domain optical coherence tomography (SD-OCT) at Screening and Baseline Visits 2. BCVA (ETDRS) no better than 20/25 in the study eye 3. BCVA (ETDRS) no worse than 20/640 in either eye * AMD Treatment Group: 1. 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) 2. BCVA (ETDRS) no worse than 20/400 in either eye Exclusion Criteria: * General: 1. Inability to self-administer eye drops 2. 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) 3. 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 4. Have a glycosylated hemoglobin (HbA1c) ≥ 12% * Ocular Conditions: 1. 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 2. 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

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Facility not named

Boston, Massachusetts, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

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